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The FDA has handed Allied Healthcare Products a Form 483 citing improper handling and documentation of product nonconformances following an inspection of the company’s facility in St. Louis, Mo., in April and May. Read More
The partners aims to provide virtual care for patients with type 2 diabetes, hypertension and mental health, as well as for musculoskeletal pain. Read More
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
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