BOGOTA – Mexican home appliances manufacturer Mabe Sa De Cv, from Mexico City, became a new member of the med-tech sector after taking the leap forward and joining the scores of companies around the world shifting their traditional manufacturing lines to develop med-tech products to fight COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 1drop, Agilent, Edwards, Everlywell, Fulgent Genetics, Zebra Medical Vision.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Hospitals Group, Beckman Coulter, Behold.ai, Dascena, Illumina, Natera, Philips Healthcare US, Pulmonx, Qiagen, Renalytix AI, SyntheticMR, Thermo Fisher Scientific.
Keeping you up to date on recent developments in cardiology, including: Robotic PCI reduces radiation exposure; COVID-19 and cardiovascular problems; Heart attack prevention falls short for stroke, PAD patients; Integrated herpesvirus-6 is pre-eclampsia risk factor.
TORONTO – The Toraymyxin (PMX) hemoperfusion cartridge developed by Toronto’s Spectral Medical Inc. and used successfully to treat patients during the avian and swine flu pandemics is being eyed to help COVID-19 patients in Canada. Specifically, an emergency interim order from Health Canada expands its use to include treatment of COVID-19 patients with high levels of endotoxin in their blood and in acute respiratory failure.
Abbott Laboratories’ ID Now test for the SARS-CoV-2 virus made waves when it was introduced thanks to the rapid turnaround time the molecular test promised. But questions about the test’s performance have surfaced several times in recent weeks. The latest criticism comes from a study conducted at the New York University Langone Medical Center, which claims the diagnostic compared poorly against a competitor. However, the U.S. FDA said that it has questions about the swabs and transport media used in connection with the test. As a result, it will stand pat regarding the ID Now’s place in the emergency use authorization (EUA) program.
PARIS – Intrasense SA, of Montpellier, France, has gained CE marking for its CT scanner reading protocol designed for COVID-19. “This major step forward, coming at the same time as U.S. FDA clearance, will allow a true mass rollout of our Myrian XP-Lung system designed for COVID-19,” Nicolas Reymond, CEO of Intrasense, told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Balt, Caredx, Hologic.
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