President Donald Trump has issued an executive order enabling the Defense Production Act, which gives the U.S. Department of Health and Human Services broader leeway to conscript industrial production to deal with the COVID-19 outbreak. Read More
As COVID-19 testing remains elusive in the U.S., much of the nation’s focus has started to shift to how to treat the presumed millions of patients who are already or soon to be infected with the novel coronavirus. Read More
LONDON – As the epicenter of the COVID-19 epidemic shifted to Europe and the number of deaths in Italy exceeded the toll in China, the EU stepped up efforts to mount a coordinated response, with a big boost for collaborative R&D funding and a call for clinical research to be pooled in multicenter, multi-arm randomized controlled trials. Read More
Abbott Laboratories, of Abbott Park, Ill., is the latest company to receive emergency use authorization (EUA) from the U.S. FDA for a test to detect SARS-CoV-2, the novel coronavirus responsible for the COVID-19 pandemic. The company said it is shipping 150,000 Realtime SARS-CoV-2 tests immediately to existing customers in the U.S., with plans to produce 1 million tests a week by the end of the month. Read More
Albuquerque, N.M.-based Sandia Labs received a $6 million grant from the NIH to build a prototype for a wearable brain scanner. The noninvasive functional brain imaging system will use optically pumped magnetometers (OPMs) to conduct more accurate magnetoencephalography (MEG), while improving accuracy, increasing comfort, reducing imaging costs, and enabling use in more patients. Read More
PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alibaba Cloud, Avellino Labs USA, Aytu Bioscience, Bio-Rad Laboratories, Boqi International Medical, Chongqing Guanzan Technology, Co-Diagnostics, Cosara Diagnostics, Endra Life Sciences, Medtronic, Milken Institute, Novocure, Paragon Genomics, Vitalhub, Vizient, Zorion. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, CHF Solutions, Qiagen. Read More
Keeping you up to date on recent developments in diagnostics, including: ‘Virtual peer review’ aids cancer diagnosis; Adding spirometry to lung cancer screenings to detect undiagnosed COPD; See in 3D; AI and sleep medicine. Read More
