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Healthy.io
At Healthy.io, our technology helps people find the right moment to take a meaningful step towards managing their health by transforming the smartphone camera into a clinical-grade medical device to deliver healthcare at the speed of life. We are on a mission to bring lifesaving and cost-effective technology to people from all walks of life, regardless of race, ethnicity, gender, or location: everyone deserves equal access to key diagnostic testing.
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Minuteful Kidney 
By: Healthy.io
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FDA-cleared smartphone-enabled home albumin-to-creatinine ratio (ACR) test
An ACR test is currently recommended for the 75 million Americans at risk for Chronic Kidney Disease. Until Healthy.io's recent FDA clearance in July 2022, 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. Treating CKD and End Stage Renal Disease currently costs Medicare over $120 billion 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, 1 in 3 Americans is 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. Now with Minuteful Kidney™, people can 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.
- Minuteful Kidney™ is the first FDA-cleared smartphone-enabled home albumin-to-creatinine ratio (ACR) test, the standard of care for detecting Chronic Kidney Disease (CKD). 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.
- Healthy.io is transforming the smartphone camera into a medical device that can provide test results at critical moments and sync healthcare with the way people live. Our patented computer vision and deep learning algorithms - 49 granted patents in the US and globally and 23 pending patents - have unlocked the power of smartphone cameras to decentralize healthcare. At our core is a technology stack that makes all phone sensors see the same color, irrespective of lighting conditions and hardware. Additionally, our data driven UI/UX system design delivers 100% patient usability success. We are also fully integrated into EMRs, creating a seamless experience for providers. Minuteful Kidney™ is also the first FDA-cleared smartphone-powered home ACR test, and the first test to receive FDA clearance across all current iOS and Android smartphone devices. Our model is simple: If you can send a text, you can take a test.
- Laboratory & Diagnostics
- Released
- Kidney/Genito-urinary
- Patients
- Disease Management
- Handheld, Mobile App
- Nephrology
- Device, Software and Apps
- Home Care
- Digital Health Hub Finalist (2024)
- Direct to Consumer
- FDA Cleared, CE Mark
- As part of the FDA clearance process, Healthy.io partnered with leading US health plans in pragmatic trials serving more than 100,000 people. The results showed that the use of Minuteful Kidney™ raised testing adherence up to 50% among previously untested commercial populations irrespective of demographic and socio-economic differences. Similarly, a recent rollout in the UK showed that Healthy.io test kits raised test adherence from 0% to 50% among patients who had not done a urine test for kidney disease in the previous year.
- Yes
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Total Reviews: 1
Role: Physician
Regulatory Approval/ Qualifications
FDA Cleared 
CE Mark
Awards and Recognition
- Digital Health Hub Finalist (2024)