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AHA Center for Health Innovation Market Scan
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4 Steps to Improve Medical Device Recall Tracking

As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
News

FDA finalizes recommendations simplifying approval process for medical devices that use AI

The Food and Drug Administration yesterday released recommendations for streamlining the approval process
News

FDA clarifies definition of 'remanufacturing' for medical devices needing maintenance

The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devic