FDA approves smartphone for testing urine
August 7, 2018
For the first time, the FDA has granted class II approval for a smartphone to carry out urine tests. Healthy.io is the first company in the world to enable the smartphone camera to be used as a clinical grade diagnostic device.
The Israeli firm has received class II US FDA approval for the product, part of of its expanding Dip.io digital health product portfolio.
Dip.io is a home-based, smartphone-enabled urinalysis kit that lets patients conduct clinical grade urine tests in the privacy of their own home.
Millions get their urine tested every day – pregnant women, those suffering from kidney disease, diabetes, high blood pressure and others – but doing it in the lab is time consuming and cumbersome. Conducting the same test in the comfort of one's home using a smartphone can improve patient outcomes enormously while potentially saving billions of dollars in healthcare expenditures through better access and prevention.
While other mobile health technology companies have been granted FDA approval, this is the first time the agency has cleared a device based solely on existing smartphone cameras for class II clinical claims.
"We are in the midst of the biggest economic value transition in history," said Yonatan Adiri, founder and CEO of Healthy.io. "One trillion dollars annually of inefficient healthcare spending in the USA alone are now starting to be captured by technology companies that specialise in transparent value creation for less resources. Healthy.io is proud to have its pioneering technology withstand the rigour 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."
The FDA approval marks the culmination of a strong growth period for Healthy.io. In April, a study initiated by the National Kidney Foundation and Geisinger, based on the Healthy.io adherence-as-a-service platform, demonstrated significant adherence improvement compared to standard of care.
Already commercialised in Europe and Israel where the product was approved in 2016, Healthy.io's home urine testing is set to be used by 100,000 people by the end of 2018 across patient pathways, with partners looking to shift more and more urine tests from the lab to the home.
"This approval opens the door for improved screening for kidney disease, a condition which affects over ten per cent of the population globally," said Joe Coresh, professor of epidemiology at Johns Hopkins 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. It is also a welcome tool helping improve diagnosis and awareness of chronic kidney disease. It's exciting to see the FDA applying its rigour and enabling the use of the smartphone for better patient care."
In the UK, Healthy.io has been selected for the NHS Innovation Accelerator as a key technology, and has been made available nationally through the G-Cloud procurement framework. In June, the Salford Royal NHS Foundation Trust launched an NHS first virtual renal clinic using Healthy.io to improve patient convenience and curb costs.
Healthy.io is currently expanding its medical selfie portfolio to standardised assessment of chronic wounds.