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.

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.

Huntington’s disease is a fatal hereditary disease that results in the progressive breakdown of nerve cells in the brain. It erodes a person’s physical and mental abilities, usually beginning in their 30s and 40s, and to date has no cure. Now Austin-based Asuragen Inc. is joining forces with Wave Life Sciences USA Inc., of Cambridge, Mass., to develop companion diagnostics (CDx) for Wave’s investigative allele-selective therapeutic programs targeting the genetic cause of the disease.

Axonics Modulation Technologies Inc., of Irvine, Calif., reported revenue of $1.3 million for the third quarter of 2019, up from $0.2 million in the same period last year, but below Wall Street's forecast of $1.4 million. CEO Raymond Cohen attributed the miss to a seasonal slowdown in implants of Axonics' rechargeable sacral neuromodulation (r-SNM) system in international markets, as well as some U.S. physicians who were waiting for the device to win urinary approval. That milestone came Thursday when the U.S. FDA approved Axonics' r-SNM for the treatment of overactive bladder (OAB) and urinary retention. The indication for urinary retention represents the largest segment of the market for SNM devices and comes just two months after FDA approved the r-SNM to help patients with fecal incontinence. (See BioWorld MedTech, Sept. 10, 2019.)

A neuropsychologist consult is typically the first step for a neurologist in aiding in the diagnosis and monitoring of neurological conditions. But timely appointments for an assessment by these specialists can be difficult to obtain, even under the best of circumstances. To better enable neurologists to assess which patients are most in need of a consultation with a neuropsychologist, Royal Philips NV has launched an artificial intelligence (AI)-based cognitive assessment tool in the U.S. Known as Philips Intellispace Cognition, the digital, cloud-based assessment tool takes established neuropsychological tests and enables their administration by a medical assistant via a tablet in an office setting.