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Thursday, October 21, 2021

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HomeReflexion HealthReflexion Health Obtains 510(k) Extension for Trunk and Upper Extremities

Reflexion Health Obtains 510(k) Extension for Trunk and Upper Extremities

Reflexion Health has secured 510(k) clearance from the U.S. Food and Drug Administration to extend its flagship product for use with trunk and upper extremities. Previously, Reflexion Health’s Virtual Exercise Rehabilitation Assistant (VERA™) was only cleared for lower extremity.  

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. VERA seamlessly educates, demonstrates, measures, analyzes and records patients’ movements at home, all without the need for patients to apply or wear any sensors or monitoring devices. 

Reflexion Health now launches its trunk module, with the upper extremity module to be introduced later this year. 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. 

“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 Joseph Smith, M.D., Ph.D., chief executive officer of 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.” 

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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