Cell Phone Urine Test Kit Receives FDA Approval

Healthy.io's technology uses computer vision algorithms, artificial intelligence and the built-in camera of a smartphone to perform urine tests in the laboratory. The kit of urine samples provided by the company includes a strip capable of detecting ten different parameters, including a range of infections, chronic diseases and pregnancy-related complications. Patients can scan the band using their cell phone's camera to receive instant results through an app.

Healthy.io urine test kit Photo: PR

FDA Clbad II approval is granted to medical and paramedical devices having direct implications on the This is the first time the FDA has granted such an authorization for a medical device based on optical equipment manufactured and distributed by a third party, said Healthy.io founder and CEO, Yonatan Adiri, during a telephone interview with Calcalist. Thursday.

The FDA's approval may serve as a precedent for other companies using ever-improving camera technologies available on mobile phones to create accessible household medical devices for patients, Adiri said.

Founded in 2013, Healthy.io has raised $ 15 million so far from Quantum Pacific International Ltd., a company owned by Israeli businessman Idan Ofer. The company has some 40 employees in its offices in Tel Aviv, London and New York.

In April, Healthy.io announced a partnership with the American National Kidney Foundation and Geisinger Health System, based in Pennsylvania, to launch a clinical trial on technology in Geisinger patients.

The product of Healthy.io has already been approved by health agencies in Israel and the United Kingdom, and the company aims to reach 100,000 active users by the end of the year, said in a statement.