Clinics, urgent care centers, busy hospitals, and patients can count on Hemoscreen, a miniaturized point-of-care hematology analyzer made by Pixcell Medical Technologies Ltd., to provide accurate complete blood count (CBC) results, according to a study published in the Journal of Applied Laboratory Medicine. The study found the small unit better differentiates between cells and adapts to inference than conventional laboratory blood analysis.

Genetesis Inc. received good news from the U.S. FDA in the form of a breakthrough device designation for Cardioflux for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. Mason, Ohio-based Genetesis provides biomagnetic imaging solutions with an eye toward ensuring safety. Its solution already has made an impression on clinicians.

In what U.S. FDA commissioner Stephen Hahn billed as “a major milestone” in testing for the COVID-19 pandemic, the FDA has granted an emergency use authorization (EUA) to Ellume Ltd., of East Brisbane, Australia, for the company’s COVID-19 home test. The rapid lateral-flow test for antigen detection can be obtained without prescription and will return results to the at-home user in 20 minutes, according to the FDA’s Dec. 15 statement.

It might not have helped Iron Man survive use of the Infinity gauntlet, but for individuals with chronically iron-poor blood, Sanguina Inc. ’s new mobile app could be a lifesaver. Atlanta-based Sanguina released Anemocheck Mobile, an app that measures hemoglobin levels, for the Google Play Store and will shortly add the app for iOS. Anemocheck analyzes a photo of the user's fingernail beds and provides the hemoglobin level on the screen. Hemoglobin levels provide the most common measure of anemia.

TORONTO – Waterloo, Ontario-based DarwinAI Corp. and Raleigh, N.C.-based Red Hat Inc.are developing a suite of deep neural networks for COVID-19 detection and risk stratification via chest radiography in cooperation with Boston Children’s Hospital. DarwinAI designed COVID-Net as “explainable” artificial intelligence (AI) that illuminates the inner workings of AI-driven medical technologies and promptly offered it on an open-source platform for the broader hospital community.

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.