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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
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
Therma Bright said it is “the first company in the COVID-19 diagnostic testing space to successfully complete a 15-minute rapid antigen saliva-based U.S. study.” 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
A late-stage trial of BioCardia’s CardiAMP cell therapy system for heart failure has passed a milestone, with the independent data safety monitoring board recommending that the study continue as designed. Read More
Patients using Boston, Mass.-based Myomo’s MyoPro powered arm and hand brace showed statistically significant improvements in motor function in a pilot study, according to new research published in the journal Frontiers in Neurology. Read More
St. Paul, Minn.-based Minnetronix Medical has teamed up with Canada’s INO Innovation Center to fast-track the process of bringing optical medical devices to market. Read More
Revibe Technologies’ said its medical device software product, FokusRx, for the treatment of children with attention deficit hyperactivity disorder (ADHD) improved participants’ symptoms in a feasibility study. Read More
Corvia Medical’s Corvia atrial shunt did not improve rates of cardiovascular death or non-fatal ischemic stroke after 12 months, or the rate of total heart failure events up to 24 months, in a late-stage trial reported in The Lancet. Read More
The FDA has designated BioCardia’s CardiAMP Cell Therapy System for heart failure a breakthrough device, making it the first combination cardiac cell therapy and device to receive this status. Read More
The agency is hoping for useful feedback from sponsors, researchers, investigators, trial participants, product manufacturers, healthcare professionals and the general public. Read More