Aims to establish new, universal quality standards in motion health.
Scientific Analytics Inc. (“SAI”) today announced it has received FDA 510K medical device designation issued for its groundbreaking computer-vision-powered motion analysis technology, DARI Health, and formed a strategic collaboration with Hospital for Special Surgery (“HSS”), ranked #1 in Orthopedics for the past nine consecutive years by U.S. News & World Report.
SAI’s markerless DARI Motion computer vision and biomechanical analysis technology has been refined by more than 425 billion data points of human motion gathered across applications in wellness, military, athletics and healthcare. Collaboration with HSS, the world’s largest academic medical center specializing in musculoskeletal health, will integrate leading knowledge and technology to set new standards for full-body, dynamic motion analysis at population scale.
“We are excited to work with HSS to advance new standards in motion health and disrupt areas of healthcare where we continue to build upon our innovation leadership – as indicated by the recent FDA clearance of DARI Health,” commented Todd Gleason, President and CEO at Scientific Analytics.
“This collaboration is an important new part of the musculoskeletal care ecosystem being created by HSS, to make better quality injury prevention and treatment more widely available,” said Louis A. Shapiro, president and CEO of HSS. “SAI’s state-of-the-art technology complements additions and advancements to our clinical talent, physical locations, digital offerings and education delivery.”
“This emerging HSS ecosystem including the DARI platform will help set new standards in the quality and availability of musculoskeletal wellness, assessment devices, and solutions,” said Shapiro.
Joel Hungate, Scientific Analytics’ Vice President of Orthopedic Programs sees DARI Health and HSS revolutionizing the way the world addresses the emerging challenges of population-level musculoskeletal health: “There has always been a massive unmet technological need in musculoskeletal healthcare for an accurate, scalable, repeatable, and objective way to quantify human movement and guide clinical decision-making at the point of care, and this was traditionally not feasible within the constraints of any given clinical workflow, until now.”
SAI’s DARI Motion Health and HSS aim to provide the first medical device that will arm clinicians with an FDA-cleared, accurate, and reliable solution that easily and seamlessly captures clinically-relevant human movement data at the point of care. In doing so, the organizations aim to create a new standard in data-driven, value-based musculoskeletal health while objectively documenting outcomes and delivering a powerfully engaging patient experience.
FDA-Clearance granted on March 7th, 2019
510K Reference Number: K180880
Device Name: DARI Health
Regulation Name: Measuring Exercise Equipment
Regulatory Class: Class II
Product Code: LXJ, System, Optical Position/Movement Recording
Classification Panel: Physical Medicine
Indications for Use: DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physical therapy, and the like.