Reflexion Health has secured 510(k) clearance from the US Food and Drug Administration to extend the use of its Virtual Exercise Rehabilitation Assistant (VERA) to the trunk and upper extremities.
Previously, VERA was cleared only for the lower extremities.
The trunk module is being introduced now, and the upper extremity module will be introduced later this year, according to the company in a news release.
The trunk module is designed for a variety of applications from helping patients recover before and after spine surgery to helping individuals who suffer from lower back pain.
VERA is a digital therapy platform designed by Reflexion Health that integrates a broad menu of prescription rehabilitation exercises, an animated avatar coach, a 3D imaging system for measuring movement, functional assessments, an intuitive dashboard for remote clinical review, automatic report generation, and telemedicine capability to deliver a comprehensive, home-based rehabilitation experience.
The platform is designed to educate, demonstrate, measure, analyze and record patients’ movements at home, all without the need for patients to apply or wear any sensors or monitoring devices, per the release.
“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,” says Joseph Smith, MD, PhD, chief executive officer of San Diego-based Reflexion Health.
“As we lead the transformation of physical rehabilitation by elevating the patient experience, we remain focused on delivering value-based, data-driven solutions.”
[Source: Reflexion Health]