We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

The FDA has approved Valcare Medical’s IDE application, allowing it to begin an EFS of Amend Trans-Septal System.

In Thursday's meeting, the director of the FDA's Center for Drug Evaluation and Research said plans for coming layoffs were ...

The Committee pointed out that several medical device manufacturers are hesitant to set up units in India due to the delaying ...

Class II recalls — a grade below the most serious Class I recalls — reference a situation in which the use of or exposure to ...

Proving your product to be safe and effective while also getting buy-in from the healthcare ecosystem are only some of the ...

Lifeward announced today that it received FDA 510(k) clearance for its latest-generation personal exoskeleton device, ReWalk ...

Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks. Here are some of the latest recalls reported to the FDA: ...

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...

Last week, Lifeward said full-year revenue rose to $25.7 million from $13.9 million. It said ReWalk Personal Exoskeleton sales increased by 130% in 2024, fueled by recently established Medicare ...

Perfuze, a medtech has raised €22m. With the infusion, the company will release its catheters to select stroke centres in the US.