A new study evaluating Cardiologs’ deep learning tool for identifying patients at risk for atrial fibrillation (AFib) showed that it outperformed regular 12-lead electrocardiogram (ECG) testing. Read More

Miami, Fla.-based DermaSensor said two studies of its handheld skin cancer detection device — which could become the first FDA-cleared device of its kind for use by primary care physicians — have demonstrated the device’s efficacy. Read More

The FDA has just published the agency’s latest update to its Recognized Consensus Standard Database that device sponsors can cite in their device submissions. Read More

An early feasibility study is finding that hydrogel injected into lumbar spinal discs is safe while substantially relieving chronic low back pain caused by degenerative disc disease (DDD). Read More

Clare Medical of New Jersey reported in a recent study that its proprietary artificial intelligence (AI) tool that identifies elderly patients with a high probability of needing an emergency room (ER) visit or hospitalization within 30 days reduced these visits by 77 percent. Read More

Insulet has released pivotal trial extension data showing that its Omnipod 5 automated insulin delivery system continued to improve glycemic outcomes in young children over 12 months of use. Read More

New York-based DarioHealth reported positive results from several clinical trials of its digital therapeutics at the American Diabetes Association’s (ADA) 82nd Scientific Sessions in New Orleans, June 3-7. Read More

3DBio Therapeutics, a New York-based regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute in San Antonio, Texas, have partnered to reconstruct a human ear using the company’s AuriNovo 3D-bioprinted implant. Read More

Helsinki, Finland-based Bioretec’s bioresorbable Activa IM-Nail was effective in treating pediatric forearm fractures in an ongoing postmarket study by European researchers. Read More

Orthofix Medical’s M6-C artificial cervical disc showed significant benefit over spinal fusion in data from a five-year clinical trial conducted under and FDA Investigational Device Exemption (IDE). Read More

Efforts to improve diversity in clinical research can be greatly improved when sponsors take a hard look at their current practices and protocols, work directly with sites and consider adding sites well-suited for the task, a new report from the Advanced Medical Technology Association (AdvaMed) advises. Read More

Verily Life Sciences’ investigational smartwatch has shown potential for monitoring Parkinson’s disease in home settings in a multiyear European study. Read More