The European Parliament (EP) has voted to affirm the proposal by the European Commission (EC) to extend the compliance timelines for the Medical Device Regulation (MDR) in an urgent vote that eliminated any chance of debate. The vote was a landslide, coming in at 564 votes in support and three nays.
Syntach AB has been awarded up to $17 million in equity financing by the European Innovation Council (EIC) for the development of its cardiac support system, a breakthrough device for heart failure patients. This approval follows the $2.67 million EIC grant announced in December 2021 constituting the equity portion of the $18.7 million of blended finance under the EIC accelerator program. “Thanks to this funding, we are on the way to offering our treatment on a global scale,” said Tor Peters, CEO of Syntach.
The U.K. government recently released its first ever medical technology strategy which aims to accelerate access to innovative medical technologies in the NHS. Although it was welcomed by the industry, and questions remain as to whether it goes far enough to address some of the challenges to the adoption of medical devices, eyes are on its implementation and whether it will achieve its aims.
GE Healthcare Technologies Inc. has just commissioned the first hospital site in the world to deploy Omni Legend technology, their next-generation 100% digital PET-CT scanner. The Cancer University Institute of Toulouse Oncopole (IUCT-Oncopole) in France is routinely using this new platform for cancer patients.
Bayer AG acquired Blackford Analysis Ltd., a British developer of artificial intelligence systems that help make diagnoses using medical images in the U.K. and U.S. The companies did not disclose any financial details. “This deal is part of our strategy to drive innovation in radiology, including the development and adoption of AI within the workflow, with the goal of ultimately improving patient care and advance our position in digital medical imaging,” Stefan Oelrich, a board member at Bayer AG and president of Bayer’s pharmaceutical division, told BioWorld.
Feeling “ashamed” of having to use metal flesh-piercing forceps to stabilize the cervix during the insertion of intrauterine contraceptive devices, David Finci a gynecologist and co-founder of Aspivix SA, turned to his brother Julien, a medical device engineer, for his thoughts on how to design a more suitable instrument.
Following on from wireless weighing scales, blood pressure monitors and smartwatches designed to track health indicators, Withings SA is now developing home urine analysis products.
Eurosets Srl reported the first patient treatments using Colibri, which the company asserts is the world’s lightest extracorporeal life support (ECLS) system. This first clinical procedure was performed using an ECLS device weighing less than 9 kg in the ICU department at the Arnaud de Villeneuve University Hospital in Montpellier, France.
Varian’s Halcyon and Ethos radiotherapy systems received two regulatory nods in short succession, with both U.S. FDA 510(k) clearance and CE marking. In addition, the company reported that the first patient in the world underwent treatment with a Halcyon system with Hypersight last week.
Eyenuk Inc. is significantly extending the scope of its artificial intelligence system for the automatic analysis of retinal images, adding the diagnosis of age-related macular degeneration (AMD) and glaucoma to the EU approved uses of Eyeart AI.
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