Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Echosens, Tela Bio.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axena Health, Coro Medical, Electrocore, Endonovo, Safe Life, T2 Biosystems.
The U.S. FDA reported yet another recall of intra-aortic balloon pumps made by Datascope Corp., an unfortunate development for patients in need of these devices that are still on the FDA’s list of devices that are in short supply. While no injuries or deaths have been reported in connection with the coiled connector cables that prompted the recall, the need to replace these cables could further crimp units needed to sustain patients during cardiac surgery procedures.
Vitestro Holding BV reported raising $12.7 million in series A financing round to develop the world’s first autonomous blood drawing device. This round was led by Sonder Capital Inc., alongside existing investors and new angel investors with experience in the clinical laboratory and med-tech industry. “Thanks to this fundraising, we are going to accelerate the product development, prepare EU marketing authorization, and initiate production,” Toon Overbeeke, CEO and co-founder of Vitestro, explains to BioWorld.
Surgvision GmbH received U.S. FDA 510(k) clearance for the Explorer Air II which will be deployed with pafolacianine, during intraoperative fluorescence imaging. The Explorer Air II will support surgeons in their battle to fight cancer, especially in cases of incomplete resection, as paired with pafolacianine, an imaging agent, it will help them improve tumor visualization and outcomes.
Ancora Heart Inc. reported 12-month data showing its Accucinch system significantly improves outcomes in heart failure (HF) patients, including positive changes in cardiac structure and function. The results, presented at the Technology and Heart Failure Therapeutics conference (THT 2023) in Boston, were simultaneously published in the Journal of Cardiac Failure.
One way to strike fear into patients and cardiologists alike is to merely mention the abdominal aortic aneurysm (AAA), an event that claims more than 10,000 lives per year in the U.S. alone. That death count might fall substantially going forward thanks to the U.S. FDA’s award of a 510(k) for the AAA algorithm by Viz.ai Inc., a new algorithm which may help clinicians address imminent rupture quickly enough to save the lives of thousands of American patients each year.
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