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Abbott has received FDA’s approval of its new Proclaim Plus spinal cord stimulation (SCS) system that allows physicians to program the device to treat evolving pain. Read More
Bioretec’s ActivaPin bioresorable implant has proven to be an acceptable alternative treatment for pediatric elbow fractures, researchers reported in the journal Medicine.
Event Medical did not properly investigate hundreds of complaints about failures in its ventilators, an FDA investigator observed in a Form 483 issued after a May 9-18 inspection of the company’s Irvine, Calif., facility. Read More
Event Medical did not properly investigate hundreds of complaints about failures in its ventilators, an FDA investigator observed in a Form 483 issued after a May 9-18 inspection of the company’s Irvine, Calif., facility. Read More
The Medical Device Innovation Consortium (MDIC) is moving ahead with plans to create a global, publicly available research library of somatic reference samples (SRS) — human cell lines containing important, cancer-causing mutations — for use in developing cancer diagnostic tests. Read More
An electronic document management system (DMS) should have internal and external safeguards to ensure that access to the computerized system and to the data is restricted to prevent unauthorized access. Read More
When facing a critical product complaint, the company is almost always going to want to get the product back to perform its own testing or examination to determine what corrective measures to take. Read More
Devon Orthopaedic Implants received a Form 483 from the FDA following a May inspection of its facility in King of Prussia, Pa., for failing to fully investigate complaints or report possible medical device issues. Read More
Medical device recalls reached their highest level in two years during the second quarter of 2022 with 268 events, a 34 percent increase from the 200 recalls in the first quarter, according to Sedgwick, a company that specializes in product recalls and remediation. Read More