The US Food and Drug Administration (FDA) has granted class II approval for Healthy.io’s Dip.io Urinalysis, where a smartphone camera will be used as a clinical grade diagnostic device.
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. It is the first time the FDA has ever granted Class II approval for smartphone urine testing.
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 cleared a device based solely on existing smartphone cameras for Class II clinical claims. This ruling is an indication of the company’s impact on the digital health industry and expanding clinical value.
Healthy.io founder and CEO Yonatan Adiri said: “We are in the midst of the biggest economic value transition in history. One trillion dollars annually of inefficient healthcare spending in the US alone are now starting to be captured by technology companies that specialize in transparent value creation for less resources. Healthy.io is proud to have its pioneering technology withstand the rigor 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.”
Johns Hopkins Epidemiology Professor and chair of Healthy.io’s medical advisory board Joe Coresh said: “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. It is also a welcome tool helping improve diagnosis and awareness of chronic kidney disease. It’s exciting to see the FDA applying its rigor and enabling the use of the smartphone for better patient care.”
The landmark FDA approval marks the culmination of a strong growth period for Healthy.io. In April, a study initiated by the National Kidney Foundation (NKF) and Geisinger, based on the Healthy.io adherence-as-a-service platform, demonstrated significant adherence improvement compared to standard of care. Full details of the study will be published later this year.
Already commercialized in Europe and Israel where the product was approved in 2016, Healthy.io’s home urine testing is set to be utilized by 100,000 users by the end of 2018 across patient pathways, with partners looking to shift more and more urine tests from the lab to the home.
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 standardized assessment of chronic wounds.
Source: Company Press Release