FDA 510(k)
The company has received multiple clearances as it gears up for the release of its next-generation smartphone-connected ECG platform.
Partner AliveCor also got a mysterious new FDA clearance.
The longtime player in the home ECG space may be shoring up to compete with the likes of Apple.
The Verily Study Watch is a prescription-only wearable that can record, store, transfer and display single-channel ECG rhythms.
The regulatory changes also come alongside Pre-Cert Program updates and roughly a dozen noteworthy digital health approvals.
To encourage healthcare technology innovation and update the 510(k) pathway, the regulatory agency said that it will soon release measures aimed to sunset predicate devices that are over a decade old.
While the company's successful G6 launch was its focus, Dexcom had a busy third quarter for other news as well.
The clearance brings US readers a feature long available in Europe, and paves the way for data plays.
The app monitors heart rhythms via the smartphone's camera and uses AI to identify irregularities.