Asep Medical Holdings Inc. reported “ground-breaking” use of artificial intelligence in its SepsetER test to rapidly identify infections at increased risk of severe sepsis. Developed under guidance by Professor Robert E.W. Hancock at the University of British Columbia, analysis of dysfunctional immune responses to identify particular sets of genes could signal when a patient is at risk of acquiring and potentially dying from severe sepsis.
GE Healthcare Technologies Inc. has launched Sonic DL, a deep learning technology designed to significantly accelerate magnetic resonance imaging (MRI) exams, after receiving regulatory clearance from the U.S. FDA.
Pulse Medical Technology Inc. obtained breakthrough device designation from the FDA for its fourth generation μFR system, which would accelerate the commercialization of the device. “The fourth generation μFR system is currently not available on the market, but Pulse Medical is preparing for the marketing approval of the product in the U.S.,” Jingfeng Han, director of science division at Pulse Medical, told BioWorld.
Merit Medical Systems Inc. is making progress on its acquisition badge, with a $100 million purchase of assets from Angiodynamics Inc. following shortly on the heels of its acquisition of a catheter system from Bluegrass Vascular Technologies Inc. for $32.5 million. The acquisitions strengthen Merit’s position in the specialty dialysis devices market and are expected to boost the company’s revenues $13 million to $15 million through Dec. 31, 2023, and by $30 million on an annualized basis going forward.
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Corneat Vision, Femasys, FX Solutions.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Avanos, Echosens, Happitech, Hardy, Luscii, Medical Technology Assoc., Obvius Robotics, Omron, Pixium Vision, Premier Medical, Serac Imaging Systems, Sunmed.
Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure patient safety, said Tracey Duffy, deputy secretary for the TGA’s Medical Devices and Product Quality Division, during the recent Ausmedtech conference in Adelaide.
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