FDA
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.
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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.
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The eight devices will receive increased guidance and interaction for their clearance efforts, and some will receive Breakthrough Device designation.
According to manufacturer Electrocore, it is the first treatment of any kind to receive the indication.