NEW YORK (360Dx) – Healthy.io announced today that the US Food and Drug Administration has granted 510(k) clearance for its smartphone-enabled urinalysis kit called Dip.io.
The kit allows patients to conduct clinical grade urine tests at home, and FDA's clearance of Dip.io "opens the door for improved screening for kidney disease," said Joe Coresh, a professor of epidemiology at Johns Hopkins University and chair of Healthy.io's medical advisory board. "Dip.io home testing for protein, glucose, and blood in urine can be enormously helpful for patients."
The Dip.io technology uses a smartphone's camera to capture high-quality images of a patient's urinalysis results and immediately send it off for clinical diagnosis.
The test is commercially available in Europe and in Israel, where the product was approved in 2016. Health.io, which is based in Tel Aviv, Israel, has partnered with Geisinger and the National Kidney Foundation to run clinical trials on Healthy.io's technology platform to evaluate its use for detecting chronic kidney disease in patients with high blood pressure. A study with results from the trial will be published later this year, Healthy.io said.
The company added that it is expanding its technology portfolio to standardized assessment of chronic wounds.