According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
the company's neurorehabilitation system to support gait rehabilitation and motor function in adults with Parkinson's disease (PD), has been listed as a Class II, Rx-only medical device with the U ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
The FDA says the device, designed to repair broken blood vessels to stem bleeding, showed a “clinically meaningful benefit.” ...
Odor Solution™ will be launched in Q2 2025FDA clearance and MDR certification already securedFirst generation hygh-tec™ catheter rapidly ...
Medical Device Network on MSN8d
FDA tags Medtronic embolisation device recall as Class IMedtronic initiated the recall of certain Pipeline Vantage embolisation devices in January 2025 following reports of four ...
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