FDA
The Verily Study Watch is a prescription-only wearable that can record, store, transfer and display single-channel ECG rhythms.
The clearance is a first for the relatively underserved epilepsy wearable space.
Tivic Health Systems’ ClearUP Sinus Pain Relief uses low current electrical waves to stimulate nerves beneath the skin.
Ongoing FDA submissions and other HHS services are safe, but new regulatory filings will have to be put on hold.
The prescription device detects each use and records it to a paired mobile app.
The regulatory changes also come alongside Pre-Cert Program updates and roughly a dozen noteworthy digital health approvals.
The HeartGuide watch uses a flexible synthetic band to inflate and maintain its shape to comfortably take an oscillometric wrist blood pressure on the fly.
Also: Livongo names Zane Burke as the next CEO; Atrium Health taps Dr. Rasu Shrestha as VP and chief strategy officer.
Comprised of a Samsung touch screen device and an app-based platfrom, the InterStim smart programmer helps patients and physicians more easily monitor incontinence implants.
Also: Literature review finds telehealth treatments to be on par with in-person care; Survey finds consumers' interest in wearables for health tracking grows.