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.
With today’s 18-5 vote in the Senate Health, Education, Labor and Pensions (HELP) Committee to send Stephen Hahn’s nomination to the full U.S. Senate, the oncologist who currently serves as chief medical officer at the MD Anderson Cancer Center is just a step away from being confirmed as the next FDA commissioner. Read More
The impending resumption of the 2.3% tax on medical devices has industry actively seeking at least a new suspension. Now, the Tax Foundation, of Washington, has issued a report saying that the tax would cost more than 21,000 Americans their jobs and impose a $1.7 billion hit on the U.S. economy. Read More
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. Read More
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s traditional implant, the Osia implant bypasses damaged parts of the ear and sends sound vibrations directly to the cochlea. Read More
