FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The Hypertension Notification Feature (HTNF) is a software-only mobile medical application by Apple that uses AI to analyze pulse sensor data collected by Apple Watch to notify users of possible hypertension. It helps adults over 22 years who are not diagnosed with hypertension to identify potential high blood pressure patterns, guiding them for further evaluation, but it is not a diagnostic or monitoring tool. It is designed for over-the-counter use, providing accessible cardiovascular health insights from wearable technology.

FDA #
K250507
Product Code
SFR
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