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

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

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 ...

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

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

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

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

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

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

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

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