Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alliancerx Walgreens Prime, Bruker, Canopy Biosciences, Clearside Medical, Collective Medical, Fio, Genetic Technologies, Intelelabs, Intersect ENT, Natera, NaviFUS, Nebraska Health Information Initiative, Noridian Healthcare Solutions, Relay Medical, Todos Medical, Veracyte, Xifin.
The rescission order directing the U.S. FDA to abandon regulation of lab-developed tests is scarcely three weeks in the past, but two senior managers at the FDA are pushing back in an editorial appearing in the New England Journal of Medicine. The FDA’s Jeff Shuren and Tim Stenzel wrote that there is “a need for a common legislative framework” to ensure clinical tests are accurate and reliable, which implicitly concedes that the statute does not authorize the agency to regulate lab-developed tests.
Keeping you up to date on recent developments in diagnostics, including: Deep learning aid for diagnosing TB in HIV patients; Self-collected swabs vs. health care worker collected for COVID-19 testing; SCAD vs. plaques in heart attacks; Diagnosing neuroblastoma in children.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Exsomed, Glaxosmithkline, Innoviva, Izi Medical, Verily.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avenu Medical, Axonics, Hyperfine, Medifiber, Reshape Lifesciences.
The Lifetime Initiative released a roadmap to revolutionize health care in Europe by implementing cell-based interceptive medicine in a perspective article published Sept. 7 in Nature.
A new type of SARS-CoV-2 antigen test that relies on single molecule array technology may be able to help clinicians identify which patients are most likely to experience severe disease.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neuromatrix, Snyders Heart Valve, St. Jude Medical, Thermo Fisher Scientific.
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