• FDA Clearance for myVisionTrack™

    Posted on March 24, 2013 by in Bulletin Board

     

    FOR IMMEDIATE RELEASE

     

     For more information:

    Mike Bartlett

    (214) 989-7130

    mike.bartlett@myvisiontrack.com

    Vital Art and Science Receives FDA Clearance for myVisionTrack™ Medical Device that Monitors Retinal Diseases

    DALLAS, TX. (April 5, 2013) – Vital Art and Science Inc. (VAS) has received U.S. Food and Drug Administration (FDA) clearance to market myVisionTrack™, a prescription-only medical device that enables patients with retinal diseases to monitor their vision function between regular visits to their eye-care professional to help ensure they obtain timely care and treatments.

    Using a proprietary patented shape discrimination hyperacuity (SDH) test, myVisionTrack™  enables patients to regularly assess their vision function. The device stores test results, tracks disease progression and automatically alerts a health care provider if it suspects significant deterioration of visual function in the patient.

    Age-related macular degeneration (AMD), diabetic retinopathy (DR) and other retinal diseases afflict more than 40 million people in countries with advanced health care systems.  Roughly 13 million people suffer from these diseases in the United States. During the past decade, new therapies have been developed for these degenerative eye diseases, but timely diagnosis and treatment are critical to their effectiveness.

    Clinical studies demonstrate that myVisionTrack’s shape discrimination hyperacuity test has comparable or higher sensitivity and specificity as compared to clinically available standard visual function tests for detecting advanced maculopathy from high-risk moderate maculopathy.

    myVisionTrack can be used in a physician’s office or at home by patients with maculopathy to help track disease progression, detect disease condition changes for earlier intervention and document treatment effects. Research confirms high satisfaction and compliance rates among patients able and willing to self-test at home with myVisionTrack.

    Vital Art and Science Inc. was founded in 2006 by a multi-disciplinary team with extensive expertise in ophthalmology, electronics, software and business development to identify, advance and commercialize innovative home diagnostics for treatable chronic diseases. VAS’s strategy has been to leverage the unique strengths of the Dallas/Fort Worth area universities and research facilities, as well as local electronic, telecommunications and health care companies.

    According to Mike Bartlett, Vital Art and Science Inc. President, the company is seeking strategic partnering opportunities for marketing and distribution of myVisionTrack™.  Pricing has not yet been determined.

    More information about myVisionTrack™ can be found at www.myvisiontrack.com.

    © 2013, Administrator. All rights reserved.

One Responseso far.

  1. [...] FDA has granted Class II prescription-only 510(K) clearance for an iPhone-enabled vision test. The software, called myVisionTrack, was developed by Vital Art [...]

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myVisionTrack™ now FDA Cleared!

myVisionTrack™ now FDA Cleared!

Vital Art and Science Receives FDA Clearance for myVisionTrack™ Medical Device that Monitors Retinal Diseases

DALLAS, TX. (April 5, 2013) – Vital Art and Science Inc. (VAS) has received U.S. Food and Drug Administration (FDA) clearance to market myVisionTrack™, a prescription-only medical device that enables patients with retinal diseases to monitor their vision function between regular visits to their eye-care professional to help ensure they obtain timely care and treatments.

Read More about the Press Release HERE