The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Instructions needed for self-sampling from nares; House Dems blast FDA decision on lab test review; DOJ take-down identifies massive telehealth fraud; Health Canada explains COVID-19 disclosures; GAO says FDA lab safety office lacks teeth.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Development of Additive Manufacturing, American College of Cardiology, Butterfly Network, Castle Biosciences, Cb Scientific, Curvafix, Dexcom, Eli Lilly, Fondazione Michelangelo, Fortanix, Fresenius, Intel, Isoplexis, Livongo, Mango Wellness, Microsoft, Mölab, My Cardia Thailand, Mybio, Nanovibronix, Nec Oncoimmunity, Oncocyte, Palmetto GBA Moldx, Rhythm AI, Scanwell Health.
Keeping you up to date on recent developments in diagnostics, including: Improving sensitivity of COVID-19 tests; Deep learning algorithm helps triage suspected COVID-19 cases; Cancer image analysis tool incorporates HER2 biomarker assay.
The ongoing pandemic brought about several challenges for investors looking for the next big thing, but some areas still have experienced growth. Experts addressed this topic and other issues during a panel discussion Oct. 6 at the Cleveland Clinic’s 2020 Medical Innovation Summit.
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada explains COVID-19 disclosures; TGA on changing sponsor details; FDA awards research grants for rare diseases; Se habla español.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerecin, Eton, Neurocrine, Regeneron, Revelation, Rhythm AI, X4, Xenon, Xortx.
The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing.
Lumos Diagnostics Holdings Pty. Ltd. scooped up AU$25 million (US$17.9 million) in an oversubscribed pre-IPO ahead of its anticipated 2021 listing on the Australian Securities Exchange (ASX). The funds will be used to expand manufacturing operations in California and Florida and to grow the commercial footprint of Febridx, a rapid point-of-care (POC) test that can determine if a person has a viral or bacterial infection within 10 minutes.
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