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.
HONG KONG – Matricelf Ltd., an Israeli medical 3D printing company based in Tel Aviv, has won a SEED AWARD and the ¥1 million (US$143,000) that goes with the prize. The Global Final of the SEED AWARD 2019 was held in Shenzhen, China. The organizer Seedland Group, China’s leading real estate company promoting technology innovation, said that Matricelf is working toward one day being able to manufacture the world’s first functional 3D printed human heart.
PARIS – Carmat SA, from Vélizy Villacoublay, France, has just raised $66 million from European specialist investors in the life sciences and medical technologies sector.
Boston startup Beta Bionics Inc. is headed into a pair of ambitious pivotal trials in 2020: one starting for an autonomous bionic pancreas device with insulin only and another to follow for a bihormonal version that also includes glucagon. These are expected to offer more precise, easy-to-use blood glucose maintenance for type 1 diabetes patients.
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