Skip nav to main content.

Medical Diagnosis by Smartphone

Using selfies as a diagnostic tool isn’t exactly a new thing. However, a new use…

  • August 25, 2018

Using selfies as a diagnostic tool isn’t exactly a new thing. However, a new use of Smartphones for urinalysis certainly is.

Recently, the U.S. FDA approved 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, according to Israeli firm, which produces the test. bills itself as the first company in the world to enable the Smartphone camera to be used as a clinical grade diagnostic device, with its Smartphone-enabled urinalysis kit now granted FDA clearance.

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.

Leave a Comment