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.

For European biotech, the first quarter (Q1) of 2023 could hardly be described as the best of times – but the period did not represent the worst of times either. European firms engaged in drug discovery and development collectively raised $1.88 billion during this period. The tally is 4% less than the total raised in the comparable period last year, and it represents just 32% of the total raised during the COVID-19-fueled biotech boom during 2021. But it’s still the third highest Q1 raise during the last six years.

Centessa Pharmaceuticals plc’s launch of a phase I/IIa trial with LB-101, a PD-L1xCD47 candidate that emerged from the Lockbody platform, highlighted the firm’s efforts against solid tumors. But the diversified company has more in the works, including a registrational study with subcutaneous (subcu) Serpinpc, designed to treat hemophilia (hemo) B. Centessa has a program in narcolepsy, too.

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.

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.