The U.S. effort to deploy diagnostics for the novel coronavirus has been plagued by missteps by the CDC and the FDA from the outset, leading to delays and missed opportunities. The Trump administration declared a national emergency March 13, but concerns remain about how quickly the array of available tests can be conducted and whether there are enough testing supplies to handle the anticipated demand. Read More
The circuit breakers activated almost immediately when the markets opened this morning as the Dow plummeted, with investors moving into cash and away from equities. Clearly, they were not impressed with the Federal Reserve’s decision to slash its benchmark interest rate to nearly 0% to help combat the economic fallout from the coronavirus outbreak. Read More
“We look forward to the day where we can get back to normal,” U.S. President Donald Trump said Monday at a COVID-19 news conference in which reporters sat every-other-seat apart. In an unusually somber tone, the president said it now looks like it will be at least July or August before the outbreak “washes through.” Read More
The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.” Read More
Undetected cases were a major driver of the early spread of SARS-CoV-2 in Wuhan, China, despite being less infectious on a case-by-case basis, according to a modeling study published in the March 16, 2020, online issue of Science. Read More
Beta-O2 Technologies Ltd. plans to enroll its first patients in clinical trials for its second-generation bio-artificial pancreas, ßAir, in the coming months. The small, implantable titanium device has separate components that hold pancreatic cells and a rechargeable oxygen tank. Beta-O2 is based in Rosh-Haayin, Israel. Read More
Endologix Inc., of Irvine, Calif., has won approval from the U.S. FDA for its Alto abdominal stent graft system, the company’s next-generation Ovation system for polymer endovascular aneurysm repair (EVAR). The company plans to begin rolling out Alto initially to high-volume customers of its Ovation iX system, who are already skilled at using Ovation stent grafts. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adventhealth, Asuragen, Axonics, Ben-Gurion University, BGI, Closedloop.ai, Co-Diagnostics, Curetis, Earlysense, Health Tech Innovation Systems, Medtronic, Nuprobe, Paragonix, Precheck Health Services, Premier Global, Qiagen, Sotera Wireless. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bgi, Endologix, Thermo Fisher Scientific. Read More
Keeping you up to date on recent developments in cardiology, including: Research reveals how stem cells repair damage from heart attacks; Study: Magnetic component in e-cigarettes interferes with ICD function; AI helps in predicting cardiovascular events, mortality. Read More
