Patients flocked to those Ozempic, Wegovy copycats when the branded drugs were in short supply, or if they didn’t have ...

Medtronic has submitted 510(k) applications to the U.S. Food and Drug Administration seeking clearance for an interoperable pump.

Proprio, the global leader in AI-powered surgical technology, announced that its AI guidance platform for surgery, Paradigm, has received its second major 510(k) clearance from the US Food and Drug ...

Turbett Surgical's Instrument Pods receive FDA 510(k) clearance, boasting increased weight capacity of up to 300 lbs for the TS1200 and expanded lumen validation for improved surgical instrument ...

Late yesterday, the FDA announced plans to replace animal testing in the development of monoclonal antibody therapies and other drugs with human-relevant methods. The FDA's animal testing requirement ...

The letter from the Department of Education’s Office of Civil Rights to President Christina Paxson P’19 P’MD’20 was far more critical of the University’s response to antisemitism. It detailed numerous ...

The approvable letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the US FDA’s PMA ...

The idea was to preserve some of the FDA’s most important functions. But drug reviews are likely to be affected, anyway, more than a dozen current and recently departed FDA employees told STAT.

Renewall refused, so the utility took the issue to the regulator, which issued a decision on the matter this week. In a letter to Nova Scotia Power, the board said requiring a letter of credit ...

They decided to defer any decision on a letter until they could review provincial legislation and get legal advice. (Julianne Hazlewood/CBC) Region of Waterloo councillors have voted to defer any ...