digital health FDA
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.
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.
Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort.
Israel-based DarioHealth has been granted 510(k) clearance for a version of its Blood Glucose Monitoring System that, alongside the Dario app, is compatible with iPhone 7, 8, and X, according to a statement from the company.