Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.

Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue.

To promote consistency and reliability in analytical chemistry studies for premarket submissions, the FDA shared recommended approaches for device biocompatibility analysis.

Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.

PET radiotracers facilitate the visualization of amyloid plaque density, enabling clinicians to assess people with cognitive impairment for Alzheimer’s and evaluate their response to treatment.

The proxy victory for Politan means the activist investor, with a 9% stake in the company, now controls four of six seats on Masimo’s board of directors. Politan nominees Darlene Solomon and William ...

Some people who use a Freestyle Libre 3 glucose sensor are facing delays getting their prescriptions filled. Abbott spokesperson Lindsy Delco said the delays are driven by strong demand for the Libre ...

A California jury ruled on Wednesday that Axonics did not infringe three of Medtronic’s patents related to sacral neuromodulation. The latest decision resolves a lawsuit that has been ongoing since ...