The U.S. FDA’s Antimicrobial Drugs Advisory Committee voted unanimously, 21-0, June 8 in support of Astrazeneca plc’s nirsevimab as a one-dose prophylactic for infants born during or entering their first respiratory syncytial virus (RSV) season.
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.
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.
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.
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.”
The U.S. CMS has wrapped up a coverage analysis for seat elevation systems that are accessories for power wheelchairs, but the agency went above and beyond the strict terms laid out in the proposed decision memo.
The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels.
It has been a tough spring for Fibrogen Inc., which reported another phase III miss on June 7, this time for rare disease drug pamrevlumab to treat non-ambulatory patients with Duchenne muscular dystrophy (DMD).
The question wasn’t if, but when and how, someone would challenge the Medicare negotiation provision laid out in the Inflation Reduction Act (IRA) that was signed into U.S. law last year.
The Fiscal Responsibility Act (FRA) has been signed into law by U.S. President Joseph Biden, heralding a five-year span in which increases in discretionary budget spending will be limited to 1% after a flat funding picture in the coming fiscal year.
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