The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device. The clarifications explain how to use the different levels of codes to guide the proper allocation of resources, citing the anticipated challenges with limited experience and competency of NBs.
All the primary endpoints were met in Hepion Pharmaceuticals Inc.’s phase IIa trial of CRV-431 for treating nonalcoholic steatohepatitis (NASH). The market, however, wasn’t celebrating as the Edison, N.J.-based company’s stock (NASDAQ:HEPA) sagged 15.27% on July 13 to close at $1.72 per share.
Diagnostics startup Geneoscopy Inc. has enrolled the first patients its pivotal CRC-PREVENT clinical trial. The interventional study will assess the safety and efficacy of the company’s noninvasive, at-home, multifactor RNA screening test for the prevention of colorectal cancer.
A five-minute artificial intelligence (AI)-based system from Cognetivity Neurosciences Ltd. that can detect common symptoms of Alzheimer’s disease years before they become visible using a tablet or smartphone is poised to change how this devastating disease is diagnosed.
Hyerfine Inc. and Liminal Sciences Inc. have joined a growing field of med-tech startups that are combining with blank check companies as an alternative path for venture-backed companies to an initial public offering (IPO). On Thursday, the companies announced a three-way combination with Healthcor Catalio Acquisition Corp., a special purpose acquisition company (SPAC), in a deal valued at approximately $580 million.
LONDON – Final results of the community pilot in Liverpool, U.K., that used the controversial Innova Medical Group Inc. lateral flow device to test all comers for COVID-19, show new cases fell by 21% compared to other areas of the U.K., because infections were detected early and people quarantined sooner.
GE Healthcare and Sophia Genetics SA partnered to develop new artificial intelligence (AI)-powered analytics and workflow solutions to improve patient matching with cancer therapies.
PERTH, Australia – Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Ltd. completed a A$63 million (US$47.44 million) initial public offering (IPO) on the Australian Securities Exchange (ASX) on July 5. “The funds raised will support U.S. commercialization of Febridx, to build our pipeline and to expand our operations so that we have the facilities and infrastructure in place to do automated assembly and manufacturing,” Lumos Diagnostics CEO Rob Sambursky told BioWorld.
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