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Failure to fully investigate complaints or to properly qualify suppliers landed devicemaker Austco Marketing and Service a Form 483 after an FDA inspection at its Irving, Texas, facility.
The overhauling of the FDA’s oversight of in vitro diagnostics will see significant movement in 2023, according to Andi Fristedt, the agency’s deputy commissioner for policy, legislation and international affairs.
Maryland-based Medcura announced that the FDA has granted the company’s LifeGel absorbable surgical hemostatic gel Breakthrough Device designation as a hemostatic agent to control bleeding during surgical procedures.
Three years after closing its Willowbrook, Ill., medical device sterilization facility, Sterigenics and its parent company Sotera Health have announced a $408 million settlement of the more than 870 cases pending against it for claims that the use of ethylene oxide led to higher cancer rates near the plant.
Applications to the FDA for new devices that cited predicate devices subject to ongoing recalls resulted a higher risk of recall of the new devices, two research teams reported in the Journal of the American Medical Association (JAMA).
BioIntelliSense and care.ai have teamed up to combine their existing technologies to provide continuous monitoring from medical-grade wearables to improve clinical workflows in healthcare facilities.
An FDA inspection of an iRhythm Technologies facility in Irvine, Calif., resulted in a Form 483 to the firm for not establishing corrective and preventative actions, not submitting a medical device report (MDR), and other issues regarding the company’s cardiac monitoring system.
Interventional devices for heart rhythm disorders and neurovascular care, device software and assays featured among the top buyout announcements of medical device companies in 2022 — led by the Johnson & Johnson (J&J) $16.6 billion Abiomed purchase.