Accyourate Group S.p.A has stepped up the commercialization of its e-shirt, a 100% textile smart T-shirt which enables continuous real-time monitoring of biomedical and vital body signals. Accyourate joins a host of companies releasing products in the wearable device market as different technologies for health care including heart rate monitoring, fitness, breathing, temperature levels and fall detection get more sophisticated and grow in popularity.

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.

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.