FDA

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.

This is the first FDA clearance for Apple and pushes the Watch further into healthcare than ever before.

The KardiaK Software Platform could be used with mobile ECG devices to identify potential cases of kidney disease.

Epstein Becker & Green's Bradley Merrill Thompson says the FDA's much-touted program is riddled with unseen costs and unanswered questions.