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This morning at the FDA's public Workshop on its Mobile Medical Applications Draft Guidance, which it published in July, FDA senior advisor Bakul Patel noted that Medco had registered its smartphone ...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

FDA Approves First-in-Class Optune Pax Device for Pancreatic Cancer

The FDA approved Optune Pax (Novocure), a first-in-class portable device that delivers tumor-treating fields (TTFields) to ...
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 ...
AOL

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

The U.S. Food and Drug Administration issued a Class I recall, the agency's most serious, for the Medfusion syringe pump, the third major FDA recall for the line of devices made in Oakdale. Smiths ...