TORONTO – Ka Imaging Inc. has received U.S. FDA 510(k) clearance for a portable, dual-energy X-ray detector that distinguishes itself from others in this class by delivering regular digital radiography, bone and tissue images in a single X-ray exposure. Designed for early detection of pneumonia, including COVID-19, the Reveal detection system also differentiates bone and soft-tissue.
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.
The digital medicine company Physiq Inc. has received a contract from the NIH to develop an artificial intelligence (AI)-based index that can provide an early warning that a patient with COVID-19 is in decline and needs medical treatment. The index, called the COVID-19 Decompensation Index (CDI) Digital Biomarker, will run on Physiq’s existing Accelerateiq computing platform, analyzing physiological data from FDA-cleared wearable devices to create a personalized baseline for patients who have tested positive for COVID-19.
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.
DUBLIN – Genentech has succeeded where Sanofi SA and its partner, Regeneron Pharmaceuticals Inc., have failed, in obtaining some sort of a positive signal from a clinical trial of an interleukin-6 (IL-6) inhibitor in COVID-19.
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.
While COVID-19 is responsible for about 14% of the regulatory data collected by BioWorld in 2020 and even though numerous clinical trials have suffered delays, the pandemic does not appear to have slowed the pace of the FDA’s approval process.