Lobby groups like AdvaMed and the American Hospital Association have so far failed to get medical devices and critical ...

Medtronic, Abbott and Boston Scientific provided updates on their devices used in heart valve disease treatment at the event.

Teams working on communications and policy were cut from the agency on Tuesday, according to multiple FDA workers interviewed ...

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed ...

The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...

With PFA becoming physicians’ preferred ablation method for treating AFib, Abbott is pushing to catch up with rival systems ...

Sales of Beta Bionics insulin pumps spiked 145% in the fourth quarter behind solid new patient starts. Elsewhere, former ...

Complaints provide insights to improve product quality, ensure compliance, and drive growth. Cardinal Health is transforming ...

CMO Jordan Pinsker said Tandem hopes to expand Medicare coverage of its automated insulin delivery systems with results of a ...

Visby Medical’s at-home diagnostic, which can be purchased without a prescription, tests for chlamydia, gonorrhea and trichomoniasis.

Dexcom pushed back on claims in a Food and Drug Administration warning letter that the company made unauthorized changes to its glucose sensors. Company spokesperson Nadia Conard wrote in an email ...