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  • FDA Approval for Auris’ Robotic Endoscopy Platform

    By Sean Kim on April 11, 2018 | Leave a response
    On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris' new system for robotic endoscopy. According to Auris Health, the Monarch Platform "integrates the latest advancements in robotics, micro-instrumentation, endoscope design, sensing, and data science into one platform." Josh DeFonzo, Auris' Chief Strategy Officer, noted some challenges with endoscopy and need ...

  • Theranos Charges Provide Perspective for Medical Device Companies, Biotechnology Companies, and Investors

    By Raj Pai on April 7, 2018 | Leave a response
    On March 14, 2018, the Securities and Exchange Commission (SEC) announced it filed charges against the founder and CEO of Theranos Inc., Elizabeth Holmes, and its former president, Ramesh Balwani. Theranos describes itself as a privately held technology company based in Palo Alto focused on developing lab-on-a-chip technology for blood testing.  By 2014, Theranos raised more than $400 million ...

  • FDA grants De Novo Market Clearance of Artificial Intelligence Software

    By Lindsay Laddaran on April 5, 2018 | Leave a response
    According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI's LVO Stroke Platform. According to PR Newswire, Viz.AI's LVO Stroke Platform is the "first artificial intelligence triage software" and its approval begins "a new era of intelligent stroke care begins as regulatory approval." The Viz.AI LVO Stroke Platfor ...
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