PARIS – Carmat SA has just completed a capital increase of $66.4 million to boost development of its total artificial heart. The Aeson system was awarded CE marking four months ago, as a total bridge to transplantation for patients suffering with end-stage biventricular heart failure who are not eligible for maximal medical therapy or a left ventricular assist device (LVAD), and who are likely to undergo a heart transplant within 180 days of the implantation.

According to the latest annual overview published by trade association France Biotech, French med-tech, biotech, and e-health companies have adapted rapidly to the COVID-19 pandemic. Many French health care companies have faced real difficulties in all areas of procurement, R&D, and sales. As of February, a quarter of these French companies were redirecting their research activity towards the coronavirus.

LONDON – New research shows it is possible to diagnose Parkinson’s disease by mass spectrometry analysis of sebum samples taken with a simple skin swab, and that the same technique has potential to be used for diagnosing COVID-19. In a paper published in Nature Communications on March 11, 2021, scientists and clinicians in the U.K. and the Netherlands describe using high resolution mass spectrometry to profile the chemical signature of lipids and other biomarkers in sebum from Parkinson’s patients and show how these exhibit subtle but fundamental changes as the disease progresses.

Mahana Therapeutics Inc. obtained a CE mark for Parallel, a prescription digital therapeutic device to treat irritable bowel syndrome (IBS) in conjunction with other IBS treatments. Developed by a team of U.K. psychologists, the three-month program delivers cognitive behavioral therapy (CBT) via a web-based application.

MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.

PARIS – Median Technologies SA has unveiled a new clinical development plan for its Ibiopsy platform to provide early diagnosis of lung cancer in at-risk populations using low dose CT scans. Median executives said they hope to demonstrate the potential of deep learning in identifying lung lesions and characterizing them as malignant or benign.

DUBLIN – Sofinnova Partners closed out its crossover fund at €445 million (US$535 million), a total, it said, that makes it Europe’s largest crossover investor in biotech. It’s almost three years since Paris-based Sofinnova Partners completed an initial close at €275 million. “We didn’t set a bar – we thought between €250 million and €400 million would be great,” Antoine Papiernik, chairman and managing partner at Sofinnova, told BioWorld.

In Belgium, the National Institute for Health and Disability Insurance, INAMI, will reimburse costs for mobile health care applications as part of a care pathway. The move follows the green light given recently by the health care insurance committee. Online platforms, mobile apps and connected devices all have grown in popularity in recent months against the backdrop of the COVID-19 pandemic.

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.”