FDA
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.
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.
The agency's proposal would classify the majority of software released by pharmas as "promotional labeling" that would not require premarket review.
As AI cements its role in healthcare, more and more intelligent software offerings are pursuing 510(k) and De Novo approvals.
While the company's successful G6 launch was its focus, Dexcom had a busy third quarter for other news as well.
Also: L’Oréal unveils UV sensor clip, companion app; Urinary incontinence wearable receives De Novo clearance.
The AI tool helps clinicians prioritize patients in need of immediate diagnosis, but does not render these decisions on its own.
The clearance brings US readers a feature long available in Europe, and paves the way for data plays.
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.