PARIS – Less than a year after its formation, Acusurgical SAS, has secured a $7 million series A round to develop its robotic platform for assisting surgeons performing microsurgery procedures in retinal surgery. “Our goal isn’t to replace the surgeon but to increase his surgical capacities. Our mission is to create an augmented surgeon,” Christoph Spuhler, CEO and co-founder of Montpellier, France-based Acusurgical, told BioWorld.

The well-known overhaul of the European Union’s (EU) med-tech regulatory system was already a massive lift before the events of 2020, but the three-year transition period begins in 90 days with a large overhang of issues. Among these is that the ISO 14971 risk management standard is not recognized in the EU, and Adrian Keene, director of EU services for North American Science Associates Inc., said on a Feb. 25 webinar that “anything manufacturers can do to smooth the pathway” for device certification and recertification “is worth considering.”

Withings Health Solutions, the business-to-business division of the connected health company Withings SA, is launching two cellular-connected devices that allow patients to measure their weight and blood pressure at home and immediately transmit the results to a health care provider. The products – the Body Pro smart scale and the BPM Connect Pro at-home blood pressure monitor(BPM) – are being marketed directly to health professionals, as well as researchers and chronic disease management companies, for distribution to patients to use at home.

Diagnostics company Sphingotec GmbH is looking to break into the U.S. market with a pair of biomarker assays that could help determine the best treatment for critically ill patients at risk for septic shock. The two assays, which are run on the company’s point-of-care Nexus IB10 immunoassay platform, measure bioactive adrenomedullin (bio-ADM), a hormone that maintains endothelial function; and dipeptidyl peptidase 3 (DPP3), an enzyme that inactivates angiotensin II when released into the blood.

"Step up, speak up" could be the next mantra for COVID-19 screening at airports, universities and large employers if Vocalis Health Inc.'s screening tool takes off – and its recent CE mark approval makes that more likely. Vocalis reported that a large study found the tool, which uses AI-powered vocal biomarkers, had greater than 80% sensitivity and specificity, even in asymptomatic individuals.

Berlin – Fresenius SE & Co. KGaA reported that its global division, Fresenius Medical Care, and its Frenova Renal Research division have enrolled the first subjects in its new initiative to develop the largest genomic registry in the world to focus on kidney disease. At the same time, the German firm also announced that Ali Gharavi, chief of the division of nephrology at Columbia University Irving Medical Center, will lead the project and provide scientific guidance as principal investigator.

Organoids grown from cholangiocytes – the epithelial cells of the bile duct – are poised to be used in ex vivo cell therapy to increase the number of donated livers that are suitable for transplant, and also for direct bile duct repairs. The organoids have been shown to be effective in correcting defects in mouse models and in perfused donated livers. They are now being tested in large animal models.

If the SARS-CoV-2 virus has achieved anything useful in the world of in vitro diagnostics, it’s that the associated pandemic has shone a bright and unsparing light on the respective merits of diagnostic and surveillance testing. Harvard University’s Michael Mina, an assistant professor of epidemiology, was one of several academic researchers who took up the gauntlet yet again in opposition to what they characterized as a gross misunderstanding of the respective roles of these types of tests, a misunderstanding they said must be addressed if the pandemic is to be corralled.

Cardiacsense Ltd.’s medical watch received CE mark for the detection of atrial fibrillation and heart rate variability monitoring. The watch provides continuous, long-term monitoring of heart arrhythmias without cumbersome external devices or invasive implants. The European clearance does not require a prescription for use and will enable the Caesarea, Israel-based company to begin distribution under a number of agreements the company signed in 2020.

Blue Ocean Spine GmbH has won a major investment from SHS GmbH, also from Tuttlingen in Germany, to develop its next-generation functional spinal implant. The two companies are declining to disclose the size of the series A investment.