Healthy.io gets FDA license for smartphone-based home kidney test
Urine analysis and wound care company on smartphones Healthy.io received FDA 510(k) certificate for home use for its Minuteful kidney injury test.
This test is used to identify an increased presence of a protein called albumin in the urine, which can early signs of chronic kidney disease. The kit includes test strips, sample cups and color palettes. Patients dip the test strip into their urine sample and take a picture of their strip along with the table using the company’s app to determine their albumin-to-creatinine ratio (ACR).
Of the company before 510(k) from 2019 removed the test for use by healthcare professionals at the point of care using the iPhone 7. It also received a clearance in 2018 for a similar urine test kit to detect glucose, specific gravity, blood, pH and protein, as well as qualitative nitrite detection.
“We have the experience, results, and regulatory reassurance to fundamentally change the way Americans track chronic diseases with the cameras on their smartphones,” said Healthy founder and CEO. .io Yonatan Adiri said in a statement.
“In fact, Minuteful Kidney is a digital antidote that can help people at risk to significantly reduce their chances of needing dialysis. We aim to bring our technology to millions of Americans everywhere. socioeconomic level, prevent CKD, reduce dialysis rates, and reduce healthcare costs.”
WHY IT IMPORTANT
According to CDC15% of adults in the US have chronic kidney disease, but many people don’t know they have it.
Early stage kidney disease usually no symptoms, and many patients are not diagnosed until the disease is more advanced. About two in a thousand Americans have end-stage kidney disease, requiring a kidney transplant or dialysis, according to NIH.
TREND TO BIGGER
Healthy.io has ended a $60 million Series C in 2019, a few months after the announcement Raise $18 million Series RED. In 2020, the startup launched a smartphone-based product for wound management and acquired Inui Health.
Other companies in the kidney care sector include Strive Health, landed 140 million dollars in a Series B funding round last year, and Monogram Health, closed Raised $160 million in 2021.