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 ...

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

Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...

A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...

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

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

Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and ...

Thomas Payne, HCA Healthcare’s national medical director of robotics, explains how the largest U.S. health system is vetting ...

The Johns Hopkins surgeon will helm the agency as layoffs loom and important decisions on treatments for rare and infectious ...

The DNA-testing company plans to sell its assets after the board rejected an acquisition proposal from Wojcicki.

Medical device companies presented new data this week at the Advanced Technologies & Treatments for Diabetes conference.