FDA

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. 

A collaborative attitude and a commitment to strenuous review have characterized the process so far.

At today's Healthcare Security Forum in Boston, FDA's Dr. Suzanne Schwartz revealed that patchability forensic data capture will be key components of the agency's soon-to-be-released premarket guidance for medical device cybersecurity. 

The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.