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.”
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bone Biologics, Dermtech, Lamed, Nordic Nanovector, Precision Neuroscience , Prenosis, Spectronrx, Sqi Diagnostics, RLS, T2 Biosystems, Translumina.
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.
The French national authority for health (HAS) has provisionally set up CEDiag, a committee for assessing diagnostic, prognostic or predictive health technologies. This new national committee will cover the field of clinical procedures, including radiology, clinical biology and anatomo-cytopathology examinations, diagnostic drugs such as contrast agents used in medical imaging and radiopharmaceutical drugs, as well as medical devices such as self-testing kits.
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
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