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

Dr. Michael Cantor Named Intuition Robotics 1st Chief Medical Officer

The company recently announced its plan to extend to healthcare.

Healionics Raises $4.7M Equity Round to Support Commercialization of STARgraft Vascular Graft

Healionics is preparing to commercialize its innovative STARgraft vascular graft, designed to provide a safer and more reliable means to access the bloodstream for dialysis in patients with kidney failure.

St. Elizabeth Healthcare Enhances Access To Cardiac Care With Multi-specialty Outpatient Building

"We opened the Heart & Vascular Institute six years ago with the goal of improving access to quality cardiovascular care for individuals in our region, and since then, we've made impressive strides in service offerings and patient outcomes," said D.P. Suresh, MD, Cardiologist and Executive Medical Director of the St. Elizabeth HVI.

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.” 

spot_img

DON'T MISS

Subscribe to Medical Device News Magazine here.

Related Articles