FDA approves smartphone camera–based dipstick product

Healthy.io, based in Tel Aviv, Israel, has obtained U.S. Food and Drug Administration (FDA) marketing clearance for its first digital dipstick kit offering. The Dip.io is advertised on the company’s website as having the accuracy of “the standard lab-based urinalysis analyzer.”

The dipstick is being marketed in Europe and is certified by CE and International Organization for Standardization (ISO) 13485 for sale in the European Union. The urinalysis dipstick includes 10 determinations, including indicators for possible CKD, on the strip.

With the FDA nod, Healthy.io stated in its news release: “This approval opens the door for improved screening for kidney disease, a condition which affects over 10 percent of the population globally. 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.”

According to Josef Coresh, MD, PhD, professor of epidemiology at Johns Hopkins Medicine and chair of Healthy.io’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 dipstick uses “computer vision algorithms” and a “unique calibration method” to ensure accurate reading and interpretation of results, accounting for the many different smartphone cameras available and “infinite lighting conditions,” according to the company’s website.

A photo of the dipstick with its color changes as test results will then be automatically sent to a patient’s electronic medical record so a clinical professional can follow up.

September 2018 (Vol. 10, Number 9)