Emagine Solutions Receives FDA 510(k) Clearance for VistaScan Mobile Ultrasound

By News Release

Emagine Solutions Technology, a medical software device company in Tucson, Arizona, has received clearance from the U.S. Food & Drug Administration (“FDA”) to market its VistaScan mobile ultrasound platform.

The VistaScan platform transforms a clinician’s cell phone or tablet into a portable ultrasound solution. The system consists of compatible FDA cleared ultrasound probes that interface with the VistaScan software application. VistaScan’s proprietary patent-pending Dynamic Precise Point Measuring System enables a healthcare provider to maximize the accuracy of a mobile device's touchscreen to make highly precise, to-the-pixel measurements on the ultrasound image, thereby increasing diagnostic performance and speed.

“The velocity and complexity of modern medicine is becoming overwhelming, and putting the power of ultrasound into the pockets of clinicians so they can use it for real time diagnosis right at the bedside is liberating and transformative,” commented Dr. Berndt Schmit, Section Chief of Emergency Radiology at Banner University Medical Center at the University of Arizona and President of Humanitarian Radiology Development Corps.

Emagine Solutions Technology has already won a number of accolades prior to its launch of VistaScan, including grant funding from National Science Foundation and Roddenberry Foundation, the Flinn Foundation Bioscience Entrepreneurship award, National AURP Award, and was a Governor’s Celebration of Innovation Finalist this year. The company is also a Pipeline Angels investment portfolio company.

“Receiving FDA clearance is excellent validation of our technology and demonstrates the role handheld ultrasound will play in enhancing patient care,” commented Courtney Williams, Co-founder and CEO of Emagine Solutions Technology.

Emagine Solutions Technology is a certified Women’s Business Enterprise by the Women’s Business Enterprise Council and was founded to expand access to diagnostic ultrasound technology, particularly in the area of women’s health.

Photo credit: Tech Parks Arizona

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Emagine Solutions Receives FDA 510(k) Clearance for VistaScan Mobile Ultrasound.  Appl Radiol. 

By News Release| February 25, 2020

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