PARIS – Vygon SA, of Ecouen, France, has acquired Advanced Perfusion Diagnostics SA (APD), a startup based in Lyon, France, that has developed Ikorus, a device that detects changes in visceral microvascular blood flow in the most critically ill hospital patients. Vygon did not disclose the financial details behind the agreement.

PARIS – The Syndicat National de l'Industrie des Technologies Médicales (SNITEM), the French national association of medical technology manufacturers, has just released a study looking at the development of this industrial sector in that country. This snapshot, produced every two years by the firm D&Consultants SAS on behalf of Courbevoie, France-based SNITEM and the bank Bpifrance SA, is based on a dual quantitative and qualitative approach.

PARIS – Carmat SA, from Vélizy-Villacoublay, France, has obtained full FDA approval for its investigational device exemption application (IDE). The company is now able to initiate a U.S. early feasibility study (EFS) of its total artificial heart. “This full approval to initiate a U.S. study confirms the FDA’s confidence in our ability to conduct a feasibility study of the first bio-prosthetic artificial heart in the United States,” Stéphane Piat, CEO of Carmat, told BioWorld.

PARIS – Sensome SAS, of Palaiseau, France, has closed a second funding round, of $9 million, with its original French investors (Kurma Partners SA, Invest Partners SA, BNP Paribas Développement SA and the Paris-Saclay Seed Fund), now joined by the Japanese-based Asahi Intecc Co. Ltd.

PARIS – The European mammography division of GE Healthcare Inc., based in Buc, France, has just performed the first breast biopsy guided by angiomammography, using the Pristina Serena biopsy robot on a patient at the Gustave Roussy Institute in Villejuif, France.

PARIS – White Fund SA, of Lièges, Belgium, secured $22 million for early stage financing of Belgian med-tech companies. “Our shareholders are investing in a specialized fund [that], beyond financial returns, [creates] expectations in terms of supporting the strong med-tech ecosystem in Belgium and advantages in terms of job creation,” explained Benoît Fellin, investment manager at Noshaq SA, manager of the White Fund.

PARIS – EY SAS has published the results of the first edition of a barometer dedicated to the role of artificial intelligence (AI) in French public hospitals. The health care sector, which is undergoing wholesale change in France, is suffering tight economic constraints and faces ever-increasing expectations from patients. “The development of [AI] in France is a priority. It's a matter of gauging it,” Loïc Chabanier, an EY partner responsible for health care, told BioWorld.

PARIS – The Cour des comptes, supreme body for auditing the use of public funds in France, independent from government and parliament, has just released its report on the operation of the French National Agency for the Safety of Medicines and Health Products (ANSM). Following 10 months of administrative and financial investigation, these financial controllers have highlighted the weakness of controls applied to medical devices placed on the market in France.

PARIS – Mauna Kea Technologies SA, of Paris, is welcoming a major shareholder on board. The company, which developed Cellvizio optical biopsy technology for tissue imaging directly at the cellular level, reported an increase in share capital for the benefit of Johnson & Johnson Innovation, JJDC Inc. The venture capital arm of J&J has invested $8.3 million by subscribing to 5,357,142 new shares at a unit price of $1.56.

PARIS – Diabnext SAS, of Versailles, France, has launched Clipsulin 3XS, a sensor intended to monitor and manage diabetes that the company says is compatible with all insulin pens on the market. “This is the first sensor that automatically reports insulin doses injected by the pen, in both children and adults,” Laurent Nicolas, co-founder and CEO of Diabnext, told BioWorld MedTech.