Thaumatec HealthTech Industry Update | Hospitals need Patient Trust in GenAI

Hospitals need to start thinking about ways to build patients’ trust in generative AI in order for the healthcare industry to fully harness the technology’s potential. They can do this through methods like having transparent conversations, asking for patients’ consent to use the tools and training models on internal data, experts said.

Hospitals can build greater patient trust in generative AI models — through methods like having transparent conversations, asking for patients’ consent to use the tools and training models on internal data, said an AI expert at Deloitte and clinical leaders at health systems.

What do hospitals need to know about consumer attitudes toward generative AI?

Compared to Deloitte’s 2023 survey on consumers’ attitudes toward generative AI in healthcare, distrust in the technology has increased for all age groups — with the sharpest jumps occurring among Millennials and Baby Boomers. Millennials’ distrust in the information provided by generative AI rose from 21% to 30%, while Baby Boomers’ distrust rose from 24% to 32%.

Consumers have free reign to experiment with generative AI and use it in their daily lives, thanks to the availability of public models like OpenAI’s ChatGPT or Google’s Gemini. Many Americans have ended up receiving questionable or inaccurate information when using these models, and these experiences may be causing people to view the technology as unfit for use in healthcare settings.

Free, publicly available large language models aren’t trained on specific patient data and therefore aren’t always accurate when answering healthcare-related questions. A recent study found that ChatGPT misdiagnosed 83 out of 100 paediatric medical cases.

Ideally, hospitals should be training their generative AI models on their own patient data, using synthetic data or data from similar healthcare providers to fill in any gaps and it is recommended that hospitals educate their patients about how and why generative AI is being used at their organization — as well as pay attention to patients’ feedback.

If hospitals take the time to walk patients through the generative AI models they’re applying to patient care and what benefits these models are designed to deliver, patients can gain a true understanding that the AI isn’t there to replace their doctor, but rather augment the doctor’s abilities to provide better quality care.

Explaining the benefits

Americans’ understanding of technology differs greatly from person to person, and large portions of the population may not know exactly what the term AI refers to. Because of this, some patients might feel frightened when they initially hear that a non-human form of intelligence is being used in their care — but their feelings will most likely change once the technology is thoroughly explained to them.

In Muro’s view, generative AI can be thought of as a research partner. The technology uses data to produce content for clinicians, such as the draft of a clinical note, summary of patient records and or overview of medical research. Clinicians always have the final say in care decisions, so generative AI is by no means replacing their expertise. Instead, it is reducing the amount of mundane, data-oriented tasks clinicians have to complete so they can spend more time with patients. When having conversations with patients, providers must make sure that they understand this.

Providers should also be clear about the specific use cases to which they are applying generative AI, as explaining these use cases will give patients a better idea of how the technology might stand to benefit them.

For example, a doctor treating a patient may want to check how patients with similar symptoms and profiles were cared for in the past. Instead of digging through records and filtering them, the clinicians can ask a generative AI tool a simple question and get started on the process of devising a care plan for their patient much sooner, Muro explained.

Relationships are at the heart of trust

Providers need to take the time to explain how AI is being used to enhance care. These conversations are most meaningful when they happen directly between a patient and their care team.

Strong provider-patient relationships are key to building trust in the healthcare world, Runnels pointed out. Patients are more likely to understand and accept the benefits of generative AI tools when they are explained by a provider who they know and are comfortable with.

It should be the care team’s responsibility to inform patients about generative AI use cases.

For instance, AHN is preparing to roll out an inpatient virtual nursing program that involves generative AI. When the program is launched, AHN’s nurses will be trained on how to carefully explain the new technology-enabled care model to patients.

The nurses’ training will prepare them to communicate that they are still present and active members of the patient’s care team, Barad explained. He said the central message of these conversations should let patients know that nurses aren’t being replaced, but rather given tools to help them better care for patients.

Emphasize data protections and ask for consent

Another important way to build consumers’ trust in generative AI is to be transparent about the data these models are trained on.

AHN recently rolled out a new generative AI tool called Sidekick, which can be thought of as the health system’s own version of ChatGPT. The tool is available to all of AHN’s 22,000 employees, as well as all 44,000 employees employed by its parent company Highmark Health. It was trained solely on AHN’s and Highmark’s own data, Barad noted.

The fact that AHN and Highmark jointly developed their own tool using data specific to their patient populations should make people feel much more comfortable than if AHN were to use an AI tool trained on general data, he explained.

Some generative AI use cases may require express consent from the patient before deployed. Ambient listening tools during a physician-patient visit are a key example of this.

These tools — made by companies such as Nuance, DeepScribe and Abridge — listen to and record patient-provider interactions so they can automatically generate a draft of a clinical note. Like many other health systems across the country, AHN is using ambient documentation technology and asking patients for their consent before each visit, Barad said.

When talking to patients about these AI models, clinicians explain that the tools are designed to prevent them from having to type throughout the entire visit, therefore giving them more time to maintain eye-contact with patients and be present.

The industry may need to collaborate to establish patient education standards

AHN’s neighbour health system, UPMC, is also using ambient documentation technology and requires verbal consent before the tool is deployed during an appointment. This is a use case that clearly necessitates patient consent since they are being recorded. But there is no industry standard.

For example, Deloitte’s report suggested that in coming years, hospitals may start putting disclaimers on clinical recommendations that were produced with the assistance of generative AI. There is no industry standard to let hospitals know when that is necessary and when it’s not, Bart pointed out.

Conclusion

The healthcare industry may need to start establishing standardized protocols for patient education around generative AI use sooner rather than later — because utilization of this technology is only going to grow.

Artificial intelligence-enabled physician will be better able to make the best decisions for patients than those who are naive to artificial intelligence in the future.

Nurses’ and doctors’ training, explain how AI is being used to enhance care, transparent about the data, to be clear about the specific use cases and a  transparent conversation can help to create trust and acceptance.

You like to read more about, please have a look at the full article from MedCityNews: https://medcitynews.com/2024/06/generative-ai-trust-healthcare/

Thaumatec Knowledge Guide | What is the European Health Data Space (EHDS)?

The aim of the EHDS is to make it easier to access and exchange health data across borders, both to support healthcare delivery (‘primary use of data’) and inform health research and policy-making (re-use of data, also referred to as ‘secondary use of data’).

The European Health Data Space (EHDS) will be a key pillar of the strong European Health Union and is the first common EU data space in a specific area to emerge from the European strategy for data. In spring 2024, the European Parliament and the Council reached a political agreement on the Commission proposal for the EHDS.

The EHDS will:

  1. Empower individuals to take control of their health data and facilitate the exchange of data for the delivery of healthcare across the EU (primary use of data)
  2. foster a genuine single market for electronic health record systems
  3. provide a consistent, trustworthy, and efficient system for reusing health data for research, innovation, policy-making, and regulatory activities (secondary use of data)

The EHDS will enable the EU to fully benefit from the potential offered by a safe and secure exchange, use and reuse of health data to benefit patients, researchers, innovators, and regulators.

Trust is a fundamental enabler for the success of the European Health Data Space. EHDS will provide a trustworthy setting for secure access to and processing a wide range of health data.

As horizontal frameworks, they provide rules that apply to the health sector. However, the European Health Data Space will provide specific sectoral rules, considering the sensitivity of health data.

The EHDS will also include opt-out rules for:

  • Primary use, Member States can offer a complete opt-out from the infrastructures to be built under the EHDS;
  • Secondary use, the text includes rules on opting out that build a good balance between respecting patients’ wishes and ensuring that the right data is available to the right people for the public interest.

Building the European Health Data Space will require significant development work.

Commission supports these efforts by co-financing projects such as:

  • the HealthData@EU pilot project
  • the Xt-EHR Joint Action, providing direct grants to Member States
  • building on existing infrastructures

Here some more information provided by the European Commission:

https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en#more-information

https://ec.europa.eu/commission/presscorner/detail/en/QANDA_24_2251

https://health.ec.europa.eu/publications/factsheet-european-health-data-space_en

And a related article:

https://www.euractiv.com/topics/ehds

THAUMATEC KNOWLEDGE GUIDE | How does Vagus Nerve Stimulation work?

The vagus nerve is one of 12 pairs of cranial nerves that originate in the brain and is part of the autonomic nervous system, which controls involuntary body functions. The nerve passes through the neck as it travels between the chest and abdomen and the lower part of the brain. It is connected to motor functions in the voice box, diaphragm, stomach and heart and sensory functions in the ears and tongue. It is connected to both motor and sensory functions in the sinuses and esophagus.

Vagus nerve stimulation (VNS)

VNS sends regular, mild pulses of electrical energy to the brain via the vagus nerve, through a device that is similar to a pacemaker.

There is no physical involvement of the brain in this surgery and patients cannot generally feel the pulses. It is important to keep in mind that VNS is a treatment option limited to select individuals with epilepsy or treatment-resistant depression.

Individuals with any of the following criteria may potentially be unsuitable candidates for VNS:

  • One vagus nerve
  • Receiving other concurrent forms of brain stimulation
  • Heart arrhythmias or other heart abnormalities
  • Dysautonomias (abnormal functioning of the autonomic nervous system)
  • Lung diseases or disorders (shortness of breath, asthma, etc.)
  • Ulcers (gastric, duodenal, etc.)
  • Vasovagal syncope (fainting)
  • Pre-existing hoarseness

VNS Implantation

This procedure, performed by a neurosurgeon, usually takes about 45-90 minutes with the patient most commonly under general anaesthesia. It is usually performed on an outpatient basis. As with all surgeries, there is a small risk of infection. Other surgical risks of VNS include inflammation or pain at the incision site, damage to nearby nerves and nerve constriction.

The procedure requires two small incisions.

  1. One is made on the upper left side of the chest where the pulse generator is implanted
  2. Second incision is made horizontally on the left side of the lower neck, along a crease of skin. This is where the thin, flexible wires that connect the pulse generator to the vagus nerve are inserted.

The device or implant

is a flat, round piece of metal that measures about an inch and a half (4 centimeters) across and 10-13 mm thick, depending on the model used (Pulse Generator, Figure 1). Newer models may be somewhat smaller.

The stimulator contains a battery, which can last from one to 15 years. When the battery is low, the stimulator is replaced with a less invasive procedure which requires only opening the chest wall incision.

The stimulator

is most commonly activated two to four weeks after implantation, although in some cases it may be activated in the operating room at the time of implantation. The treating neurologist programs the stimulator in his or her office with a small hand-held computer, programming software and a programming wand. The strength and duration of the electrical impulses are programmed.

Patients are provided with a handheld magnet

All maneuvers performed with the magnet can be done by the patient, family members, friends or caregivers.

Side effects are most commonly related to stimulation and usually improve over time.

Of these, hoarseness, coughing, throat tickling and shortness of breath are the most common and are usually temporary.

Patient Tips/Guidelines

If you have received VNS, you should monitor your condition and overall health closely. If any of the following occur, call your doctor right away:

  • Constantly hoarse voice
  • Stimulation which becomes painful or irregular
  • Stimulation which causes choking, breathing or swallowing difficulties or a change in heart rate
  • Changes in your level of consciousness, such as increased drowsiness
  • Signs that the pulse generator may not be stimulating properly or that the battery is depleted (the device stops working)
  • Any new or unusual changes related specifically to the stimulation

In addition, you should call your physician before you undergo any medical tests that might affect, or be affected by VNS, such as magnetic resonance imaging (MRI), or before you have any other medical devices implanted.

Epilepsy

The goal of VNS is to reduce the number, length and severity of seizures. VNS may also reduce the time it takes to recover after a seizure. However, VNS is not successful in all patients. The success of this treatment differs — some patients report less frequent seizures, others report a slight reduction, while some patients do not respond at all.

Treatment-Resistant Depression

Soon after VNS was approved by the FDA as a seizure treatment, reports indicated a possible decrease in depression symptoms in patients who had the device implanted for seizure control. Like electroconvulsive therapy, VNS is believed to work by using electricity to influence the production of brain chemicals called neurotransmitters. Depression has been tied to an imbalance in those chemicals.

VNS should not be considered in patients presenting with any of the following:

  • Acute suicidal thoughts or behavior
  • History of schizophrenia, schizoaffective disorder or delusional disorders
  • History of rapid cycling bipolar disorder

There is much controversy on the efficacy of VNS as a treatment for TRD and at this stage, more outcomes data is in progress. Currently, VNS is not a covered benefit of most insurers for TRD. However, depending on the results of pending studies it may once again reach the point of insurance coverage.

To get more insight please have a look into the article of AANS (American Association of Neurogical Surgeons):

https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Vagus-Nerve-Stimulation

Thaumatec HealthTech Industry Update | 7 Major Medtech Trends

7 trends will shape the future of the medical technology space. According to Statista, the Medtech market is worth approximately $691.5 billion. By 2028, the market is expected to reach $23.25 billion, growing at a CAGR of 3.6%. From telemedicine to 3D bioprinting the list of medtech trends creating new opportunities in this dynamic industry.

1. Growing Consumer Adoption Of Telemedicine

COVID-19 caused massive changes in consumer behavior. And the healthcare space is no exception. Based on a survey by McKinsey, only 11% of US consumers were using telehealth services in 2019. Today, thanks largely to COVID-19, that number has grown to 46%.

Searches for “telemedicine” spiked in the spring of 2020. But remains above pre-COVID levels (91% growth in 10 years). And looks like telemedicine is a medtech trend that will continue even as things get back to normal. In fact, 76% of US consumers report that they are interested in using telehealth in the future as a way to complement in-person visits to the doctor.

With a forecast CAGR of more than 23% from 2020-2026, VCs have been especially interested in the telehealth sector. According to Mercom Capital, telemedicine startups received close to $1.8 billion in VC funding in 2019. And in a single 9 month-period of 2020 alone VCs invested $3.2 billion in companies in the telemedicine space.

2. Artificial Intelligence Augments Healthcare Processes

According to CB Insights research, healthcare AI funding reached $3.7 billion in Q3 2020 across 232 deals. The FDA has largely embraced artificial intelligence. Specifically, they currently have several ongoing projects designed to develop and update regulatory frameworks specific to AI.

The FDA are updating regulations to reflect advances in AI. In early 2020, there had been 64 AI/ML-based, FDA-approved medical devices and algorithms. By mid-2023, this figure had increased to over 500. Based on Deloitte’s European study with MedTech Europe, the economic impact of AI applications in healthcare can be quantified as €200 billion in annual savings (including opportunity costs) for the European healthcare system.

There are multiple types of AI applications in healthcare, including:

  • Robotics
  • Personalized apps
  • Labs
  • Monitoring
  • Data analysis
  • Virtual health assistance
  • Wearables

However, medical diagnostics in particular may have the most potential for AI tech. In fact, there are already commercial applications available today. According to an IDTechEx report, image recognition AI technology in medical diagnostics will be worth more than $3 billion by 2030. One of the companies utilizing artificial intelligence in medical diagnostics is Qlarity Imaging.

3. Medical Robots Continue To Gain Traction

According to a Verified Market Research report, the worldwide market size of medical robots is expected to reach $35.05 billion by 2030. Surgical robots are by far the leading category among robotics used in healthcare. And demand for surgical robot technology has seen immense growth in the last few years. Investments in robotic surgery companies have been one of the key drivers of VC funding increase in the medical devices category.

That’s despite a significant decrease in the number of elective surgeries completed due to the pandemic. Moreover, many experts claim the use of robotic technology is especially useful during COVID-19 as it helps to decrease human-to-human physical contact.

4. Heightened Interest In Digital Therapeutics

According to Digital Therapeutics Alliances, “digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high-quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions”.

Thanks to new technical developments and increased consumer adoption of digital health products, DTx (as a part of the broader digital medicine category) has been featured in a recent edition of Scientific American’s top 10 emerging technologies.

Global VC DTx funding has grown by 4x since 2017 to approximately $1.2 billion in 2022. In total, the DTx space has a forecast CAGR of 31.6% during 2021-2026 and a market size of close to $17.7 billion in 2027. In a survey of medtech leaders by Deloitte, 63% of respondents agreed that digital therapeutics will have a major impact on the industry over the next 10 years.

One of the notable players in this sector is Boston-based startup Pear Therapeutics.

5. More Virtual Reality Healthcare Applications

Virtual reality (VR) technology can benefit the healthcare industry in a number of ways, including:

  • Medical training
  • Patient treatment
  • Medical marketing
  • Disease awareness

According to a Verified Market Research report, the VR healthcare market was valued at $2.14 billion in 2019. And is forecast to reach $33.72 billion by 2027. VR startups in the healthcare category have attracted attention from major players.

6. Use Of Biometric Devices And Wearables Is Growing

Products like the Apple Watch, which is still growing, helped create initial awareness of ongoing health tracking. And largely led to the mass adoption of wearable technology.

Today, a growing number of medtech companies are creating a slew of devices to track metrics ranging from physical activity to women’s health.

All of which form the Internet of Medical Things (IoMT). According to a Jabil Digital Health Survey Report, 52% of digital healthcare decision-makers are developing or plan to develop wearable devices. The wearable tech industry is projected to see a CAGR of over 25% from 2020-2027 and  estimates the wearable market will reach upwards of $60.4 billion by 2027.

7. Additive Manufacturing And 3D Bioprinting Gain Steam

Additive manufacturing (commonly referred to as “3D printing”) of medical devices was valued at $1.1 billion in 2019 and is estimated to reach close to $4 billion by 2027. This growth is largely driven by technological advances in the area of 3D printing.

There are multiple use cases of 3D printing in the medical field (including manufacturing of surgical instruments, prosthetics, implants, and tissue engineering products).

However, 3D printing is commonly used for rapid prototyping. In fact, nearly all of the 50 leading medical device companies currently use 3D printing technology to quickly create prototypes.

Amid the COVID-19 pandemic, 3D printing saw a wave of increased demand in the healthcare space.Mostly due to supply chain disruptions and the need to produce greater numbers of PPE, testing, and medical devices to combat COVID-19.

Another concept that is gaining growth in market size is 3D bioprinting. 3D bioprinting is similar to regular 3D printing, but it’s specifically designed to print biological materials.

Conclusion

We hope you learned something new from this list of 7 medical technology trends for 2024-2028. The pandemic boosted consumer adoption of many innovative technologies and highlighted the importance of adaptability in the medical space. So we can expect to see even more medtech innovation in 2024 and beyond.

For more Details have a look at the Article by Josh Howarth in EXPLODING TOPICS:

https://explodingtopics.com/blog/medtech-trends

Thaumatec HealtTech Industry Update | 5 ways AI could improve the world

‘We can cure all diseases, stabilise our climate, halt poverty’ !  It is not yet clear how the power and possibilities of AI will play out. Here are the best-case scenarios for how it might help us develop new drugs, give up dull jobs and live long, healthy lives.

Recent advances such as Open AI’s GPT-4 chatbot have awakened the world to how sophisticated artificial intelligence has become and how rapidly the field is advancing. Could this powerful new technology help save the world?

1. ‘More intelligence will lead to better everything’

Everything’s going to improve. We will be able to cure cancer and heart disease, and so on, using simulated biology – and extend our lives.

The average life expectancy:

  • it was 30 in 1800
  • it was 48 in 1900
  • it’s now pushing 80
  • and we may reach “longevity escape velocity” by 2029.

 If the wrong people take control of AI, that could be bad for the rest of us, so we really need to keep pace with that, which we are doing. But we already have things that have nothing to do with AI, such as atomic weapons, that could destroy everyone. So it’s not really making life more dangerous. And, it can actually give us some tools to prevent people from harming us.

We’ve made great progress but there are still people who are desperate. More intelligence will lead to better everything. We will have the possibility of everybody having a very good life.

2. ‘We can use AI tools right now to help fight climate change’

Everyone wants a silver bullet to solve climate change; unfortunately there isn’t one. But there are lots of ways AI can help fight climate change. While there is no single big thing that AI will do, there are many medium-sized things.

The first role AI can play in climate action is distilling raw data into useful information:  taking big datasets, which would take too much time for a human to process, and pulling information out in real time to guide policy or private-sector action.

The second role is optimisation of complicated systems: such as the heating and cooling system in a building, where there are many controls that an algorithm can operate efficiently. Many companies are improving energy efficiency, and there is a lot of progress still to be made, especially in industries such as steel and cement.

The third theme is forecasting: AI can’t predict something big-picture like what’s going to happen to the economy e.g. what power is going to be available based on the sun and the wind, forecasting how a storm is going to move, or the productivity of crops based upon the weather.

The fourth theme is in speeding up scientific simulations: such as in climate and weather modelling.

Thinking of AI as a futuristic tool that will lead to immeasurable good or harm is a distraction from the ways we are using it now

3. ‘There is going to be an amazing revolution in healthcare’

There is a rapid transformation in the pharmaceutical industry and university research, where they’re shifting to the use of AI to help discover new molecules and new drugs that would have fewer side-effects, and that would help us cure diseases that currently we don’t know how to cure, including cancer, potentially.

One reason AI can be useful here is that the body is very complicated. Even a single cell is extremely complicated: you have 20,000 genes, and they all interact with each other. Biotechnology has progressed to the point where we can measure all the genes’ activity in a single cell at once. While we collect huge quantities of data, the quantity of data is so large that humans are unable to read it. But because machines can, they are able to build models of how your cells work, and how they could be changing under different circumstances that cause disease. So, you can see what happens if you make an intervention; if you introduce a pollutant or a drug, what will be the effect?

This is not just something happening in academia. There are now dozens of startups that have been created at the intersection of AI and drug discovery, broadly speaking. These have been injected with billions of dollars, while pharmaceutical companies are beefing up their machine-learning departments.

4. ‘AI could radically accelerate the process of technological progress itself’

If we figured out how people are going to share in the wealth that AI unlocks, then I think we could end up in a world where people don’t have to work to eat, and are instead taking on projects because they are meaningful to them. E.g. Children do a lot of things because they enjoy them, and not just because they’re the best person in the world at them. They paint and draw, and they have a lot of fun; I paint and draw, and I have a lot of fun, even though [AI image generator] Midjourney is way better at making pictures than me. Similarly, since the 90s, we have had computer programs that can beat humans at chess, but lots of people still play chess.

If you have intelligent AI systems that are accessible to people, it’s as if everybody has access to an infinitely patient teacher so you could imagine training these AI systems to be an interface between humans and other humans.

5. ‘We can flourish, not just for the next election cycle, but for billions of years’

The positive, optimistic scenario is that we responsibly develop superintelligence in a way that allows us to control it and benefit from it. The “control” part is, I think, more hopeful than many people assume. There is a field of computer science called formal verification, where you come up with a rigorous mathematical proof that a program is always going to do what it’s supposed to. You can even create what is called “proof-carrying code”; it works in the opposite way to a virus checker. If a virus checker can prove that the code you are going to run is malicious, it won’t run it; with proof-carrying code, only if the code can prove that it’s going to do what you want it to do will your hardware run it. This is the type of mechanism we need to ensure advanced AI is safe.

We can’t do this yet with GPT-4 or other powerful AI systems, because those systems are not written in a human programming language; they are a giant artificial neural network, and we have almost no clue how they work. But there is a very active research field called mechanistic interpretability.

The goal is to take these black-box neural networks and figure out how they work. If this field makes so much progress that we can use AI itself to extract out the knowledge from other AI and see what it has learned, we could then reimplement it in some other kind of computational architecture – some sort of proof-carrying code – that you can trust. Then you can still use the power of neural networks to discover and learn, but now you can trust something that’s way smarter than you. Then what are we going to do with it?

The sky’s the limit.

Conclusion

We can cure all diseases, stabilise our climate, eliminate poverty, etc. We can flourish not just for the next election cycle, but for billions of years. We have been on this planet for more than 100,000 years, and most of the time we have been like a leaf blowing around in the wind, without much control of our destiny, just trying to not starve or get eaten. Science and technology and human intelligence have made us the captains of our own ship. If we can build and control superintelligence, we can quickly go from being limited by our own stupidity to being limited by the laws of physics.

It could be the greatest empowerment moment in human history.

Take a look at the article of The Guardian: https://www.theguardian.com/technology/2023/jul/06/ai-artificial-intelligence-world-diseases-climate-scenarios-experts

Thaumatec HealthTech Industry Update | FDA qualifies Apple Watch

FDA qualifies Apple Watch AFib feature for use in clinical trials.
Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices.

Overwiew:

  • The Food and Drug Administration has qualified Apple Watch’s atrial fibrillation (AFib) history feature for use in medical device clinical trials, the agency said Wednesday.
  • FDA officials will accept data collected by Apple Watch as a secondary endpoint to help assess AFib burden in studies of cardiac ablation devices. 
  • The FDA said Apple Watch can address challenges related to patient compliance, potential placebo effects and the technical difficulties of measuring AFib burden without an implantable device.

FDA Medical Device Development Tools program

The FDA created the Medical Device Development Tools (MDDT) program to reduce uncertainty in device development. Previously, the agency evaluated tools used to collect data in medical device trials on a case-by-case basis. Through MDDT, the FDA has created a portfolio of qualified tools that sponsors know the agency will accept without needing to reconfirm their suitability for use in a study.

Apple applied with AFib

Apple applied to get its AFib history feature qualified as a MDDT in December. It is the first digital health technology qualified under the program. Apple Watch monitors changes in blood flow at the wrist and measures the intervals between heart beats. The history feature analyzes the intervals to estimate the amount of time the wearer spent in AFib over the previous week.

Qualifying Apple Watch may reduce the burden on a medical device developer, by eliminating the need to provide a rationale for its collection methods and cadence. The Apple Watch could reduce the barrier to assessing AFib burden in device trials.

The FDA said performance may be reduced in patients who have undergone prior ablation and noted the lack of AFib episode timestamps.

See the full article by MEDTECHDIVE

https://www.medtechdive.com/news/fda-apple-watch-atrial-fibrillation-medical-device-development-tool/715210

Apple’s technology for monitoring heart rhythms is at the center of a dispute with Alivecor. A federal judge dismissed an Alivecor lawsuit in February, but the company said it would appeal the ruling.

See as well Reuters:

https://www.reuters.com/legal/apple-beats-alivecor-lawsuit-over-heart-rate-apps-apple-watch-2024-02-07

HealthTech Industry Update | Prioritizing Patient Care

The MedTech industry is poised for breakthroughs, owing to the rapid integration of digital ecosystems and technologies like AI and cloud.

2023 was a banner year for MedTech, especially in terms of technological innovations. Incidentally, it also witnessed the largest ever number of FDA approvals on novel medical devices in a single year. This list included a number of AI-enabled MedTech products, among others.

Nurturing tomorrow: Redefining patient experiences

As the market evolves, MedTech firms are pressed to keep up with the changes afoot for competitive edge and business growth. The early mover advantage will be a crucial factor here as the heat intensifies.

Three key areas are continuing to shape the industry:

⚕ IoMT for connected care

The Internet of Medical Things (IoMT) is a transformative technology that allows healthcare providers to deliver remote care using connected medical devices and software that transmits patient results online.

IoMT allows physicians and experts to analyse data in real-time to provide optimized patient care through informed decision-making and timely interventions. This is especially true in today’s scenario, where chronic diseases are straining already limited medical staff and resources.

⚕ AI, the better care ally

AI, and more recently GenAI, presents a plethora of opportunities in medical imaging and chronic disease management. Here, data is the key.

For instance, several medical players are integrating AI systems with medical devices such as colonoscopy equipment to scan every image taken during the procedure in milliseconds, flagging potential lesions. The AI system can sift through tremendous amounts of data to provide insight-driven care and significantly improve the chances of early detection of colorectal cancer. This is just one example of AI transforming healthcare by empowering MedTech advancements.

⚕ Digital platforms for accessible care delivery

Patient care has reached beyond the four walls of the hospital. Through continuous monitoring, virtual hospital wards and e-clinics powered by wearables, AI-powered cloud platforms, AR/VR, and connected devices are set to reduce in-patient visits.

Digitally equipped platforms like this can be used by hospitals, critical care centres, and rehabilitation centres to tackle a wide range of mental, physical, and occupational health challenges, including chronic pain, anxiety, fibromyalgia, and even dementia.

Conclusions

As the MedTech industry enters the next phase of digital evolution, it’s important to diversify the perspective – and think of accelerators like GenAI, cloud, and IoMT as tools for enhancing patient care and engagement. This will also aid providers and payers, who will now benefit from intelligent workflows, connected data streams, and preventive interventions, ultimately reducing costs and administrative burdens.

The digital transformation of MedTech will result in improved collaboration between stakeholders, paving the way for an interoperable and patient-centric ecosystem.

Here the full Article by the World Economic Forum:

https://medcitynews.com/2024/05/prioritizing-patient-care-medical-technology-innovations-on-the-horizon/

HealthTech Industry Update | AI-enhanced ultrasound for women’s health

Ultrasound is used in many different fields. Ultrasonic devices are used to detect objects and measure distances. Ultrasound imaging or sonography is most often used in medicine. In the non-destructive testing of products and structures, ultrasound is used to detect invisible flaws. Industrially, ultrasound is used for cleaning, mixing, and accelerating chemical processes.

Diagnostic ultrasound is a non-invasive diagnostic technique used to image inside the body. Ultrasound probes, called transducers, produce sound waves that have frequencies above the threshold of human hearing (above 20KHz), but most transducers in current use operate at much higher frequencies (in the megahertz (MHz) range). Most diagnostic ultrasound probes are placed on the skin. However, to optimize image quality, probes may be placed inside the body via the gastrointestinal tract, vagina, or blood vessels. In addition, ultrasound is sometimes used during surgery by placing a sterile probe into the area being operated on.  

  • Diagnostic ultrasound can be further sub-divided into anatomical and functional ultrasound.
  • Anatomical ultrasound produces images of internal organs or other structures.
  • Functional ultrasound combines information such as the movement and velocity of tissue or blood, softness or hardness of tissue, and other physical characteristics, with anatomical images to create “information maps.”

These maps help doctors visualize changes/differences in function within a structure or organ.

Here more information and background:

https://www.nibib.nih.gov/science-education/science-topics/ultrasound

Examples for ultrasound examination in the Femtech area:

Obstetric ultrasonography, or prenatal ultrasound, is the use of medical ultrasonography in pregnancy, in which sound waves are used to create real-time visual images of the developing embryo or fetus in the uterus (womb). The procedure is a standard part of prenatal care in many countries, as it can provide a variety of information about the health of the mother, the timing and progress of the pregnancy, and the health and development of the embryo or fetus.

Breast ultrasound is a medical imaging technique that uses medical ultrasonography to perform imaging of the breast. It can be performed for either diagnostic or screening purposes[1] and can be used with or without a mammogram. In particular, breast ultrasound may be useful for younger women who have denser fibrous breast tissue that may make mammograms more challenging to interpret.

Vaginal ultrasonography is a medical ultrasonography that applies an ultrasound transducer (or “probe”) in the vagina to visualize organs within the pelvic cavity. It is also called transvaginal ultrasonography because the ultrasound waves go across the vaginal wall to study tissues beyond it.

Ovarian cysts are usually diagnosed by ultrasound, CT scan, or MRI, and correlated with clinical presentation and endocrinologic tests as appropriate.

Pelvic congestion syndrome, also known as pelvic vein incompetence, is a long-term condition believed to be due to enlarged veins in the lower abdomen. The condition may cause chronic pain, such as a constant dull ache, which can be worsened by standing or sex. Pain in the legs or lower back may also occur.

Current advances of Ultrasound in the Femtech area:

GE HealthCare designed the ultrasound systems to integrate AI, advanced tools and an ergonomic design. They speed exam time for clinicians while delivering a clearer picture of various conditions impacting women’s health. The latest systems combine high-performance hardware with flexible, scalable software to help increase confidence in diagnostic and treatment decisions.

AI-enabled ultrasound technologies support clear, quick and confident diagnoses. This latest launch helps to address patient demand and reduce staffing burdens by giving clinicians these tools.

New, improved and enhanced Features are:

  • Features include voice commands and the SonoLyst suite of AI tools. SonoLyst tools identify fetal anatomy and annotate and measure where applicable. This can reduce the time to complete second trimester exams.
  • simplifies assessments of the pelvic floor and speeds up exams as well. It automates plane alignment and measurements for high keystroke reduction.
  • They integrated the technology with its Vscan Air CL wireless dual probe. With a flexible, wireless workflow, users gain a wider range of motion.
  • FetalHS simplifies and speeds fetal heart assessments with step-by-step, AI-driven guidance for identifying normal fetal heart anatomy.

Conclusions and Opinions

  • With proven time-saving AI-driven applications, and advanced automation features that simplify exams, the technology can help enhance ease of use and provide clearer images, helping clinicians power through demanding workflows faster while delivering greater consistency and accuracy, ultimately helping deliver better health outcomes for women.
  • The new Voluson Signature series features innovative tools clinicians can rely on, and the automated functions help reduce work stress and improve workflows
  • A new era of ultrasound scanning.

Here the link to the article of +MASS DEVICE:

https://www.massdevice.com/ge-healthcare-launches-ai-ultrasound-womens-health/

HealthTech Industry Update | Artificial Intelligence in the Medical Imaging Technology

The integration of Artificial Intelligence (AI) into medical imaging has guided in an era of transformation in healthcare.

The innovation segment explores cutting-edge developments in AI, such as deep learning algorithms, convolutional neural networks, and generative adversarial networks, which have significantly improved the accuracy and efficiency of medical image analysis.

Advancements in medical imaging and artificial intelligence (AI) have ushered in a new era of possibilities in the field of healthcare. The fusion of these two domains has revolutionized various aspects of medical practice, ranging from early disease detection and accurate diagnosis to personalized treatment planning and improved patient outcomes.

Medical imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET) play a pivotal role in providing clinicians with detailed and comprehensive visual information about the human body. These imaging modalities generate vast amounts of data that require efficient analysis and interpretation, and this is where AI steps in.

Technological Innovations

Mathematical models and algorithms stand at the forefront of scientific exploration, serving as powerful tools that enable us to unravel complex phenomena, make predictions, and uncover hidden patterns in vast datasets. These essential components of modern research have not only revolutionized our understanding of the natural world but have also played a pivotal role in driving technological breakthroughs that open up numerous application possibilities across various domains.

The synergy between mathematical models and algorithms has not only enhanced our understanding of the world but has also been a driving force behind technological advancements that have transformed our daily lives.

Transformers

Convolutional Neural Networks (CNNs) are well suited for grid-like data, such as images, where local patterns can be captured efficiently. However, they struggle with sequential data because they lack a mechanism for modeling dependencies between distant elements (for example, in distinct time instants or far in the image).

Also, CNNs do not inherently model the position or order of elements within the data. They rely on shared weight filters, which makes them translation invariant but can be problematic when absolute spatial relationships are important.

Generative Models

Generative models are a class of machine learning models that can generate new data based on training data. Other generative models include generative adversarial networks (GANs), variational autoencoders (VAEs), and flow-based models. Each can produce high-quality images.

Deep Learning Techniques and Performance Optimization

Medical imaging techniques are based on different physical principles, each with their benefits and limitations. The ability to deal with such diverse modalities is also an important aspect to be addressed by AI.

Applications

AI-based imaging techniques can be divided in eight distinct categories: acquisition, preprocessing, feature extraction, registration, classification, object localization, segmentation, and visualization. These can also be organized in the clinical process pipeline broadly encompassing prevention, diagnostics, planning, therapy, prognostic, and monitoring. It is also possible to focus on the human organ or physiological process under focus.

Medical Image Analysis for Disease Detection and Diagnosis

Medical image analysis for disease detection and diagnosis is a rapidly evolving field that holds immense potential for improving healthcare outcomes. By harnessing advanced computational techniques and machine learning algorithms, medical professionals are now able to extract invaluable insights from various medical imaging modalities.

Artificial intelligence is an area where great progress has been observed, and the number of techniques applicable to medical image processing has been increasing significantly. In this context of diversity, review articles where different techniques are presented and compared are useful.

The role of AI in facilitating the analysis of large-scale retinal datasets and the development of computer-aided diagnostic systems is also highlighted.

However, AI is not always a perfect solution, and the challenges and limitations of AI-based approaches are also covered, addressing issues related to data availability, model interpretability, and regulatory considerations.

Imaging and Modeling Techniques for Surgical Planning and Intervention

Imaging and 3D modeling techniques, coupled with the power of artificial intelligence (AI), have revolutionized the field of surgical planning and intervention, offering numerous advantages to both patients and healthcare professionals.

By leveraging the capabilities of AI, medical imaging data, such as CT scans and MRI images, can be transformed into detailed three-dimensional models that provide an enhanced understanding of a patient’s anatomy. This newfound precision and depth of information allow surgeons to plan complex procedures with greater accuracy, improving patient outcomes and minimizing risks and AI-powered algorithms can analyse vast amounts of medical data, assisting surgeons in real-time during procedures, guiding them with valuable insights, and enabling personalized surgical interventions.

Image and Model Enhancement for Improved Analysis

Decision-making and diagnosis are important purposes for clinical applications, but AI can also play an important role in other applications of the clinical process.

In complex healthcare scenarios, it is crucial for clinicians and practitioners to understand the reasoning behind AI models’ predictions and recommendations.

Medical images often suffer from noise, artifacts, and limited resolution due to the physical constraints of the imaging devices. Therefore, developing effective and efficient methods for medical image super-resolution is a challenging and promising research topic, searching to obtain previously unachievable details and resolution.

Medical Imaging Datasets

Numerous advancements outlined above have arisen through machine learning public challenges. These initiatives provided supporting materials in the form of datasets (which are often expensive and time consuming to collect) and, at times, baseline algorithms, contributing to the facilitation of various research studies aimed at the development and evaluation of novel algorithms.

Conclusions

Cutting-edge techniques that push the limits of current knowledge have been covered in this editorial. For those focused on the AI aspects of technology, evolutions have been reported in all stages of the medical imaging machine learning pipeline.

The field of medical imaging and AI is evolving rapidly, driven by ongoing research and technological advancements. Researchers are continuously exploring novel algorithms, architectures, and methodologies to further enhance the capabilities of AI in medical imaging. Additionally, collaborations between clinicians, computer scientists, and industry professionals are vital in translating research findings into practical applications that can benefit patients worldwide.

By combining cutting-edge AI techniques and their practical applications, it is clear that AI will continue shaping the future of healthcare in profound and positive ways.

Here the link to the full article in Bioengineering (Basel) from Luís Pinto-Coelho

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10740686

Thaumatec HealthTech Industry Update | How Can Healthcare Ensure Responsible AI Use?

Executives from across the industry shared their thoughts on how the healthcare sector can ensure its use of AI is ethical and responsible during the HIMSS24 conference, which took place in Orlando. Below are some of the most notable ideas they shared.

Collaboration is a must

While the healthcare industry lacks a shared definition for what responsible AI use looks like, there are plenty of health systems, start-ups and other healthcare organizations that have their own set of rules to guide their ethical AI strategy. Healthcare organizations from all corners of the industry must come together and bring these frameworks to the table in order to come to a shared consensus for the industry as a whole, he explained.

Start with use cases that have low risks and high rewards

Currently, there are still many unknowns when it comes to some of the new large language models hitting the market. That is why it is essential for healthcare organizations to begin deploying generative AI models in areas that pose low risks and high rewards. Using generative AI to generate a summary of a patient’s hospital stay and prior medical history isn’t very risky, but it can save nurses a lot of time and therefore be an important tool for combating burnout.

Trust is key

Generative AI tools can only be successful in healthcare if their users have trust in them. Because of this, AI developers should make sure that their tools offer explain-ability. For example, if a tool generates patient summaries based on medical records and radiology data, the summaries should link back to the original documents and data sources. That way, users can see where the information came from.

Conclusions

Healthcare leaders “sometimes expect that the technology will do more than it is actually able to do”  but  AI is not a silver bullet for healthcare’s problems.  To not get stuck in this trap, think of AI as something that serves a supplementary or augmenting function. AI can be a part of the solution to major problems like clinical burnout or revenue cycle challenges, but it’s unwise to think AI will eliminate these issues by itself.

Here the full Article by MedCity News:

https://medcitynews.com/2024/04/healthcare-ai-2/

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