Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

FDA's IDE approval for UroMems’ UroActive System follows strong feasibility clinical study results in both men and women.

FDA Will Use AI to Approve Drugs and Devices Faster The agency launched a large-language model, dubbed Elsa, just last week to streamline operations.

There is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by Medicare.

BURLINGTON, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- CoreMap today announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to extend ...

Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. Medtronic has a commercialization deal with the company for the device, which ...

How can physicians and patients be confident enough that vendors entirely ignorant of the FDA process for repair and reporting can properly recalibrate life-saving machines? Is this really the ...

The Health Tech Investment Act would establish a reimbursement pathway for FDA-cleared AI-enabled medical devices.

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s ...

The FDA has allowed a substantial amount of late reports and undated reports into its Manufacturer and User Facility Device Experience (MAUDE) safety database, researchers confirmed.

The Food and Drug Administration (FDA) published new guidance for AI-enabled medical devices on January 7, 2025. These are nonbinding and not for implementation. The public comment window for ...