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Reflexion Health Receives New 510(k) Extension for VERA

By November 18, 2019 No Comments
Reflexion Health Receives New 510(k) Extension for VERA

We’re proud to announce that we’ve received FDA 510(k) clearance for a new feature for our Virtual Exercise Rehabilitation Assistant (VERA®), enabling the product to provide form-triggered best practice reminders.

VERA is a physical therapy (PT) platform that combines avatar coaching, 3D motion-capture technology, remote clinical oversight, and telehealth visits with a licensed physical therapist so that patients can heal at home. The HIPAA-compliant system measures 25 joints and limbs in motion, 30 times per second.

The new FDA-cleared feature allows VERA to provide audio and visual messages to remind the patient of the best form to follow when the 3D motion-capture technology determines that they are performing the exercise incorrectly. VERA flags the feedback and motion capture for clinicians to review as they track their patients’ progress through the clinician portal.

“This recent clearance is another significant milestone in Reflexion Health’s mission to bring safer, more efficient, and convenient FDA-cleared medical device technologies to all patients,” commented Chief Compliance Officer Walter Cordiglia. “I’m pleased with how the agency continues to take the necessary steps to fulfill its commitment to modernize the pre-market process for a more streamlined and efficient regulatory oversight of digital health systems.”

VERA has gained early success for its ability to make recovery convenient for patients, insightful for clinicians, and cost-effective for payors. With this new feature, VERA gives patients additional confidence that they are performing PT exercises correctly and offers clinicians greater insights into their patients’ recovery.

You can learn more about VERA here. And for information on how to leverage Reflexion Health’s award-winning digital therapy products and services for the benefit of your organization, please contact us here.