Health Canada Approves Smartphone-based Autorefractor
Wednesday, May 25 2016 | 00 h 00 min | News
Smart Vision Labs, maker of portable, smart autorefractors, successfully registered the SVOne Pro autorefractor in Canada as a Class II medical device, and received a Canadian Medical Device License through Health Canada.
The SVOne Pro is a handheld Shack-Hartmann wavefront aberrometer for accurately measuring objective refractive error in children and adults.
“Receiving our Canadian Medical Device License is a significant step forward in the commercialization of SVOne in Canada,” said COO and co-founder Marc Albanese. “We’ve had a lot of interest from this market. With the Health Canada approval, our company’s mission to increase access to vision care globally will be even more attainable.”
An evaluation of the SVOne by Drs. Ciuffreda and Rosenfield of SUNY College of Optometry was published in the December 2015 issue of Optometry and Vision Science. The SVOne was compared with retinoscopy, subjective refraction and two commercially available autorefractors in 50 visually normal young adults.
The results showed that the SVOne aberrometer provided measurements “not significantly different from other subjective and objective procedures,” and that the SVOne is “valuable for vision screenings, as well as examinations taking place outside the clinical office.”
