Reflexion Health has secured FDA 510(k) clearance to extend its virtual exercise rehabilitation assistant (VERA) for use with trunk and upper extremities. Previously, VERA was only cleared for lower extremities use.
Reflexion designed VERA as a digital therapy platform that integrates several components for a comprehensive, home-based rehabilitation experience without the need for patients to apply or wear any sensors or monitoring devices. It incorporates exercises, an animated avatar coach, a 3D imaging system for measuring movement, functional assessments, a dashboard for remote clinical review, automatic report generation, and telemedicine capability.
The San Diego-based company said it is now launching its trunk module, designed for a variety of applications from helping patients recover before and after spine surgery to helping individuals who suffer from lower back pain. An upper-extremity module is expected later this year.
“We are dedicated to helping patients recover more comfortably and confidently through VERA and our 501(k) extension will enable us to help more patients,” said Reflexion Health CEO Dr. Joseph Smith in a news release. “As we lead the transformation of physical rehabilitation by elevating the patient experience, we remain focused on delivering value-based, data-driven solutions.”
The company recently announced that separate studies found VERA to be was as safe and effective as traditional physical therapy while saving $2,745 per patient in a bundled-payment setting.