digital health FDA
The company's CEO defended its feature as a wellness tool under the 21st Century Cures Act, combating the FDA’s claim that it qualifies as a regulated medical device.
The company has secured 510(k) clearance for its Apple Watch-powered seizure monitoring platform, expanding the role of wearables in epilepsy care.
The AI-enabled technology detects a lack of pulse, confirms the condition using motion sensors and infrared signals, and automatically alerts emergency services if needed.
Digital Therapeutics Alliance CEO joins FDA Digital Health Advisory Committee and more digital heal…
Arrive AI appoints a former Elevance Health executive to its board, and CareAbout Health hires a seasoned digital health executive to be its new chief technology officer.
This half of the year the FDA has named a new comissioner, continued working on the much anticipated Pre-Cert program and collaborated with the NIH on a new app.
The organization reports it has completed retrospective testing and is in the process of prospective testing.
The technology has a built-in sensor that can send usage data to a corresponding smartphone app.
A collection of 34 approvals and clearances by the US Food and Drug Administration during Q3 and beyond.
The agency has reinvented the process for clearing digital health products but reviews are mixed.