Reflexion Health announced it received FDA 510(k) clearance for the Virtual Exercise Rehabilitation Assistant to be used for trunk and upper extremities. The digital therapy platform had already been cleared by the FDA for lower extremities.
“We are dedicated to helping patients recover more comfortably and confidently through [Virtual Exercise Rehabilitation Assistant] VERA, and our 501(k) extension will enable us to help more patients,” Joseph Smith, MD, PhD, CEO of Reflexion Health, said in a company press release. “As we lead the transformation of physical rehabilitation by elevating the patient experience, we remain focused on delivering value-based, data-driven solutions.”
According to the release, VERA integrates prescription rehabilitation exercises, an animated avatar coach, a 3-D imaging system for measuring movement, functional assessments, an intuitive dashboard for remote clinical review, automatic report generation and telemedicine capability.
The trunk module has been launched, and the upper extremity module will launch later this year. The trunk module was developed to help patients recover before and after spine surgery and to help patients with low back pain.