Neura Inc., which focuses on AI-powered behavioral intelligence that provides real-world insights for health organizations, governments and consumer brands, has revealed the adoption of its Viruscore COVID-19 predictive testing solution.
The COVID-19 pandemic has sparked some innovation in testing, but not all that innovation has made it to market. Michael Mina, an assistant professor of epidemiology at the Chan School of Public Health at Harvard University, said on an Aug. 7 conference call that the U.S. FDA’s “archaic view” of testing is impeding the use of paper strip tests he said would turn the tide in the effort to contain the pandemic.
People with diabetes are at risk of developing diabetic retinopathy (DR), an eye condition that can cause vision loss and blindness. However, early detection and treatment can slow its progress. To that end, the Food and Drug Administration has cleared the way for Eyenuk Inc. to market its Eyeart autonomous artificial intelligence (AI) system for DR screening in the U.S.
Keeping you up to date on recent developments in diagnostics, including: Facilitating analysis of scratch wound healing tests; Advanced imaging in children; Picturing molecular alterations.
Developers of tests for the SARS-CoV-2 virus have gained a tremendous amount of experience in a very small amount of time, and of all the media for sampling, saliva offers the easiest route for test administration. The U.S. FDA’s Tim Stenzel said on the Aug. 5 testing town hall, however, that the FDA and developers have discovered that this is an extremely difficult medium to work with.
The U.S. FDA gave an emergency use authorization (EUA) to the first semi-quantitative antibody test from Siemens Healthineers AG for the SARS-CoV-2 virus. This test, known as the SARS-CoV-2 IgG (COV2G) antibody test, could potentially be used repeatedly over time to assess relative levels to gauge potential immunity.
Eko Devices Inc. said Tuesday that it is collaborating with British pharma giant Astrazeneca plc to speed the development of digital health tools to improve early detection of cardiovascular diseases, including heart failure. The partnership could lead to more personalized care for heart failure patients, improving long-term outcomes.
Hologic Inc. beat expectations for the third quarter of fiscal year 2020, posting net earnings of $137.9 million, or 53 cents a share, up 46.9% from the same period a year ago. Worldwide revenue declined 3.5% to $822.9 million, due to the divestiture of Cynosure Holdings Inc., but grew 7.7% organically (8.1% in constant currency), as demand for COVID-19 tests offset a slide in other businesses.
Keeping you up to date on recent developments in diagnostics, including: Expanding sampling options for COVID-19 could increase testing; Envisia classifier improves IPF diagnosis; Structural study gives insight into plaque formation.
The U.S. FDA has nudged the emergency use authorization (EUA) program forward once again, this time with a template for applications for tests that can be performed entirely at home, in the office and at schools. FDA Commissioner Stephen Hahn said in an accompanying statement that tests of this sort “will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”