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The FDA checks supplier purchasing controls during inspections of distributors of finished devices but doesn’t inspect suppliers of device components, so some of the oversight is passed along to devicemakers. Read More
An international trial evaluating Elixir Medical’s DynamX Bioadaptor drug-eluting coronary artery implant has completed enrollment of 444 patients across 35 centers in Japan, Europe and New Zealand, the company said. Read More
Clearwater, Fla.-based Apyx Medical’s Renuvion dermal handpiece with the company’s helium plasma technology for dermal resurfacing succeeded in treating wrinkles in a clinical trial, researchers reported in the journal Lasers in Surgery and Medicine. Read More
UK-based Parasym’s neuromodulation device significantly improved cardiac mechanics and inflammation in heart failure patients in a clinical trial at the University of Oklahoma. Read More
Patients with nonsurgical refractory back pain (NSRBP) treated with Nevro’s Senza high-frequency 10-kHz spinal cord stimulation (SCS) device saw a significant improvement in a clinical trial. Read More
Devices and replacement parts that are “printed” using new three-dimensional printing technologies must meet the same quality benchmarks as traditionally manufactured devices, trade groups emphasized in written comments to the FDA. Read More
The FDA requires devicemakers to keep records of every step they take and every specification they set on the way to a finished, distributable device. And each device — or family of devices — they make must have its own set of three records or files that give a full picture of the device’s lifecycle, from design to production to distribution. Read More
An international investigational trial of India-based Sahajanand Medical Technologies’ self-expanding transcatheter aortic heart valve (THF) system, Hydra, showed the implanted system performed well after one year. Read More