TORONTO – Toronto-based Sqi Diagnostics Inc. has reported significant clinical progress developing three novel COVID-19 tests for submission for U.S. FDA emergency use authorization.
The U.S. FDA has granted emergency use authorization (EUA) to Genscript USA Inc. for its Cpass SARS-CoV-2 Neutralization Antibody Detection Kit, the first commercially available test to detect neutralizing antibodies in individuals previously infected with the novel coronavirus. The serology test measures levels of neutralizing antibodies in samples from patients recovering from COVID-19 as well as people vaccinated against the SARS-CoV-2 virus.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akida, Applied UV, Apyx Medical, Cleveland Clinic, Concept Medical, Epic, Orbusneich, P+F, Protec Scientific.
Keeping you up to date on recent developments in cardiology, including: What is causing COVID-19 blood clots?; Using machine learning to predict survival rates with OHCA; Remote cardiac rehabilitation proves itself.
Preparing for a Biden presidency in which COVID-19 will be a top priority, the Joe Biden-Kamala Harris transition team named a board of scientists and public health experts Nov. 9 to advise the team on how to respond to the surging pandemic in the U.S.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Genscript.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioelectronics, Careprotocol, Decision Diagnostics, Djo, Genassist, Hancock Jaffe, Mesa Biotech, Orthoalign, Progenity, Scott Specialties, Verida.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA tweaks export final guidance per CARES Act; OIG: CMS should act to recover payments for device credits.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE reviews Dexcom’s G6; Ortho claims EUA for antigen test with 100% sensitivity.
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