Reflexion Health’s Digital Medicine Therapy Tool Receives FDA Clearance

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San Diego-based company Reflexion Health announced that its motion-tracking based physical therapy tool Vera received FDA 510(k) clearance on October 30, 2015 (510(k) number K150462).

According to the Indications for Use Statement and the 510(k) Summary, Vera is a software system that uses the Microsoft Kinect technology to support physical rehabilitation of adults in the clinic and at home.  The 510(k) submission states that the Microsoft Kinect Sensor uses structured infrared light to determine the position of objects in its field of view in three dimensions including distance, or “depth,” from the sensor.

Reflexion’s FDA submission also notes that the Vera software provides medical professionals the tools to record video and track movements in 3D space in order to identify motion and count repetitions during patient participation with a prescribed exercise.  Data derived from motion tracking as well as the recorded video can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise.

The 510(k) submission further states that, more specifically, the Vera system includes rehabilitation exercises for legs with audio-visual feedback and graphic movement representations for patients, as well as remotely accessible patient performance videos.  Patient assessment, exercise guidance, and approval by a medical professional are required prior to use.

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According to the Company’s website, Reflexion is currently partnering with the Cleveland Clinic and the Brooks Rehabilitation Center in Jacksonville, Florida to deliver Vera to patients recovering from joint replacement surgeries.  A press release from the Brooks Rehabilitation Center regarding the partnership can be found here.  A demonstrative picture from the press release is shown above.  According to another press release, Reflexion has also received a $1 million grant from the Centers for Disease Control and Prevention to use Vera in fall prevention for seniors.  As part of this grant, the technology is currently employed in two senior populations in San Diego, California and Fearrington, North Carolina. A video of the Vera software can be accessed below.

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