Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asensus, Centinel Spine, Heartsciences, Mephy, Nvidia, Perimeter Medical, Polarean, Positron, Procyrion, Shape Memory Medical, Silony Medical, Tekton, Vida Diagnostics.
AI-Stroke SAS is developing an artificial intelligence (AI)-based application able to detect strokes in real time using a simple smartphone or a tablet. The med-tech firm has just won an award in the i-Lab 2023 innovation competition, supported by the French Ministry of Research and sovereign bank Bpifrance SA. “We use the latest AI and computer vision technology to replicate a neurologist’s expertise immediately anywhere, whereas non-specialists can make diagnostic errors up to 50% of the time,” Cédric Javault, CEO and co-founder of AI-Stroke SAS, told BioWorld.
While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alveofit, Boston Scientific, Implantica.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Body Vision, Click, Endologix, Indivior, Mediflex, Paige AI Inc., Profound Medical, Scipher Medicine, Strata Oncology.
Two U.S. federal government departments recently issued a series of guidelines for their handling of mergers and acquisitions in a draft that has provoked both support and opposition from observers. Barry Nigro of the George Washington University School of Law said he is concerned that the presumption that a transaction is necessarily anticompetitive will prompt litigation over that presumption and thus bog down the process of reviewing these transactions.
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