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Devices Diagnostics FDA

 News Release - July 25, 2018

A Big Win for Digital Health: U.S. FDA Grants Landmark Class II Approval for Clinical Grade Smartphone Testing - Healthy.ios Urinalysis

Approval Helps Usher in Era of Medical Selfie, Leveraging Embedded Smartphone Cameras to Improve Patient Adherence and Outcomes and Curb Healthcare Expenditures

TEL AVIV, Israel, July 25, 2018 -- (Healthcare Sales & Marketing Network) --, the first company in the world to enable the smartphone camera to be used as a clinical grade diagnostic device, announced today that it received Class II U.S. Food and Drug Administration (FDA) approval for the first product of its expanding digital health product portfolio: is a home-based, smartphone-enabled urinalysis kit that lets patients conduct clinical grade urine tests in the privacy of their own home. It is the first time the FDA has ever granted Class II approval for smartphone urine testing.

Millions get their urine tested every day - pregnant women, those suffering from kidney disease, diabetes, high blood pressure and others - but doing it in the lab is time consuming and cumbersome. Conducting the same test in the comfort of one's home using a smartphone can improve patient outcomes enormously while potentially saving billions of dollars in healthcare expenditures through better access and prevention.

While other mobile health technology companies have been granted FDA approval, this is the first time the agency cleared a device based solely on existing smartphone cameras for Class II clinical claims. This ruling is an indication of the company's impact on the digital health industry and expanding clinical value.

"We are in the midst of the biggest economic value transition in history," said Yonatan Adiri, Founder and CEO of "One trillion dollars annually of inefficient healthcare spending in the U.S. alone are now starting to be captured by technology companies that specialize in transparent value creation for less resources. 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."

"This approval opens the door for improved screening for kidney disease, a condition which affects over 10% of the population globally. 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," said Prof. Joe Coresh, Professor of Epidemiology at Johns Hopkins and chair of's medical advisory board. "It's exciting to see the FDA applying its rigor and enabling the use of the smartphone for better patient care."

The landmark FDA approval marks the culmination of a strong growth period for In April, a study initiated by the National Kidney Foundation (NKF) and Geisinger, based on the adherence-as-a-service platform, demonstrated significant adherence improvement compared to standard of care. Full details of the study will be published later this year.

Already commercialized in Europe and Israel where the product was approved in 2016,'s home urine testing is set to be utilized by 100,000 users by the end of 2018 across patient pathways, with partners looking to shift more and more urine tests from the lab to the home.

In the UK, has been selected for the NHS Innovation Accelerator as a key technology, and has been made available nationally through the G-Cloud procurement framework. In June, the Salford Royal NHS Foundation Trust launched an NHS first 'virtual renal clinic' using to improve patient convenience and curb costs. is currently expanding its "medical selfie" portfolio to standardized assessment of chronic wounds.

About specializes in using state of the art computer vision to transform embedded smartphone cameras into clinical grade medical devices, ushering in the "era of the medical selfie." True to its mission to enable digitally enabled, decentralized care within the existing healthcare system, the company works alongside leading payers and providers worldwide to bring better care to the patient. Its first product family empowers patients to perform clinical-grade digital urinalysis testing from home with no quality compromise. Founder and CEO Yonatan Adiri is a World Economic Forum "Global Young Leader," and at the age of 26, was appointed the first Chief Technology Officer to an Israeli President, Shimon Peres. is an NHS Innovation Accelerator company, and a World Economic Forum Technology Pioneer.


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