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
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.
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