Israeli diagnostic solutions developer Healthy.io has received 510(k) clearance from the US Food and Drug Administration (FDA) for the use of its smartphone-based albumin / creatinine ratio (ACR) test to diagnose chronic kidney disease (CKD).
The Healthy.io test can be performed at pharmacies, urgent care centres and health clinics, eliminating the need for a tabletop lab device.
Furthermore, the test can also facilitate immediate connectivity to electronic medical record (EMR) by using the automated smartphone scan.
The company said that the FDA clearance, which allows point-of-care use, recognises that its test is ‘substantially equivalent’ to laboratory testing.
Previously, the US regulator cleared the company’s smartphone-based, ten parameter urinalysis test kit called Dip.io for at-home use to detect urinary tract infections (UTIs) or in prenatal care.
The company is also seeking approval for at-home use of the ACR test kit.
Healthy.io founder and CEO Yonatan Adiri said: “The smartphone has the potential to be the great equaliser of healthcare. To unlock this potential, companies must adhere to the highest clinical standards.
“Our second FDA clearance and additional funding allow 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.”
The company intends to use the proceeds for product development and to speed up global expansion.
Recently, Healthy.io partnered with the UK National Health Service (NHS) and additional retail pharmacies to deploy its Dip UTI test kits for testing common UTIs in women.
The company also partnered with NHS England for a new pharmacy assessment.
Furthermore, it collaborated with Johns Hopkins University and Geisinger Health in the US to evaluate its prenatal care and CKD testing products.
Healthy.io has also appointed Aetna’s former executive vice-president Gary Loveman to its board of directors.