FDA

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.

In a statement, Dr. Scott Gottlieb detailed his agency’s ongoing cybersecurity efforts, which include the signing of two “significant memoranda of understanding” and discussions to facilitate collaboration across government agencies.

A robust investigation published in Diabetes Care looked at 18 top-selling meters, making up 90 percent of the market.

The results to our poll about the FDA program prompt questions about the program's fairness to companies big and small.

The announcement has drawn questions about novelty and claims of coziness with the FDA.