Beverly, Mass.-based Lexagene Holdings Inc. has developed a genetic analyzer with multiplex testing capability that would enable it to determine whether a patient has COVID-19, influenza or another respiratory infection with one sample. The Lx Analyzer uses a proprietary quantitative reverse transcription polymerase chain reaction (RT-qPCR) method to automatically test for up to 27 pathogens simultaneously, all in about one hour.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aduro, Align Technology, American Telemedicine Association, Aramark, Archerdx, Bristol-Myers Squibb, China Medical Holdings, Foxconn, Gelesis, Gingko Bioworks, Harvey Nash, Inivata, Medstar Health, Medtech Innovator, Medtronic, Monitorme, Natera, Nephros, One Medical, Philips, Quest Global, Usgi.
The U.S. FDA detailed which kinds of SARS-CoV-2 tests are getting top priority, with access to rolling, rapid reviews for emergency use authorization (EUA) during the unfolding pandemic. The agency is aiming to authorize point-of-care and at-home tests to better distribute the use of testing in various locations. It also is looking at automated and high-throughput tests that can offer analysis of larger batches of tests at one time.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BGI, BioIQ, Cigna, DNA Genotek, Illumina, Inspire Medical Systems, Lantheus, Metabolon, Nanostring, Orasure, Ortho, Phosphorous, Progenics, Respira, Sd Biosensor, Truvian, Yuyu Pharma.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Cae, Candela, Enexor Health, Foundation Medicine, Tandem Diabetes Care.
A wireless system to monitor mothers in labor and their fetuses has been introduced by Royal Philips NV in the U.S. Known as the Avalon CL Fetal and Maternal Pod and Patch, it is commercialized under recently updated guidance from the U.S. FDA. The Amsterdam-based company is continuing to pursue a standard 510(k) clearance for the system, which is marketed in European countries, Australia, New Zealand and Singapore.
Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bimini Health Tech, Binx Health, Cardinal Health, Copan, Cymedica Orthopedics, Debiotech, Exthera, Genmark Diagnostics, Healeon Medical, Healgen, Hill-Rom, Inovalon, Kardiac Devices, Keystone Heart, Kore, MD Anderson Cancer Center, Menarini, Neokidney, Ngmedical, Nicoya, Philips, Puritan, Second Sight, Svenska Labfab, Trialspark, Venus Medtech, The Wound Pros.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Exact Sciences, Halo Diagnostics, Lucence, Medtronic, Sequana Medical.
