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If the pump malfunctions, it could lead to organ dysfunction, a stroke or death, or it may require patients to undergo major surgery to replace the pump. Read More
The FDA handed Medical Chemical Corp. a Form 483 for not following its own written procedures after an inspection of the company’s Torrance, Calif., facility in March. Read More
The Association of Medical Device Reprocessors (AMDR) has issued an update on global regulatory standards for single-use medical device reprocessing and remanufacturing. Read More
Two separate lawsuits in the federal courts are claiming that Philips Respironics’ continuous positive airway pressure (CPAP) devices caused lung cancer, in one case leading to a death. Read More
Insulet has released pivotal trial extension data showing that its Omnipod 5 automated insulin delivery system continued to improve glycemic outcomes in young children over 12 months of use. Read More
New York-based DarioHealth reported positive results from several clinical trials of its digital therapeutics at the American Diabetes Association’s (ADA) 82nd Scientific Sessions in New Orleans, June 3-7. Read More