This morning the FDA granted digital physical therapy company Reflexion Health a 510(k) clearance for its Virtual Exercise Rehabilitation Assistant (VERA) to be used for trunk and upper extremities.
VERA is a prescription digital physical therapy platform that uses an avatar coach to help patients with their rehabilitation. The platform has the ability to perform a 3D scan of the patient in order to measure their movement and analyzes their functional assessment. Patients and providers are also able to view a user’s progress and statistics on a dashboard.
This new clearance builds on the company’s 510(k) for lower extremities. In fact, the San Diego, California-based company got its first FDA 510(k) clearance for VERA in 2015.
WHY IT MATTERS
Traditional physical therapy can be expensive and a cost burden on many with a chronic health condition or an injury. This factor, coupled with the aging population in the US, has caused many to look at digital tools as a way of providing care to more patients in a home setting.
“We are dedicated to helping patients recover more comfortably and confidently through VERA and our 510(k) extension will enable us to help more patients,” Dr. Joseph Smith, chief executive officer of Reflexion Health, said in a statement. “As we lead the transformation of physical rehabilitation by elevating the patient experience, we remain focused on delivering value-based, data-driven solutions.”
It has also been expanding its offerings. In 2018 the company unveiled two new products called VERAHome for post-acute care physical therapy patients, and the VERAClinic for their clinicians, both of which are built on the Vera system.