July 27, 2018 Source: MobiHealthNews 165
Healthy.io, of Israel, gains FDA 510(k) approval for Dip.io, it's domestic urinalysis kit that transforms a smartphone into a clinical-standard diagnostic machine. It is the first and only smartphone-based urine analysis to be cleared as a Class 2 device.
“We are incredibly proud of being the first to achieve this landmark ruling,” CEO Yonatan Adiri told MobiHealthNews in an email. “It’s the highlight in a year that has seen us achieve so many of the key tasks we set out to achieve. With seven leading medical partners worldwide, including the UK National Healthcare System and a growing product portfolio, we’re set to meet 100,000 patients this year.”
The kit provides comprehensive instructions for home urine testing and disposable test strips and cups, including a novel feature of an array of patterns and colors that enables the smartphone camera to precisely decode the test strip overlooking any lighting or surroundings. This makes it stand out from the rest of the home-based lab kits by showing them the results instantly, they don't need to e-mail the lab.
Joe Coresh, professor of epidemiology at Johns Hopkins and chair of Healthy.io’s medical advisory board, said in a statement. “Dip.io home testing for protein, glucose, and blood in urine can be enormously helpful for patients. It is also a welcome tool helping improve diagnosis and awareness of chronic kidney disease.”
“We are in the midst of the biggest economic value transition in history,” Adiri, founder and CEO of Healthy.io, said in a statement. “Healthy.io is proud to have its pioneering technology withstand the rigor of FDA Class II trials and continues to pursue its mission of ushering in the era of the medical selfie — as it transforms embedded smartphone cameras into clinical-grade medical scanners.”By Ddu
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