FDA

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.

Online patient community PatientsLikeMe, which connects patients with different symptoms and conditions and collects patients' voluntarily submitted data for research, has teamed up with the FDA on a research study that could point the way toward a new channel for patient-generated health data for the agency.

As laid out in the 21st Century Cures Act, the Breakthrough Devices Program looks to streamline new medical technologies that offer improved treatment for serious diseases.