HONG KONG – A new prototype hand-held device coupled with an artificial intelligence (AI)-powered app could make it possible for women to screen for breast cancer at home cheaply and efficiently. The device, the Blue Box, is the brainchild of Judit Giro? Benet, a 23-year-old junior specialist at the Center for Embedded Cyber-physical Systems at the University of California, Irvine, who is working with her Taiwanese partner Billy Chen to get their Blue Box to market.

The U.S. FDA granted a breakthrough device designation to Exero Medical Ltd.’s implantable smart sensor for early detection of anastomotic leaks after gastrointestinal (GI) surgery. The device continuously monitors the GI tract near the surgical site to alert providers about potentially deadly leaks.

As COVID-19 cases surge across the U.S., there is growing demand for greater access to testing to rein in the pandemic. On Wednesday, the U.S. FDA granted an emergency use authorization (EUA) to Abbott Laboratories for at-home use of the company’s Binaxnow COVID-19 Ag Card Home Test. Abbott has teamed up with Miami-based telehealth provider Emed to distribute and administer the tests, with an expected 30 million in the first quarter of 2021.

PARIS – Braintale SAS has completed a $1.2 million seed round towards its portfolio of digital quantification and prediction medical devices for neurology and intensive care. This funding round, including a loan from Bpifrance, attracted investment from business angels, as well as industry and health care professionals.

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.