Echosens SA obtained clearance from the U.S. FDA to expand the indications for screening with its Fibroscan system. The approval removes contraindications for pregnancy and active implant and includes patients with confirmed or suspected liver disease. It designates Fibroscan as a noninvasive aid for clinical management, diagnosis and monitoring of adult and pediatric patients with liver diseases. The age has been removed as the first selection probe and exam-type step.
France is tightening access to the reimbursed health care market for digital medical devices. The national Digital Healthcare Agency (ANS) reported that a standard interoperability and safety system for digital medical devices is coming into force.
The Gustave Roussy cancer center, specializing in cancer treatment, and its technology transfer subsidiary Gustave Roussy Transfert, reported the creation of startup Orakl SA, which develops a technology for modeling cancer tumors called the patient tumor avatar. Orakl leverages a unique collection of patient tumor avatars, combining biological and clinical data to fuel the therapeutic arsenal to fight cancer.
Affluent Medical SA reported initial success from the first minimally invasive transcatheter implantation of its biomimetic Epygon heart valve. This was placed in a 62-year-old female suffering from a severe form of mitral regurgitation, considered untreatable via traditional heart surgery due to multiple risk factors. This first-in-human trial was performed at the Molinette Hospital, part of the City of Turin University Hospitals of Health and Science.
Bellaseno GmbH and Evonik Industries AG joined forces to commercialize 3D-printed scaffolds used in bone regeneration. The scaffolds are made with Evonik’s Resomer polymers to address large and complex bone defects as an alternative to frequently less stable conventional methods.
Sanofi SA is launching its first connected data collector for recording insulin injection in real time. The launch was reported at the Francophone Diabetes Society (SFD) congress in Montpellier, France this week. Distribution will begin via the network of 21,000 pharmacies throughout France. The new Solosmart data sensor can be adapted to all Sanofi pre-filled insulin pens.
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.
Early-stage venture capital firm Karista SAS reported the third edition of its European digital health funds mapping report. This mapping included all funds with global headquarters in France, Germany, Spain, Italy, the U.K., Netherlands, Austria, Luxembourg, Belgium and the Nordics.
At the European Congress of Radiology 2023 in Vienna, a session was devoted to photon-counting CT (PCCT). A team of five clinical researchers from Germany, Ireland, Norway, the Czech Republic and Slovakia spent an hour presenting an update on the latest clinical progress for this new medical imaging technology.
Just three months after raising $12.9 million, Remedee Labs SAS reported it has signed a partnership with pharmaceutical group Upsa SAS to ramp commercialization of its smart bracelet for chronic pain. “We are going to rapidly deploy our non-invasive chronic pain relief technology throughout France and Europe,” David Crouzier, co-founder and CEO of Remedee Labs, told BioWorld.
