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The FDA has provided an update on Philips Respironics’ recall of almost 18.7 million masks for use with bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines, deeming the recall Class 1 because of the risk of serious injury or death. Read More
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
Recalls can be messy, complicated matters, especially for manufacturers that don’t have a plan in place for analyzing a problem, determining a course of action and carrying out all recall-related tasks in compliance with FDA requirements. 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