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Insulet has sent letters to users of its Omnipod DASH insulin management system with a warning about defective batteries in the personal diabetes manager (PDM) controller device. Read More
An FDA inspection of Hill Laboratories’ Frazer, Penn., facility found problems with complaint and audit procedures as well as the design of a light therapy unit. Read More
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