ARTICLE SUMMARY:
Apple receives 510(k) clearance for its new Apple Watch Hypertension Notification Feature. Excerpted from Pathways’ Picks September 17: CMS Departure, Apple 510(k) Questions, PCCPs on the Rise, and More.
FDA granted 510(k) clearance to Apple for its new Hypertension Notification Feature (HTNF) on the Apple Watch on September 11, and followed up this week with the posting of the 510(k) summary for the software. A key detail from the summary that caught the attention of regulatory specialists is the predicate device Apple relied on. HTNF, cleared based on a 2,229-patient study and other data, is an over-the-counter tool relying on passive photoplethysmography (PPG) optical monitoring analyzed by AI algorithms to identify patterns suggestive of hypertension and notify the user. The predicate, meanwhile, is the Viz HCM (Viz.ai), which is a prescription, hospital-use device that leverages AI to analyze on-demand 12-lead ECG measurements to detect signs associated with hypertrophic cardiomyopathy. Despite the differences, FDA concludes, the “subject device has been appropriately verified and validated through non-clinical and clinical testing to ensure that the device is substantially equivalent to the predicate.”