Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Siemens Healthineers, Transmedics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Active Implants, Antylia Scientific, Avantor, Cardiogenics, Covidgenic, Dnanudge, Fresenius Helios, Geistlich Pharma, Inanobio, Innovative Medical Engineering Technologies, Masterflex Bioprocessing, Natera, NRG Oncology, Vivolta.
Multiple sizes of Neptune Medical LLC’s overtube for gastrointestinal (GI) procedures that allows thin-walled tubes to toggle between flexible and rigid states received FDA clearance. With the clearance, the Burlingame, Calif.-based company now has nine sizes of cleared single-use overtubes with more in the wings. The Pathfinder endoscope overtube device uses Neptune’s Dynamic Rigidization technology to keep tubes from looping during procedures, a problem that leads to procedure failure, patient pain and complications in colonoscopy and other GI procedures.
The U.S. National Institutes of Health had its hands full with the Rapid Acceleration of Diagnostics (RADx) program as the COVID-19 pandemic unwound, but the agency’s other work on diagnostics is bearing fruit. NIH said Aug. 31 that its collaboration with an academic research institute has led to development of a test that predicts which patients suffering from neurofibromatosis will develop cancers with metastatic potential.
Locate Bio Ltd. has closed a £10 million (US$13.8 million) funding round co-led by investors Mercia Asset Management and BGF to advance its orthobiologics product pipeline. The Nottingham, U.K.-based startup, which spun out from the University of Nottingham’s School of Pharmacy, is hoping to disrupt the orthobiologics market with its drug releasing, bone grafting products.
PERTH, Australia – On the heels of a A$90 million (US$67.12 million) initial public offering on the Australian Securities Exchange, device company Trajan Group Holdings Ltd. has doubled its share price and is well poised for its next stage of global growth. Trajan makes precision consumable products, devices and solutions that used in analyzing biological samples.
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