Healthy.io
Definition
Healthy.io is an Israeli company founded in 2013 that develops technology turning a smartphone camera into a medical testing tool, allowing tests that once required a lab to be done at home.
The problem: a kidney test most people at risk don't take
About 80% of people at risk of kidney disease do not complete an annual urine test for the albumin-to-creatinine ratio (ACR), the standard test for early detection. According to the company, in the United States alone this means about 60 million untested people at high risk of kidney failure and related complications such as heart attack and stroke. Healthy.io, founded in 2013 by Yonatan Adiri, built a solution that turns a smartphone camera into a testing tool: the user photographs a test strip dipped in urine, and the app analyzes the colors and produces an immediate clinical result. Beyond the kidney test, the company also offers Minuteful for Wound, a camera-based digital tool for tracking wounds.
Minuteful Kidney: a historic FDA clearance
On 12 July 2022 Healthy.io received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for home use of Minuteful Kidney. It was the first time the FDA had cleared a smartphone camera-based home test for the albumin-to-creatinine ratio, on all common iOS and Android models. The regulatory clearance document itself (K210069) details the validation process the product went through with the FDA.
Rollout in the British NHS and in American insurance
In the United Kingdom, the National Health Service (NHS) adopted Minuteful Kidney as the leading tool for early detection of kidney disease, in a program involving about 540,000 people at risk, with estimated potential savings of 615 million pounds sterling, according to the company. In the United States, in partnership with leading insurers and in tests that included more than 100,000 members, the company reported an increase of up to 50% in testing rates among populations that had not been tested before. According to the company, the product's user satisfaction rate is about 98%.
Funding
Over the years the company has raised several funding rounds, including a Series D totaling $95 million ($45 million in February 2022 and another $50 million announced in May 2023), led by Schusterman Family Investments with the participation of Aleph and other existing investors.
FAQ ❓
What does Healthy.io actually do?
It turns a smartphone camera into a calibrated medical testing tool, allowing tests that required a lab, such as the urine albumin-to-creatinine ratio for detecting kidney disease, to be done at home.
What regulatory clearance did Minuteful Kidney receive?
510(k) clearance from the U.S. FDA in July 2022 for home use, the first time such clearance was given to a smartphone camera-based test.
Who uses Healthy.io's technology?
The British National Health Service (NHS) adopted Minuteful Kidney for early detection of kidney disease in about 540,000 people at risk; in the United States the company works with leading health insurers.
How much has Healthy.io raised?
In its Series D (2022 to 2023) it raised $95 million, led by Schusterman Family Investments.
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