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Use of the defective devices could lead to patient injury or death, the agency warned, noting that 1,186 issues and a single injury have been reported so far. Read More
“The Fitbit ECG App may help prevent serious complications like stroke by allowing users to spot-check for signs of AFib from their wrist,” the company said. Read More
The FDA has granted Abbott Laboratories an Emergency Use Authorization for its COVID-19 antigen test, a diagnostic that provides fast, readable results on a card similar to some pregnancy tests. Read More
Specification developer Blue Belt Technologies failed to submit medical device reports (MDRs) for injuries associated with Smith & Nephew’s Navio tissue protector and bone pins, according to a Form 483 the firm received following an FDA inspection of its Pittsburgh, Pennsylvania facility. Read More
Inadequate design validation and risk analysis tripped up hearing aid maker Magnatone Hearing Aid Corp., during an FDA inspection of its Casselberry, Florida facility. Read More
Inadequate procedures for receiving, reviewing and evaluating complaints as well as other quality system shortfalls were observed during an FDA inspection of contract manufacturer LH Medical’s Fort Wayne, Indiana facility. Read More