The EU’s Artificial Intelligence (AI) Act is still in the thick of the legislative process, which seems likely to ladle even more regulatory liabilities onto AI software used for medical purposes. Bodo Wiegand, senior advisory at Viopsy, told attendees at a May 18 webinar that between the promise of yet more regulation along with existing coverage and reimbursement hurdles in the EU, developers of medical software are considering whether they should steer clear of developments that qualify as AI simply because of the extraordinary time and expense associated with generating revenues for these projects.
Elixir Medical Corp. reported that the Bioadaptor randomized controlled trial which compared its Dynamx coronary drug-eluting bioadaptor system to Dublin-based Medtronic plc’s Resolute Onyx drug-eluting stent (DES) in de novo native coronary arteries, met its primary endpoint of target lesion failure (TLF) non-inferiority at 12 months. The results were presented at a late-breaking clinical session during the EuroPCR 2023 conference in Paris.
Abbott Laboratories Inc. reported late-breaking data from the Bright study which showed that its Triclip transcatheter edge-to-edge repair (TEER) system reduced tricuspid regurgitation and improved the quality of life of patients with leaky tricuspid valves. The results from the largest real-world dataset were presented, for the first time, at the EuroPCR 2023 conference in Paris.
Olympus Europa SE & Co. KG is launching three Endoclot products, two hemostatic agents and a submucosal injection agent, in the Europe, Middle East and Africa (EMEA) region. This new portfolio was developed by Santa Clara, Calif.-based Endoclot Plus Inc., which expanded its distribution with Olympus from the U.S. to EMEA in December 2022. “The addition of their solutions to our portfolio allows Olympus to contribute to safe treatment in gastrointestinal procedures. We aim to improve patient outcomes and hereby elevate the standard of care,” said Stefanie Kaufung, EMEA business unit manager gastrointestinal endotherapy at Olympus.
It has become apparent that introducing two stents into the body to treat a patient with a bifurcation disease is not necessary and can be harmful, David Hildick-Smith, the lead investigator in a study, told delegates at the EuroPCR conference in Paris. Presenting late-breaking clinical data of three-year follow up results of different stenting strategies in patients with true left main stem bifurcation lesions, Hildick-Smith said that the results showed that only one in five patients needed a second stent.
Med-tech companies are facing a new reality of high interest rates, inflation, bank failures, and geopolitical turmoil that are impacting financing and M&A opportunities. To secure finance and attract partnership deals they must keep their product simple, focus on proof of concept and ensure that it has quality, delegates at the LSX World Congress in London heard during a panel presentation.
The European Innovation Council (EIC) equity fund will no longer be managed internally by the European Commission (EC) after September. Alterdomus Management Co. SA, a Luxembourg-based fund manager, will make the final decisions on which life science companies to invest in. The aim is to optimize how the EU’s main tool for driving innovation and economic growth in Europe operates.
Ciliatech SAS secured $3.87 million in series A funding to continue developing its second-generation implant to treat open-angle glaucoma. This round was led by its historical shareholders, including BNP Development SAS, Kreaxi SAS and individual investor Bernard Chauvin. “With this additional money, we can continue clinical trials to obtain the CE mark,” Olivier Benoit, co-founder and CEO of Ciliatech SAS told BioWorld.
Oso-AI SAS raised $10.7 million to develop its artificial intelligence (AI)-driven augmented ear for frail people and their caregivers. This series A financing round was led by its historical shareholders Innovacom SAS, Novinvest Partners SAS and Breizh-up, which is the co-investment fund of Brittany region financed by the European Regional Development Fund and managed by UI Investment SAS. Cemag Invest Partners SAS has joined these three historical investors. This operation follows a first round of financing of $4.4 million which closed in September 2020.
Xeltis AG reported the first-in-human results for its fully synthetic electrospun vascular access graft, showing 100% patency at six months in 20 patients with end stage renal disease who were not suitable for arteriovenous (AV) fistula creation.
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