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 ...

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

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

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

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

Abbott has trailed medtech competitors in bringing a PFA device to market, but now plans to accelerate its European rollout in the second half of this year, after beginning with EU physicians familiar ...

Beta Bionics reported its first quarterly results as a public company. Sales jumped 145% to $20.4 million in the fourth quarter, coming in 2% above the consensus estimate of Wall Street analysts, ...

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 ...

A warning letter posted Tuesday by the Food and Drug Administration revealed quality control issues with Dexcom’s continuous glucose monitors. The FDA raised concerns with a design change to a ...

Dr. Mehmet Oz, President Donald Trump’s choice to lead the CMS, is one step closer to securing the job. On Tuesday, the Senate Finance Committee voted 14 to 13 along party lines to advance Oz’s ...