In this edition of Device Week, Medtech Insight managing editor Marion Webb reports on her discussions with diagnostic company executives at the recent American Association for Clinical Chemistry meeting in Anaheim. And senior reporter Catherine Longworth previews her feature on MDisrupt, a new company that touts itself as the world’s first medical diligence company for the healthcare industry.
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Successful implantations of a novel transcatheter mark a major step forward in treating congestion in heart failure, according to the California-based company that developed it. The procedure was part of a feasibility study evaluating the device’s safety.
Resitu Medical has received FDA 510(k) authorization for the RESL09 breast cancer biopsy device. This handheld minimally invasive device excises tissue samples with diameters up to 9 mm and will first reach market in the US. The company plans to expand the tool’s clinical claims and core size range.
Rapid Nexus hopes its regenerative wound-healing system can ease the burden of diabetic foot ulcers and amputations. Backed by early clinical data and $3.8m in seed funding, the start-up is targeting the VA as a launchpad into a $6.5bn US market, with FDA clearance expected later this year.
The Nancy Gardner Sewell MCED Act has advanced in the US House, potentially allowing Medicare coverage for multi-cancer early detection tests. Exact Sciences is targeting FDA approval for its MCED test Cancerguard, launched in the US earlier this month.
The Daxor Blood Volume Analysis (BVA) is aimed at improving care for heart failure patients. It will allow blood volume to be measured from the patient’s bedside for the first time and is also significantly faster than earlier testing methods.
Confido Health has raised $10m in Series A funding to expand its AI voice agent from patient scheduling into referrals, prescriptions and billing, bringing the total collected to $13m. CEO Chetan Reddy predicts in the next decade, AI use for admin tasks in healthcare will become mainstream.
Dexcom has endured recalls, layoffs and leadership change, but interim CEO Jake Leach said the company remains committed to innovating next-gen devices.
