Arizona Start-Up Receives 510(k) Clearance for Mobile Ultrasound

February 25, 2020

Emagine Solutions Technology cleared to market VistaScan platform.

Today, Arizona-based medical software device company Emagine Solutions Technology received 510(k) clearance from the U.S. Food and Drug Administration for its VistaScan mobile ultrasound platform that turns a provider’s cell phone or tablet into a portable solution.

“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,” said Berndt Schmit, M.D., section chief of emergency radiology at Banner University Medical Center at the University of Arizona and Humanitarian Radiology Development Corps president, in a statement.

According to company information, the platform costs more than 10 times less than a standard ultrasound machine and pairs compatible FDA-cleared ultrasound probes with the VistaScan software application. After downloading the VistaScan app and plugging in one of the three existing probes, clinicians can begin scanning. Through the propriety patent-pending Dynamic Precise Point Measuring System, healthcare providers can use their mobile device’s touchscreen to make precise, pixel-level measurements of an ultrasound image, facilitating diagnostic performance and speed. In addition, providers have several hours of scanning capability without a need to recharge.

Initial applications are expected to be in obstetrics.

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