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The FDA said the benefits of using Coloplast’s Restorelle mesh device for transvaginal repair of pelvic organ prolapse do not outweigh the risks, based on findings from a postmarket surveillance study. Read More
The Center for Devices and Radiologic Health (CDRH) Monday released a priorities list of draft and final guidance documents it plans to publish in 2023, including two final documents focusing on the regulatory transition out of the COVID-19 public health emergency. Read More
Brooklyn, N.Y.-based FesariusTherapeutics’ DermiSphere dermal scaffold supported a skin graft from full-thickness skin loss more effectively and more quickly in a preclinical study than existing dermal templates, the company’s researchers reported in the peer-reviewed Journal of Tissue Engineering and Regenerative Medicine. Read More
The FDA issued Advanced Facialdontics a Form 483 for lacking a complete design history file and other deficiencies observed during an inspection of the company’s East Islip, N.Y., facility in July. Read More
The FDA has granted Emergency Use Authorization (EUA) to Winnipeg, Canada-based PADM Medical’s biodegradable, plant-based face mask for use in healthcare and medical settings. Read More
Federal juries in Texas and Arkansas have found in favor of Johnson & Johnson’s Ethicon subsidiary in two lawsuits over the company’s pelvic mesh product used to treat stress urinary incontinence in women, finding that the device had no design defect. Read More