MobiHealthNews

Medco medication adherence app registered with FDA as Class 1 device

This morning at the FDA's public Workshop on its Mobile Medical Applications Draft Guidance, which it published in July, FDA senior advisor Bakul Patel noted that Medco had registered its smartphone ...
Star Tribune

Medtronic faces FDA Class I recall for post-op drainage device

The U.S. Food and Drug Administration has issued a Class I recall, the agency’s most serious, for a Medtronic device used to temporarily drain spinal fluid from patients after surgery for a thoracic ...
WTNH

Spectral AI’s DeepView SnapShot® Wound Imaging System, Achieves UKCA Mark and FDA Class 1 Medical Device Classification

DALLAS, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster ...
Star Tribune

Yet another FDA Class 1 recall for Minnesota-made infusion syringe pumps

The U.S. Food and Drug Administration (FDA) this week issued a Class I recall — its most serious — for the Medfusion syringe pump, the agency’s third major recall of the line of devices made in ...