AppliedVR develops Virtual Reality Theraputics prescription (VRx). Notably, the company’s EaseVRx product—an investigational device—is the first VR-based prescription therapeutic to receive “Breakthrough Device Designation” from the FDA. Josh Sackman’s talk covers the importance of clinical trials and FDA authorization for VR products, and essential topics about AppliedVR’s transition from a wellness product to a medical device: policies, plans, and procedures involved in conducting a clinical trial, partnering with respected healthcare institutions to navigate the code recommendations of medical societies and CMS, the importance of a rigorous evidence-based path to FDA approvals and clearances in the pursuit of innovative VR therapeutics.
