The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy. Specifically, the assay will be used during the trial to analyze genomic markers to direct patient enrollment and stratification.

The U.S. FDA has granted breakthrough device designation for Righteye LLC’s eye movement-tracking vision system as a test for Parkinson’s disease. Developed by researchers at PADRECC and Virginia Commonwealth University with funding from the Michael J. Fox Foundation, and licensed to Righteye in 2016, the test requires patients to sit in front of an all-in-one tablet-looking device and follow a series of moving targets. The goal is to identify ocular tremors, a persistent issue with Parkinson’s patients that prevents steady fixation on objects and images. The noninvasive test, which measures an individual’s ability to follow objects on a screen, could help doctors not only confirm the difficult-to-diagnose disease, but also detect it at earlier stages.

Boston-based conglomerate GE worked to make the case for its health care business to investors at a Dec. 2 event, but Wall Street seemed underwhelmed. The company’s share price remains hovering around lows not seen since the 2008-2009 financial crisis.

HONG KONG – Neurophet Inc., a South Korean AI-based brain disease diagnostics company, has secured ₩6 billion (US$5.1 million) in series A funding. The med-tech startup produces solutions based on Segengine, the company’s own technology that automatically segments brain magnetic resonance (MR) images into 107 regions within a minute.

A new web-based tool allowing rapid in silico prediction of the ability of candidate antibiotics to accumulate in Gram-negative bacteria should enable subsequent prioritization of new compounds for synthesis and further evaluation, U.S. researchers reported Nov. 18, 2019, in Nature Microbiology.

TORONTO – Burnaby, British Columbia-based Clarius Mobile Health Inc. has launched a second-generation series of wireless ultrasound scanners aimed at expanding its foothold in the North American and European imaging markets. More portable and powerful than its predecessors – the Clarius C3 and L7 launched in 2016 – the L15 hand-held ultrasound scanner series also may find markets in cardiac and sports medicine, as well as anesthesiology.

The U.S. FDA has engaged in an overhaul of its software policies in the wake of the mandates spelled out by the 21st Century Cures Act. However, those policies are still a work in progress, as a recent FDA webinar made clear. The FDA won’t have long to put those policies into place as the U.S. House of Representatives is considering a follow-on to the Cures Act, dubbed Cures 2.0, which will impose yet more changes on the agency’s approach to software regulation.