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The Sorin Group has sent a Dear Doctor letter to physicians after Hong Kong’s Department of Health received eight reports of faulty elective replacement indicators used to program the settings on three of the company’s pacemakers. Read More
Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last week by the Asian Harmonization Working Party. Read More
Physicians responding to a recent FDA survey reported good results with Intuitive Surgical’s da Vinci surgical system, but also highlighted a range of failures involving the robotic device. Read More
Infusion medication errors and alarm fatigue remain the leading health technology hazards for the coming year, a new report by the ECRI Institute says. Read More
Aptalis, a specification developer for the Flutter mucus clearance device, failed to report a contract manufacturer’s rework of devices to correct issues both this year and in 2012, a recent FDA warning letter says. Read More
CDRH plans to roll out 12 final guidance documents in fiscal 2014, including guidances on cybersecurity, the device appeals process and the global unique device identification database, or GUDID, the center revealed Thursday. Read More
The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet its own specification for mechanical testing. Read More
Medtronic was slapped with a 15-citation warning letter following a preapproval inspection for its MiniMed 530G continuous glucose monitoring system. Read More