Visby Medical Inc. emerged from stealth mode to secure emergency use authorization (EUA) from the U.S. FDA for its Personal PCR device for detection of COVID-19 infections. It is the first FDA-authorized portable device to use the polymerase chain reaction technology for COVID-19 testing. The San Jose, Calif.-based company was known as Click Diagnostics Inc. until March 2020.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Axonics, Simplify Medical, Visby Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Medical Technology Association, Biocept, Boston Scientific, Dariohealth, Decision Diagnostics, Exagen, Gunze, Hancock Jaffe, Highmark, Hmc Healthworks, Icad, Mimedx, Misonix, Novartis, Ortho Clinical Diagnostics, Polarityte, Radiation Business Solutions, Radmax, Royal Philips, Siemens Healthineers, Startx, Titan Medical.
Next-generation sequencing may help provide clinicians with a speedier answer as to the identity of the second pathogen, a service that may prove critical to suppressing the fatality rate in this and in future pandemics, according to Robert Schlaberg, chief medical officer of IDbyDNA Inc., of Salt Lake City.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Aeye Health, Bond Digital Health, Cmr Surgical, Foundation Medicine, Fujifilm, HSS, Naval Research Laboratory, National Center for Advancing Translational Sciences, Optomed, Renalytix AI, Siemens Healthineers, Takeda.
CAJICA, Colombia - The Cuban government announced the successful development of a COVID-19 vaccine, but little is known about it beyond announcements that it has already started phase I trials.
The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said.
PERTH, Australia – Australian public health laboratories are collaborating to sequence the virus genomes of all positive COVID-19 tests in Australia to track the virus using genomics across the country. The Communicable Disease Genomics Network (CDGN) and Illumina Inc. will track COVID-19 by using next-generation genomic sequencing technology.
