The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

The pulse oximeter, a device that measures the degree to which red blood cells are saturated with oxygen, is one of healthcare's most fundamental tools.

Regulating drug discovery and pharmaceutical manufacturing, the FDA ensures the safety and effectiveness of innovative ...

FOX 2 - You know what season we're about to enter? The season of sniffling, sneezing and sinus trouble. But now the FDA is ...

Cardiologists from BIDMC, commissioned by the FDA, examined trends in the use and long-term safety of a device for treating ...

NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve ...

announced the US Food and Drug Administration's (FDA) Medical Device Advisory Committee Panel's (the Advisory Panel) favourable recommendation with 9 panelists voting in favour and 5 voting against ...

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...

As of August 2024, the FDA has greenlit a staggering 950 AI– and ML-enabled medical devices. With the surge of connected ...

14, 2024 /PRNewswire/ -- Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that the Center for Devices and ...

Although sales of tobacco products have been restricted in hundreds of municipalities across the US, a new study is ...