The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Genmark Diagnostics, Oxford Nanopore.
COVID-19 stalled clinical trials, halted elective surgeries, and body slammed many med-tech companies’ revenues. Despite that, an industry report released by Ernst & Young (EY) finds that the pandemic also drove some positive changes in the med-tech industry including long-neglected attention to enterprise-wide business continuity.
LONDON – Industry is calling on the government to set out a plan for the safe and sustainable restart of non-COVID-19 clinical studies that were put on hold when the pandemic struck.
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 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.
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 Tuesday at the Cleveland Clinic’s 2020 Medical Innovation Summit. Moderator Lydia Ramsey Pflanzer, health care editor, Business Insider, highlighted a bright spot, noting that by the end of the third quarter, digital health startups were doing well, raising $9.4 billion, according to Rock Health.
RSS
