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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
The company is launching a kit that includes the device and a tablet computer that is pre-configured for access to the cloud-based VirtualCare telemedicine platform. Read More
The FDA has also granted Enhertu an accelerated approval for treatment of this specific NSCLC patient population who have received a prior systemic therapy. Read More
A new DNA sequencing test that detects extra or missing fetal chromosomes has results comparable to standard clinical tests, is less expensive and can be done at the point of care in one day, according to a study led by researchers at New York’s Columbia University.
The FDA said it has received 44 more reports of deaths associated with the June 2021 recall of millions of Philips’s continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices.
When it comes to blood pressure monitoring at home, old-fashioned blood pressure cuffs work just as well as newer, app-based technology, researchers reported in the journal JAMA Internal Medicine. Read More
Sunnyvale, Calif.-based molecular diagnostics company Cepheid is embroiled in a controversy over access in developing countries to its tuberculosis diagnostics test, which was funded in part by the World Health Organization (WHO). Read More
The FDA has updated its guidance for manufacturers of in vitro diagnostic devices who want to use a previously cleared instrument assay, or replacement reagent, on another instrument, providing information on when and how to determine if a new 510(k) application is needed. Read More