Cue Health Inc. became the first company to offer COVID-19 molecular testing for home use without a prescription following U.S. FDA emergency use authorization on March 5, 2021. The San Diego-based company’s isothermal nucleic acid amplification test (NAAT) detects RNA from SARS-CoV-2 virus present in the nostrils. “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription.”
The Biden administration imposed a regulatory freeze in January, which among other things affected the final rule for the Medicare Coverage of Innovative Technologies (MCIT) program. Despite the freeze, Cybil Roehrenbeck, a partner in the D.C. office of Hogan Lovells US LLP, told BioWorld that this program enjoys broad support in Washington, and thus should survive the new administration’s review of the program under Xavier Becerra, should he be appointed the Secretary of Health and Human Services.
The voluminous American Rescue Plan – the second largest stimulus package in U.S. history – has something for everyone. Almost. The $1.9 trillion package that passed the Senate over the weekend and is expected to be passed by the House March 9 failed to extend the current moratorium, set to expire April 1, on the 2% Medicare sequestration.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA blasts thermographic sensor system marketers; WHO to tackle breast cancer globally; PhRMA urges Biden to stand by IP rights; FDA ASCA workshop announced.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Biotechnologies, Cochlear, Ortho Clinical Diagnostics, Promaxo, Siemens Healthineers.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Endosurgery, Avacta, Gallup, Dentsply Sirona, Hancock Jaffe, Hologic, Ion Beam Applications, Mainstay Medical, Motus GI, Ndc, North American Dental Group, North Star Medical Radioisotopes, Oxford Immunotec Global.
Keeping you up to date on recent developments in cardiology, including: TAVR patients at low surgical risk still ahead vs. SAVR, but thrombosis a concern; Heart failure numbers nearly doubled between 1990 and 2017; COVID exerting large effect on heart health.
Shares of Paris-based Abivax SA (Paris:ABVX) fell 25.4% to €21 (US$25.07) on March 8 after the company said it would halt a phase IIb/III trial of its lead candidate, ABX-464, in high-risk COVID-19 patients for lack of efficacy. The decision was based on a data safety monitoring board analysis that Abivax said revealed a "lower than expected rate (10.1%) of progression to severe disease or death with no difference between ABX-464 and placebo groups," each of which also received standard-of-care therapy.
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