Michael Mina, assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, again criticized the U.S. FDA for taking a conventional regulatory approach to rapid antigen tests for the pandemic. However, not everyone at the FDA’s parent department deserves brickbats. Mina said Assistant Secretary for Health Brett Giroir deserves a lot of credit for assisting in the effort to stand up pilot studies for rapid antigen tests that could be used to restore the U.S. economy even in the absence of a fully rolled-out vaccination campaign.

Roche Holding AG has revealed a partnership with Moderna Inc. involving the use of the Elecsys Anti-SARS-CoV-2 S antibody test in the latter’s mRNA-1273 vaccine research trials. The news comes shortly after Roche received emergency use authorization from the U.S. FDA for the antibody test. 

The U.S. FDA has made it easier for people who want to get tested for COVID-19, granting emergency use authorization (EUA) for direct-to-consumer sales of Laboratory Corp. of America Holdings’ (Labcorp) Pixel COVID-19 test home collection kit. With this latest EUA, any individual 18 years and older can purchase the Pixel test system without a prescription.

Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.

LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD).

Harvard University’s Wyss Institute for Biologically Inspired Engineering licensed its Erapid electrochemical sensing platform to IQ Group Global to integrate with the Australian consortium’s transistor technology in a SARS-CoV-2 test. The combined solution could greatly simplify serological testing for the virus and help monitor immunity in individuals and populations over time.

Olympus Corp. has unveiled its plans to acquire Veran Medical Technologies Inc. for up to $340 million. The buy will go through Olympus Corp. of the Americas (OCA) and is part of the company’s corporate strategy revealed in November 2019. It marks the second M&A-related announcement in about a month.

For the 795,000 Americans who suffer a stroke each year, time is brain. The U.S. FDA granted 510(k) clearance to a solution the developer says could cut time-to-treatment in stroke by an hour, preserving 3.6 years of healthy life. Nico.lab’s artificial intelligence-based CT scan analyzer, Strokeviewer LVO, uses an algorithm that enables faster triaging of stroke patients and enables physicians to see the location of occlusions in minutes.