Sofinnova Partners launched a new investment strategy focused on digital medicine in a sign that investment in European startups, especially those at the intersection of biology, data and computation is returning. “It cannot be stressed enough that there is a need in the market for this,” said Edward Kliphuis, partner in the Sofinnova Digital Medicine Strategy.
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.
Startup Aiomic ApS received a capital injection in the form of a €1.3 million (US$1.4 million) convertible loan from Denmark’s Bioinnovation Institute (BII) that will allow the company to further develop and commercialize its artificial intelligence (AI)-driven Aiomic360 platform, which is designed to reduce the number of postoperative complications.
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.
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.
The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey.
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.
Device makers doing business in the EU finally have official word that the new implementation dates for the Medical Device Regulation (MDR) are in force, offering some vital breathing room for products already on the market. However, manufacturers that wish to obtain a new certificate for their legacy devices still have a lot of work to do as they must file at least a preliminary application for these devices with a notified body (NB) by May 26, 2024, not a mean feat given the crunch on notified bodies operating in the EU.
Medtronic plc has scored a CE mark for its Affera mapping and ablation system for atrial arrhythmias, mere months after acquiring the technology from cardiac solutions company Affera Inc. The dual-use system, which includes the Sphere-9 catheter and Affera Prism-1 mapping software, will be available in Europe beginning in the first half of 2023.
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