U.S. Food and Drug Administration (FDA) Cleared a VR-based platform Designed to treat chronic low back pain. On Tuesday, it cleared AppliedVR’s EaseVRx platform to help relieve pain in adults 18 and older.
This will be the first product approved by the FDA since AppliedVR was established in 2015. The Los Angeles-based company first provided VR headsets to patients in the hospital to ease the noise and stress in the hospital. But then it will focus on building tools that people can use at home.
The eight-week treatment plan includes a total of 56 brief daily VR sessions. Unlike some other virtual reality solutions on the market, AppliedVR’s first product focuses less on physical therapy exercises, but more on relaxation techniques and cognitive behavioral therapy. For example, one of the courses will instruct patients to practice deep breathing in a 3D natural scene.
EaseVRx was approved through the FDA’s de novo route, which is suitable for low to medium risk devices that are different from any devices currently on the market. The FDA made a decision after reviewing the results of a randomized, double-blind study of 179 people. The study showed that two-thirds of People who use EaseVRx report a pain reduction of more than 30%, In contrast, 41% of participants used fake VR programs.turn out Published on JMIR earlier this year.
In other words, although the trial showed good compliance (more than 90% of people adhered to the plan), it did not do well in recruiting diverse participants (most of whom were white, female, and college-educated participants). not good.
One of the company’s next obstacles will be to reach an agreement with the payer to cover its equipment.Applied virtual reality Recently raised $36 millionSome of them plan to conduct additional tests to show the clinical efficacy and cost-effectiveness of the device.The company stated in a press release that it plans to complete health economics and results research with commercial payers, and is also working with commercial payers Geisinger Two independent studies were conducted with the Cleveland Clinic to test VR as a backup tool for opioids.
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