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 – 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 – Incepto Medical SAS, of Paris, raised $6.2 million from three French venture capital funds – Axa Venture Partners, Bpifrance through its Patient Autonome Fund, and Cap Decisif – to develop its artificial intelligence (AI) medical imaging platform. "This funding round is a first step toward accelerating [the] rollout of our [AI] medical imaging solutions on a grand scale throughout France," Incepto CEO Antoine Jomier told BioWorld MedTech.
PARIS – Six months after floating on the Euronext stock exchange in Paris, Predilife SA from Villejuif, France, is launching the Mammorisk predictive test for breast cancer risk in Europe and the U.S. "Mammorisk is the first multi-criteria test to use data mining, allowing it to combine medical imaging, genetic profile and family history," Pierre Verdet, assistant managing director of Predilife, told BioWorld MedTech.
