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Healthy.io Receives FDA Clearance for Smartphone-Based Home Kidney Tests

Healthy.io Receives FDA Clearance for Smartphone-Based Home Kidney Tests

Smartphone wound care and urine testing company Healthy.io has received 510(k) clearance from the FDA for home use of its Minuteful Kidney Damage Test.

The test is used to determine the increased presence of a protein called albumin in the urine, which can be an early sign of chronic kidney disease. The kit includes a test strip, sample cup, and color chart. Patients dip the test strip into the urine sample and take a photo of the strip next to the whiteboard using the company’s albumin-to-creatinine ratio (ACR) app.

The company’s previous 510(k) from 2019 approved the tests for use by healthcare professionals at the point of care using an iPhone 7. It also received authorization in 2018 for a similar urine test kit to detect glucose, gravity specific, blood, pH and proteins, as well as the qualitative detection of nitrites.

“We have the experience, results and regulatory assurance to fundamentally change the way Americans monitor chronic conditions using their smartphone camera,” said Yonatan Adiri, founder and CEO of Healthy.io.

“In fact, Minuteful Kidney is a digital antidote that can help anyone at risk drastically reduce the likelihood of undergoing dialysis. We look forward to bringing our technology to millions of Americans across all socioeconomic levels, preventing CKD, lowering dialysis rates, and reducing healthcare. costs”.


According to the CDC, 15% of American adults have chronic kidney disease, but many people don’t know they have it.

Early-stage kidney disease usually has no symptoms, and many patients are not diagnosed until the condition is more advanced. About two in every thousand Americans have end-stage kidney disease, which requires a kidney transplant or dialysis, according to the NIH.


Healthy.io concluded a $60 million Series C round in 2019, months after announcing an $18 million Series B raise. In 2020, the startup launched a smartphone-based wound management product and acquired Inui Health.

Other companies in the kidney care industry include Strive Health, which raised $140 million in a Series B funding round last year, and Monogram Health, which closed on a $160 million raise in 2021.

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