Chronic disease patients are facing serious risks both from keeping away from necessary care settings, as well as from potential COVID-19 infection. One in five chronic disease patients was already starting to avoid seeking care in physician’s offices and hospitals, according to a survey that started early last week of a panel of 1,300 chronic disease patients across several indications.
As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ariosa Diagnostics, Illumina, Transmedics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Neural Fiber Optic Systems, Medx Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Extracts, Arima Genomics, Asuragen, Aytu Bioscience, Becton, Dickinson and Co., Biogx, Blue Earth Diagnostics, Bracco Imaging, Caredx, Cefaly, Co-Diagnostics, Datos, Geacom, Haselmeier, Healthcall, Heiq Materials, IDbyDNA, Illumina, Impulse Dynamics, Invo Bioscience, Nobio, Pharmajet, Qiagen, Roche, Supergum, Tandem Diabetes Care, Twist, West China Hospital, XCR Diagnostics.
“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.”
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.”
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bgi, Endologix, Thermo Fisher Scientific.
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