FDA clears the first smartphone camera-based clinical grade at-home urine test

An Israel-based Healthy.io has received FDA 510(k) clearance for Dip.io, a home-based urinalysis kit that transforms the smartphone into a clinical-grade urine diagnostic device. It is the first smartphone-based urine test to secure clearance as a Class 2 device.

Millions of people around the globe such as pregnant women, those suffering from kidney disease, diabetes, high blood pressure and others are required to get their urine tested very frequently- but going to the lab every day is very cumbersome and time-consuming. Dip.io let patient perform urine test in the privacy of their home with results that are equivalent to a hospital-based lab urine test.

The Dip.io kit comes with a cup, dipsticks and patented colorboard. The user simply opens the smartphone apps and is guided step-by-step through the kit by the chatbot nurse named Emily. After peeing in the cup, the user dips the stick and places it on the colorboard. After a lapse of 60 seconds the dipstick and the board are scanned, the image normalized, and data points are sent to the cloud platform to be analyzed and turned into clinical results.

The results are conveyed to the health care provider or directly stored as a part of the patient’s medical record.

The app is straightforward to use as apparent from the tagline “If you can text, you can test,” and has achieved more than 99 percent usability across age groups ranging from 18-80 because of rapid prototyping and repeated user testing. 

The dipstick measures 10 parameters including blood, protein, and glucose in urine and is enormously useful for patients with chronic kidney disease, diabetes, and high-risk pregnancies.

The FDA approval is based on the demonstration of the significant rise in the use of the Dip.io platform by patients of chronic kidney disease as reported by the results of a study initiated by the National Kidney Foundation (NKF) and Geisinger Health.

The Dip.io technology has already been approved by the National Health Trust of UK and is nationally available through the G-Cloud procurement framework. It is also a part of NHS first 'virtual renal clinic' to improve patient convenience and improve cost.

Already commercialized in Europe and Israel since 2016, it is estimated that it will be utilized by 100,000 users by the end of 2018 through different patient pathways, shifting more and more urine testing from labs to homes.

Healthy.io is currently working on expanding the technology for at home assessment of chronic wound through ‘medical-selfies.’

Arming patients with the capability to conduct the critical tests at home with the same accuracy as the lab will curb the tide of many chronic diseases, simplify their daily routine and bring down the healthcare cost significantly.

Press Release

Healthy.io homepage

National Kidney Foundation study

Ob/Gyn Updated Facebook page

Here is a short video about how the product works

Here is an animation describing the company’s intention behind developing the product

Healthy IO (Full Version) from Peepshow on Vimeo.