Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, BMS, Cerecor, Chinook, Durect, Kintor, Mustang, Neurmedix, Paxmedica, Russian Direct Investment Fund, Sesen, SQZ, VBI Vaccines.
LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivecor, Althea UK and Ireland, Ambu, Ascensia, Avails Medical, Cadwell Industries, Cardiovascular Systems, Chansu Vascular Technologies, Circularity Healthcare, Earlysense, Fuse Medical, Hillrom, Innova Medical Group, Laborie Medical Technologies, Mayo Clinic, Orthovestments, Roche, Seegene, Senseonics, Setpoint Medical, Urotronic.
The latest global regulatory news, changes and updates affecting biopharma, including: Veterans’ genomic data put at risk; DNA sequencing claims struck down; More BREXIT guidance.
TORONTO – Startup CEOs may sometimes be forgiven a little exuberance on learning their technology has received the high sign from regulatory officials. So it was when the head of Monitio Intelligence Inc. Ben Su sifted through his email at his office in Coburg Ontario and saw the Health Canada logo at the top of the letter. “I was actually jumping up and down when I received that authorization letter. I was very excited,” Su said. Since then Su has been overseeing installation of an automated COVID-19 screening system.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA reissues policy for coagulation systems; FDA announces recall of Penumbra’s Jet 7; Stericycle to buy buses as part of settlement; Athena agrees to $18M fine; WHO refreshes essential diagnostics list; TGA pulls two pandemic-driven exemptions.
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