New York and Rehovot, Israel-based in vitro diagnostics startup Todos Medical Ltd. is developing blood tests for the early detection of cancer and neurodegenerative diseases using Fourier-transform infrared (FTIR) spectroscopy. Now the company is looking to apply the technology in diagnosing infections, including the novel coronavirus, COVID-19. Read More
Synaptive Medical Inc., of Toronto, has secured Health Canada’s approval for Evry, the company’s superconducting head magnetic resonance imaging (MRI) system. The Evry system aims to provide imaging directly at the point of care in areas outside diagnostic imaging departments. Read More
PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration (TGA) is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends on Dec. 31, 2020. Read More
The U.S. FDA has posted an immediately-in-effect policy document regarding clinical laboratory development of diagnostics for the pathogen responsible for COVID-19 disease. The agency said the policy allows a lab to use any diagnostic before the FDA has completed an exhaustive review of the test. Read More
LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths. Read More
COVID-19 is bringing more pressure to bear on Congress to pass S. 2723, the Mitigating Emergency Drug Shortages (MEDS) Act, which has been sitting in the Senate Health, Education, Labor and Pensions (HELP) Committee since Sen. Susan Collins (R-Maine) introduced it in October 2019 – a few months before the novel coronavirus emerged. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cytosorbents, Cofactor Genomics, Todos Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alibaba, Bactiguard, Co-Diagnostics, Convatec, Diasorin, Implandata, Insulet, Lucid Diagnostics, Neogenomics, Pavmed, The Technology Partnership Vigilenz, Vivalnk. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fx Shoulder, Masimo, Tandem Diabetes Care. Read More
Keeping you up to date on recent developments in cardiology, including: MRI yields insights into blood flow of men, women; AHA: Take it slow and study with exercise; Intensive blood pressure control seen as extending life up to 3 years. Read More