News

03/10/2025

Thaumatec HealthTech Industry Update | HealthTech advances in pediatric medicine

Kurt Neubauer

Kurt Neubauer

Advances in pediatric medicine and healthtech in 2025 focus on integrating digital technologies, personalized treatments, and innovative care models to improve outcomes and accessibility for children. Key developments include:

  • Telemedicine
  • AI-driven diagnostics and treatment plans
  • robotics-assisted surgery
  • gene therapy,
  • wearable biosensors
  • and hybrid care models combining digital and in-person care.

These technologies enhance precision, reduce risks, and support families and clinicians, especially for chronic or complex conditions in remote or underserved areas.

Here some insight topics:

  • Major Advances in Pediatric Medicine
  • HealthTech Innovations in Pediatric Care
  • Which AI tools assist pediatric diagnosis
  • Which AI tools are FDA cleared for pediatric use
  • List of MDR-cleared AI medical devices for pediatrics

Here more details

Major Advances in Pediatric Medicine

Pediatric research is advancing with gene therapy and biological drugs, which offer new treatment options for previously incurable genetic disorders, immunodeficiencies, tumors, and hematological conditions.

Precision medicine is enabling personalized diagnoses and tailor-made therapies, optimizing drug dosages and treatment efficacy.

Specialized areas like pediatric respiratory and sleep medicine are seeing significant research and clinical progress.

HealthTech Innovations in Pediatric Care

Telemedicine has improved healthcare access for children, especially in remote areas, enabling real-time consultations and remote monitoring.

Robotics enhances surgical precision and reduces recovery time, particularly for minimally invasive surgeries.

AI and machine learning are used to analyze medical data for early detection, personalized treatment plans, and better patient management.

Wearable sensors and mobile platforms provide real-time health data and support symptom tracking, improving care for children with chronic conditions.

Hybrid care models blend digital tools with traditional in-person care, balancing convenience with essential hands-on interaction.

Digital tools also aim to reduce clinicians’ workload and support families, including AI-powered decision support and chatbots for communication.

These advancements mark significant progress in transforming pediatric healthcare to be more personalized, accessible, safer, and efficient, with a strong emphasis on technology integration and innovations tailored to children’s unique needs.

Which AI tools assist pediatric diagnosis

AI tools are significantly advancing pediatric diagnosis and triage through various innovative applications:

AI-driven early warning systems and machine learning (ML) models improve early detection and precision diagnostics for complex pediatric conditions such as brain tumors, congenital heart disease, allergies, and sepsis. These tools analyze multimodal data including bio-signals, genetic, imaging, and environmental inputs to enhance accuracy and timely intervention.

In pediatric emergency departments, AI-based triage systems augment traditional triage by predicting clinical outcomes and hospital admission needs more accurately. Models like random forests and deep learning outperform conventional approaches such as the Emergency Severity Index. AI-driven triage reduces over-triage and wait times, improving resource allocation and patient flow.

Language models such as GPT-4 show promise as decision support tools for pediatric triage, aligning closely with expert clinical judgment to aid triage teams.

AI tools also assist diagnosis by improving interpretation of pediatric imaging (X-rays, MRIs) to identify fractures, tumors, and pneumonia, reducing radiation exposure and repeat imaging need.

Virtual health assistants powered by AI chatbots provide personalized health information and support chronic condition management for children and families.

Specific AI applications include Pediatric Early Warning Score (PEWS) enhancements, risk prediction post heart surgery, and integration of AI in pediatric intensive care units.

These AI-powered tools collectively enhance diagnostic accuracy, optimize emergency triage, support personalized treatment plans, and improve overall clinical efficiency in pediatric healthcare settings.

Examples of FDA cleared AI tools are for pediatric use

FDA-cleared AI tools specifically for pediatric use include the following examples:

Pearl’s Second Opinion® Pediatric, an AI platform for dental radiography, is FDA cleared to assist dentists in detecting caries in pediatric patients as young as 4 years old. It enhances clinical decision-making with AI-powered radiographic analysis for pediatric dental care.

BoneView by Gleamer is the first AI solution FDA-cleared for fracture detection in children and adolescents over 2 years old. It aids radiologists and emergency physicians in accurately diagnosing fractures with high sensitivity, improving patient outcomes.

TechCare Kids is an AI tool designed for detecting bone and chest anomalies in children, providing reliable and reproducible measurements for radiologists.

According to recent reviews, out of the large number of FDA-approved AI medical devices (nearly 250 by 2023), only a small portion (about 17%) are explicitly labeled for pediatric use. Many pediatric-labeled devices lack validation with pediatric data, raising concerns about efficacy and safety for children. Most FDA-cleared AI tools are for radiology, cardiovascular, and neurology applications.

In summary, while the FDA has cleared a limited number of AI tools specifically for pediatric patients, notable examples include Pearl’s dental AI and Gleamer’s BoneView fracture detection, marking important strides in pediatric AI medical technology.

List of MDR-cleared AI medical devices for pediatrics

Here is a list of MDR-cleared AI medical devices with pediatric use or preference based on available regulatory information:

Devices such as CergenX Ltd.’s AI EEG screening and i-ROP DL for retinopathy of prematurity are FDA Breakthrough devices in pediatric prognosis but not fully cleared yet.

This list includes devices cleared under FDA and CE marking, with pediatric indications or validations.

The number of MDR-cleared AI medical devices explicitly labeled for pediatrics remains small but is growing steadily in areas like monitoring, diagnosis, treatment, and prognosis in pediatric care.

SOURCES:

https://www.uk.elsevierhealth.com/advances-in-pediatrics-2025-9780443344558.html

https://www.pedistat.com/blog/the-future-of-pediatric-care

https://pmc.ncbi.nlm.nih.gov/articles/PMC12389387

https://www.contemporarypediatrics.com/view/top-5-pediatric-health-headlines-you-missed-in-september-2025

https://shop.elsevier.com/books/advances-in-pediatrics-2025/berkowitz/978-0-443-34455-8

http://www.rcpch.ac.uk/resources/digital-health-solutions-survey-2024-25-results

https://clinicalpediatric.pediatricsconferences.com/events-list/advances-in-pediatric-medicine

https://publications.aap.org/pediatrics/article/156/Supplement 1/e2025070739L/203521/Using-Artificial-Intelligence-and-Machine-Learning

https://www.sciencedirect.com/journal/advances-in-pediatrics

https://www.innovation4kids.org/wp-content/uploads/2025/01/WHITEPAPER_v3_FINAL.pdf

http://www.rcpch.ac.uk/news-events/events/digital-paediatrics-2025

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