New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new ...

Intuitive is buying businesses that distribute its da Vinci and Ion surgical robots to establish a direct presence in Italy, ...

The surgical robot leader is watching developments under the new administration but has not included any tariff impact in its ...

Johnson & Johnson executives, on a Wednesday earnings call, did not provide a timeline for when U.S. Varipulse cases will ...

A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...

Szyman led Edwards Lifesciences’ critical care unit for more than a decade before BD acquired the group last year. Her ...

Piéton fills an opening left by Karen Parkhill, who became HP’s CFO in August after eight years with Medtronic.

The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for ...

The rescinded orders include directives boosting the Affordable Care Act exchanges, coordinating the government’s COVID-19 ...

Medtronic will be the exclusive U.S. distributor of Contego Medical’s portfolio, which includes a carotid stent system and ...

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