Podcast: CEO Advises Digital Health Companies To Get Regulatory Help
This article was originally published in The Gray Sheet
Spencer Hutchins, whose company Reflexion Health's rehabilitation gaming software Vera was recently cleared by FDA says companies like his often have the engineering chops to build medical device software but not the regulatory know-how.
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Reflexion's Vera software that uses Microsoft's Kinect motion-tracking sensor system has been cleared by FDA to treat patients undergoing rehabilitation therapy from home.
In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA has waited.
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