The Food and Drug Administration (FDA) has granted Class II approval to a first-of-its-kind, home-based urinalysis kit, Dip.io. This is the first time the Agency has granted Class II approval for smartphone urine testing.
The Dip.io kit works in tandem with existing smartphone cameras and a dedicated app. It was developed by Healthy.io, a company that specializes in image recognition and artificial intelligence with the goal of “ushering in the era of the medical selfie.”
After dipping a provided dipstick into urine, Dip.io users take a picture of the dipstick in front of a color board. Once the picture is taken, the results are sent to the user’s physician immediately through the app. The Company states that the dipstick measures 10 parameters which indicate a range of infections, chronic illnesses and pregnancy-related complications. They also claim that their computer vision algorithms and unique calibration method overcomes different lighting conditions, allowing for accurate dipstick reading.
“This approval opens the door for improved screening for kidney disease, a condition which affects over 10% of the population globally. Dip.io home testing for protein, glucose and blood in urine can be enormously helpful for patients,” said Joe Coresh, Professor of Epidemiology at Johns Hopkins and chair of Healthy.io’s medical advisory board.
For more information visit Healthy.io.