The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.” Read More
Proponents of telehealth have been pressing Congress to statutorily broaden coverage of telehealth since before the COVID-19 pandemic, and the Telehealth Expansion Act of 2023 carries the weight of at least some of these expectations. The House Ways and Means Committee’s health subcommittee recently voted 30-12 to pass along the legislation to the full committee, but the bill operates principally to allow high-deductible health plans to cover telehealth benefits before the enrollee has met the deductible, leaving a substantial amount of telehealth terrain unaddressed.
They call it the world's “first fully integrated wearable” ultrasound system for evaluating cardiovascular function while you walk, run, even ride a bicycle. Built on the nanoengineering research at the University of California San Diego (UCSD) the wearable ultrasonic system-on-patch (USoP) employs machine learning to interpret deep tissue vital signs data and track subjects in motion. Read More
Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure patient safety, said Tracey Duffy, deputy secretary for the TGA’s Medical Devices and Product Quality Division, during the recent Ausmedtech conference in Adelaide. Read More
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Avanos, Echosens, Happitech, Hardy, Luscii, Medical Technology Assoc., Obvius Robotics, Omron, Pixium Vision, Premier Medical, Serac Imaging Systems, Sunmed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Corneat Vision, Femasys, FX Solutions. Read More
