NEW YORK – Healthy.io said today that the US Food and Drug Administration has granted clearance for its smartphone-based albumin-to-creatinine ratio (ACR) test to diagnose chronic kidney disease.
Tel Aviv, Israel-based Healthy.io said that it has also closed a $60 million Series C funding round to accelerate global expansion and product development. Corner Ventures led the funding round, which involved participation by Joy Capital and previous investors Ansonia Holdings, Aleph, and Samsung Next.
In 2018, the FDA cleared Healthy.io's at-home, smartphone-based 10 parameter urinalysis kit, Dip.io, to test for urinary tract infections and for use in prenatal care.
"Our second FDA clearance and additional funding allows us to expand access to critical tests and care beyond our first 100,000 patients in Europe and Israel, making it a reality for millions of Americans suffering from diabetes and hypertension who are at risk for chronic kidney disease," Healthy.io's Founder and CEO Yonatan Adiri said in a statement.
The new FDA clearance designates Healthy.io's test as substantially equivalent to lab-based testing and authorizes use of the test by healthcare professionals at the point of care, the firm said. The regulatory clearance makes it possible for pharmacies, urgent care centers, and health clinics to perform the test. Further, using an automated smartphone scan, its system allows connectivity to electronic medical records.
Healthy.io also said that it plans to pursue regulatory approval of the ACR test kit for use as a home-based test. In February, it raised $18 million in Series B funding to support scaling up the at-home testing service.
The company recently announced a partnership with the UK-based National Health Service and retail companies, enabling placement of its Dip UTI test kits in pharmacies. In the US, Healthy.io has worked with Johns Hopkins University and Geisinger Health to publish results for its prenatal care and chronic kidney disease testing products.
The firm said today that it has appointed Gary Loveman, former executive vice president of Aetna, to its board of directors.