Israeli company Healthy.io, known for transforming the smartphone camera into a medical device, has received 510(k) clearance from the US FDA for home use of the Minuteful Kidney test.

This is the first time the FDA has granted clearance for a smartphone-powered home test to determine albumin-to-creatinine ratio (ACR).

An ACR test is recommended for the 75 million Americans at risk for chronic kidney disease (CKD). Until this clearance, the test could only be conducted by a medical practitioner. As a result, 60 million Americans – roughly 80% of at-risk patients – fail to complete their annual test.

This 510(k) clearance allows people to use their smartphone camera to conduct a urine test that identifies a specific protein in the urine called albumin, which is the standard of care for detecting early signs of CKD.

“We have the experience, results and regulatory assurances to fundamentally change how Americans monitor chronic conditions using their smartphone camera,” said Healthy.io CEO Yonatan Adiri. “In effect, Minuteful Kidney is a digital antidote that can help every person at-risk dramatically decrease their probability of undergoing dialysis. We look forward to bringing our technology to millions of Americans across all socioeconomic levels, preventing CKD, lowering rates of dialysis and reducing healthcare costs.”

Treating CKD and end-stage renal disease (ESRD) costs Medicare over $120bn annually. The condition is referred to as a silent killer, as it often doesn’t have symptoms until very late stages. According to the National Kidney Foundation, a third of Americans are at risk, including those with diabetes and hypertension, yet most don’t know they have the condition until it progresses to ESRD, eventually requiring dialysis and/or a kidney transplant.

The company partnered with US insurers as part of a clinical evaluation, serving more than 100,000 Americans rendering the technology ready for full commercial rollout.

The outcomes of US evaluations have shown that home testing with Minuteful Kidney raised testing adherence up to 50 per cent among previously untested populations irrespective of demographic and socio-economic differences.

Minuteful Kidney can promote early detection of CKD by allowing patients to take a clinical-grade ACR test at their preferred time and location, with a simple smartphone scan, without dongles or add-ons. Samples do not need to be sent to a lab and the results are immediate.

This clearance comes after Healthy.io was adopted by the National Health Service (NHS) in the UK as its leading AI tool enabling early warning of kidney degradation. As part of the service over the past 18 months, Minuteful Kidney has enrolled more than 540,000 people in the UK and saved the NHS 2.5 million hours of dialysis annually.

“Healthy.io has worked for almost a decade on a series of scientific breakthroughs that have facilitated a dialogue of trust with the FDA,” said Ron Zohar, chief product officer of Healthy.io. “The work conducted in collaboration with the leadership at the FDA’s Center for Devices & Radiological Health facilitated the development of AI innovation that will now deliver better digital health to the American public. We look forward to expanding our work with US payers and insurers in making sure every American with a smartphone can access this state-of-the-art technology.”

George Bakris, director of the Comprehensive Hypertension Center at the University of Chicago and the American Diabetes Association, added: “Millions of Americans are living with kidney disease, yet many don’t know they have the condition. An albumin test is required for proper diagnosis, and an important tool to monitor kidney health for those at risk. Healthy.io has provided an easy way to provide patients and clinicians with potentially life-saving information.”

The testing platform is essentially phone agnostic. The FDA said: “The image validation transfer system (IVTS) component of the Minuteful Kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.”

Healthy.io transforms the smartphone camera into a medical device to deliver healthcare. The company’s at-home urinalysis and digitised wound care services enable providers and healthcare systems to close gaps in access and care while increasing patient satisfaction. The company is based in Tel Aviv and has offices in Boston in the USA and London.