Elypta AB has devised new multi-cancer early detection technology leveraging plasma and urine glycosaminoglycans which can detect more than a dozen types of cancer in adults showing no symptoms.
Europe has given device makers more time to meet requirements set out in the 2017 Medical Devices Regulation (MDR). The European Parliament approved in mid-February an extension of the transition periods for medical device and IVD manufacturers to comply with the new rules, which aim to enhance safety for patients and ensure the “smooth functioning of the internal market.”
Visionhealth GmbH will use the €3 million (US$3.2 million) it recently raised in a pre-series A financing to conduct a clinical trial on its digital health app designed to provide more accurate dosing of treatments for chronic obstructive pulmonary disease (COPD) and asthma.
More than two months after a voluntary recall by Zimmer Biomet Holdings Inc. (ZBio), the U.K. Medicines and Healthcare products Agency (MHRA) issued an alert confirming the U.K. National Joint Registry has identified that there are higher revision rates for certain of the company’s total knee replacement prostheses, as compared to all other knee replacements in the registry.
Avicenna.AI SAS secured a further $7.5 million in series A funding, bringing the total aggregated investment in the company so far to $10.4 million. The round was backed by the two existing Paris-based investors: Cemag Invest SAS and Innovacom Gestion SAS. “Thanks to this funding, we are now able to ramp deployment of our software platform around the world, as well as diversify our offering into new areas of medicine,” Cyril Di Grandi, CEO and co-founder of Avicenna.AI SAS, told BioWorld.
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.
Dianosic SAS recently raised €4.7 million (US$5.04 million) from investors, in its second round of financing, and will use the funds to finance its preclinical in vivo testing and launch the first phase clinical trial for its Active Resorbable Intranasal Scaffold (ARIS) solution to treat chronic allergic rhinitis.
