Healthy.io has designed the test for pharmacies, urgent care centres, or health clinics to perform the test without a tabletop lab device
Image: FDA approval is based on the tumour response rate and durability of response. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
Healthy.io, an Israeli medical technology company, has secured 510(k) approval from the US Food and Drug Administration (FDA) for its smartphone-based Albumin-to-Creatinine Ratio (ACR) test to diagnose chronic kidney disease (CKD).
The company has also secured a $60m (£48m) Series C funding round led by Corner Ventures, joined by Joy Capital and all existing investors, Ansonia, Aleph and Samsung NEXT. The company plans to use the proceeds for global expansion and product development.
FDA approves the use of smartphone-based ACR test by healthcare professionals at any point of care
Healthy.io said that the recent approval marks the second FDA clearance after the approval for its at-home, smartphone-based 10-parameter urinalysis test kit, called Dip.io, last year. The approval indicates that the company’s smartphone-based ACR test is equivalent to the lab-based testing
The company said that it has designed the test to enable pharmacies, urgent care centres, or health clinics to perform the test without investing in a tabletop lab device and allow immediate electronic medical record (EMR) connectivity through an automated smartphone scan.
Healthy.io founder and CEO Yonatan Adiri said: “The smartphone has the potential to be the great equalizer of healthcare. To unlock this potential, companies must adhere to the highest clinical standards.
“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 has recently entered into a partnership with the National Health Service (NHS) in England for a new pharmacy evaluation, and retail pharmacies to distribute its Dip UTI test kits.
Furthermore, the company has collaborated with Johns Hopkins University and Geisinger Health in the US, and published the results for its prenatal care and CKD testing products.