FDA Approves First Smartphone Camera-Based Device for Clinical Diagnostics

Posted July 27, 2018

In a first for the U.S. healthcare technology industry, the Food and Drug Administration (FDA) has granted Class II approval to a device that uses a smartphone-based camera to allow patients to conduct clinical-grade urine tests. The landmark approval comes as the increasing power of smartphone sensors, processing power, displays, and connectivity continues to push the boundaries of traditional medical devices and transform healthcare delivery.

The smartphone-based device, called Dip.io, was developed by Tel Aviv, Israel-based Healthy.io and was previously approved for use in Israel and in Europe in 2016. The device allows patients to test their urine at home for the presence of protein, glucose, and blood using a smartphone camera, app, dipstick, and colored reference board. A chatbot walks the patient through the testing process, and then the smartphone camera “reads” the test strip. This means that unlike other at-home testing kits, patients can get results right away and then share them with a clinician.

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

Healthy.io began a clinical trial in April in partnership with the National Kidney Foundation and Geisinger Health to study the use of Dio.io in people diagnosed with chronic kidney disease and high blood pressure. The results of that study are expected by the end of the year.

"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," said Yonatan Adiri, founder and CEO of Healthy.io, in a statement.