Noze Inc. breathes a little easier with a new $5 million equity investment from the Bill & Melinda Gates Foundation to support the development of Diagnoze, a breath-based, hand-held diagnostic device. The foundation provided two earlier grants focused on diagnosing tuberculosis in low- and middle-income countries. “We're thrilled to see our partnership with the Bill & Melinda Gates Foundation continue to grow,” Noze CEO Karim Aly told BioWorld.

The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.

The U.S. Agency for Healthcare Research and Quality posted a request for information on the current state of multi-cancer screening tests for a review that poses several questions.

Sunbird Bio Inc.’s Neural EV-tau aggregate assay demonstrated 92% correlation with PET scans in identifying individuals with Alzheimer’s disease, a study presented at the Alzheimer’s Association International Conference in Philadelphia, on July 30 found.

The U.S. FDA proposed to overhaul guidances for maxillofacial systems that accumulated at least 18 years' of dust, in an effort to keep up to date with modern medical technology.

C2N Diagnostics LLC’s two-factor blood test, Precivity AD2, showed 90% accuracy in diagnosing Alzheimer’s disease in a study presented at the Alzheimer’s Association International Conference in Philadelphia on July 28 and simultaneously published in the Journal of the American Medical Association. The following day, Quanterix Corp. presented results from its study that showed a multi-marker approach could maintain the 90% accuracy of its Lucentad test, while reducing the percentage of uncertain results from more than 30% to 10%, in line with the intermediate results demonstrated by Precivity.

The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.

It’s a quad-pack for Edwards Lifescience Corp. as it reported its third and fourth deals this month – agreements to buy Jenavalve Technology Inc. and Endotronix Inc. for a combined up-front cost of about $1.2 billion plus up to $445 million in contingent milestone payments.

Regulation of artificial intelligence for medical devices is still a developing space, but market competition authorities in the European Union, the U.K. and the U.S. are already examining the potential for anticompetitive behavior in this rapidly growing technological arena.