The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...
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.
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...
The FDA Modernization Act of 1997 established the Fast Track designation ... to educate and inform site visitors interested ...
As of August 2024, the FDA has greenlit a staggering 950 AI– and ML-enabled medical devices. With the surge of connected ...
NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve ...
Cardiologists from BIDMC, commissioned by the FDA, examined trends in the use and long-term safety of a device for treating ...
The study's authors also found that the absolute number of annual IVCF retrievals remained largely stagnant during that time, ...
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LED device treats leading cause of vision loss with light therapy, FDA saysThe Food and Drug Administration will allow a new device to be marketed as a treatment for dry age-related macular ...
Although sales of tobacco products have been restricted in hundreds of municipalities across the US, a new study is ...
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