Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Beckman Coulter, Biogen, Dotmatics, Fujirebio, Laboratory Corp., Sigsense, Smith & Nephew, Ultima Genomics, Venturemed.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airs Medical, Haemonetics, Stryker, Varian, Vialase
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With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a year or two to emerge.
C2N Diagnostics LLC’s two-factor blood test, Precivity AD2, showed 90% accuracy in diagnosing Alzheimer’s disease in a study presented at the Alzheimer’s Association International Conference in Philadelphia on July 28 and simultaneously published in the Journal of the American Medical Association. The following day, Quanterix Corp. presented results from its study that showed a multi-marker approach could maintain the 90% accuracy of its Lucentad test, while reducing the percentage of uncertain results from more than 30% to 10%, in line with the intermediate results demonstrated by Precivity.
Deepc GmbH recently raised a further $13 million in a series A extension round to close the round at $26 million for its artificial intelligence (AI)-based operating system, Deepcos, which is designed to provide radiologists with a wide variety of AI-based solutions.
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
Thermoablation of thyroid nodules meets the patient’s standard of minimal invasiveness and is supported by the literature as an effective treatment for these nodules, which may become cancerous.