Smart Autorefractors from Smart Vision Labs Approved for CE Marc

Smart Vision Labs, a maker of portable and smart autorefractors, announced today that SVOne has received CE mark approval.

New York, NY – March 7, 2016 – Smart Vision Labs, a maker of portable and smart autorefractors, announced today that SVOne has received CE mark approval which grants the company entitlement to market and sell the device in European countries. SVOne, a handheld Shack-Hartmann wavefront aberrometer, accurately measures objective refractive error in children and adults. In clinical studies, SVOne has been shown to be as accurate as much larger, legacy desktop autorefractor units.1 SVOne’s technology and platform address the unmet vision needs of millions of people.

“The CE mark is a significant step forward in the commercialization of SVOne in Europe,” said COO and co-founder Marc Albanese. “We’ve had a lot of interest from this market. With the CE Mark, our company’s mission to make vision care globally accessible will be even more attainable.”

The company recently released two next-generation products, SVOne Enterprise and SVOne Pro, which extend the reach of the SVOne product line. SVOne Enterprise features self-guided refraction technology, combining the power of mobile computation, precision optics, and connectivity. SVOne Pro is an upgraded version of the company’s core handheld technology with an increased range of power that covers the vision needs of 99% of the population: the sphere range is -14.00 to +14.00 diopters, and the cylinder range is -7.00 to +7.00 diopters.

SVOne, an FDA Class 1 exempt device, weighs less than 1 pound, and is suitable for use in any clinical setting. The smart autorefractors’ portability makes it an ideal tool in nonclinical settings as well, while its price point makes it accessible to the average clinician. Data from the device can be stored on a HIPAA-compliant cloud platform and extends the versatility of SVOne for use in telemedicine medicine programs.

 

1 Ciuffreda KJ, Rosenfield M. Evaluation of the SVOne: a Handheld, Smartphone-Based Autorefractor. Optometry and Vision Science. 2015;92(12):1113-1139

 

Company Contact:

Jessie Tang

jessie@smartvisionlabs.com

212.796.6124 x7002

 

Smart Vision Labs
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Floor 7, Suite 2
New York, NY 10010

212-796-6124
info@smartvisionlabs.com

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