The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA lists entities recognized under ASCA program.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Braid Health, Cardiawave, Cepheid, Fluidigm, Neuronetics, Zymo Research.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspen Surgical, Baxter, Babybe, Blue Earth Diagnostics, Bodycad, Canon Medical Systems, Cloudbreak, Cohealo, Curtis Mathes, DarwinAI, Emphysys, Exactech, Flirtey, Fluidx, Glassbeam, Gigcapital2, Harpak-Ulma, Insightec, Ixlayer, Lockheed Martin, Median Technologies, Natus Medical, Nucleis Radiopharmaceuticals, Pack Health, Paramit, Premier, Protek Medical Products, Storm ID, Todos Medical, Uphealth, Vault Health, Zebra Medical Vision.
Hot on the heels of news that two vaccines for COVID-19 are nearing market readiness, two companies have broken away from the pack of assay manufacturers to offer quantitative antibody tests that can verify whether the vaccines provide effective, lasting protection. Siemens Healthineers and Imanis Life Sciences both claim to be first to develop scalable, quantitative neutralizing antibody tests.
Concerns about biopharma executives profiting from stock sales aligned with releases of promising COVID-19 vaccine results could result in Congress requiring a cooling-off period for executives’ 10b5-1 plans that provide a safe harbor to insider trading. Testifying in a Nov. 17 hearing before the Senate Banking Committee, SEC Chair Jay Clayton suggested a mandatory period of four to six months between implementing or materially changing a 10b5-1 plan and the first allowed stock sale. He added that the cooling-off period should at least cover a full quarter.
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