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The Jan. 25 issue of Device Daily Bulletin incorrectly characterized the reason for Medtronic’s recall of HeartWare Ventricular Assist Device batteries. The company has recalled the batteries to examine them for a potential weld defect.
The FDA has posted the latest analytics on its Global Unique Device Identification Database (GUDID), reporting a significant increase in the number of submissions as of Jan. 10.
The FDA issued updates on recalls of Datascope/Getinge’s Cardiosave Hybrid and Rescue intra-aortic balloon pumps (IABP) and certain Emergent reactive skin decontamination lotion (RSDL) kits, declaring them to be Class 1 recalls because of the “reasonable probability” that use of the devices could cause serious harm or death.
The commissioner called for improved “access to high-quality data from traditional clinical trials, electronic health records, and personal devices and wearable sensors.”
DePuy Synthes — a subsidiary of Johnson & Johnson — has agreed to pay $9.75 million to resolve allegations it violated the False Claims Act by paying kickbacks to a Massachusetts-based orthopedic surgeon to induce his use of DePuy products. Read More
FDA Commissioner Robert Califf laid out his priorities for “a major reformation of our national system for generating medical evidence” and wearable sensors were at the top of his list, in an article in the journal Clinical Trials. Read More
In a letter to the White House, AdvaMed defended the medical sterilization industry’s use of ethylene oxide (EtO) and asked for consideration of several points for the Environmental Protection Agency’s (EPA) proposed regulation of the sterilization process for medical devices.