FDA Clears First Markerless Motion Analytic System

The FDA has granted 510(k) clearance to Scientific Analytics Inc.’s markerless DARI Health System.

The company claims the system, “Is the world’s first and only technology that delivers validated 3D kinematic and kinetic motion analytics without sensors, markers, or force plates. And it produces the reports within minutes of capturing the data.”

The system, according to FDA documents, allows a provider 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.”

The company stated in its FDA clearance document that DARI’s existing motion capture technology system has been utilized in non-clinical biomechanical research, fitness applications, and performance evaluation for many years. “Now there is a need for the development of its use in clinical applications.” stated an April 3, 2019 company press release.

Hospital for Special Surgery Collaboration

To develop those clinical applications, the company in an April 3, 2019 press release, also announced a collaboration with Hospital for Special Surgery (HSS) in New York.

DARI’s computer vision and biomechanical analysis technology, according to the company, “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 set new standards for full-body, dynamic motion analysis at population scale.”

Markerless Capture

The system is a “markerless,” three-dimensional human motion capture and analytical software system that uses off-the-shelf video cameras, off-the-shelf computer hardware, off-the-shelf motion analysis software, and proprietary DARI Health Software (consisting of DARI Connect, DARI Capture plug-in, DARI Insight Engine) to collect, quantify, and document full-body human kinematic and kinetics during patient movement.

Markerless means there are no position markers required for live capture or post-processing analysis. The system requires no contact with the patient, and poses no electrical, chemical, mechanical, thermal, or radiation safety concerns.

Motion are recorded in real-time, using a digital “skeleton” to identify joint center and segment data for the cervical spine, upper extremity, trunk, and lower extremity of the patient. The captured video can be viewed after the recording has ended or at some later point.

During movement, the system interfaces with the capture software, tracks all segments and joint centers as they move in all planes of motion. The collected data can then be used to calculate all kinematic and kinetic data produced during the recorded motion.

You can view a YouTube video of the system here.

Accessing Data

The data is kept and displayed in different report formats.

Providers can access patient biomechanical data remotely or on a local computer. There is no direct contact with the patient by the DARI system, and no energy is delivered to the subject at any point during the usage of the system.

Three-dimensional motion information is obtained from the subject through a video feed that is recorded and stored on a computer. The system’s Insight Engine is used for data presentation to the provider. The data are available from a remote, security-compliant server for remote evaluations by the provider.

The company says there are no statistically significant differences to “marker-based” systems in the clinically relevant joint angles being measured.