FDA clearance
Tivic Health Systems’ ClearUP Sinus Pain Relief uses low current electrical waves to stimulate nerves beneath the skin.
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.
The system also has a diabetes coach and tracking system.
According to manufacturer Electrocore, it is the first treatment of any kind to receive the indication.
As AI cements its role in healthcare, more and more intelligent software offerings are pursuing 510(k) and De Novo approvals.
The AI tool helps clinicians prioritize patients in need of immediate diagnosis, but does not render these decisions on its own.
While the test offers information on whether or not certain treatments may be effective, the regulatory agency stressed that the results should never be used in care decisions.
OpenSight, which Novarad claims is the first FDA-cleared preoperative technology to use HoloLens, helps practitioners prepare for operations.
The app monitors heart rhythms via the smartphone's camera and uses AI to identify irregularities.
Maryland-based RightEye now has clearance for its software that helps clinicians assess reading skills, brain health and functional vision.