Antibiotics specialist Bioversys AG has sealed a potential CHF529 million (US$667.5 million) deal with Shionogi Co. Ltd., in which they will work together on novel ansamycins for treating multidrug-resistant lung infections caused by non-tuberculous mycobacteria.
The Medical Device Coordination Group (MDCG) posted a guidance document tackling the interaction between the Artificial Intelligence Act and the twin EU regulations for devices and diagnostics, but the lack of standards for AI development promises to impede efforts to bring these AI algorithms to the European market.
Medtronic plc received a CE mark for its Vitalflow extracorporeal membrane oxygenation (ECMO) system, which provides temporary support for the heart and lungs in critically ill patients in intensive care units (ICU). The company said the Vitalflow ECMO system represents a ‘new paradigm’ in ECMO therapy as it is designed to simplify ICU operations and brings performance, ease of use and adaptability to the forefront of patient care.
Antibiotics specialist Bioversys AG has sealed a potential CHF529 million (US$667.5 million) deal with Shionogi Co. Ltd., in which they will work together on novel ansamycins for treating multidrug-resistant lung infections caused by non-tuberculous mycobacteria.
Anaconda Biomed SL recently received CE mark for the Ana5 funnel catheter, designed to improve mechanical thrombectomy in the treatment of acute ischemic stroke. The company hopes that the device, which has a vessel-matching diameter funnel to maximize the capture of blood clots, could be the holy grail in mechanical thrombectomy.
The joining of psychedelic specialists Beckley Psytech Ltd. and Atai Life Sciences can now go ahead after the pair announced positive top-line results from the phase IIb study of BPL-003, an intranasal formulation of 5-MeO-DMT benzoate.
The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022.
The U.K. Medicines and Healthcare Products Regulatory Agency reported June 24 it joined a global regulatory network for AI that is part of the Health AI regulatory initiative – a program that will invite another nine regulatory agencies to take part in the initiative in the months ahead.
The increased use of GLP-1 receptor agonists has led on to an increase in reports of acute pancreatitis in people taking these weight loss drugs in the U.K. That has prompted the launch of a pharmacogenomics project to investigate if there are any genetic links underlying the occurrence of this adverse event.
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