Healthy.io, an Israeli medical technology company, has secured the US Food and Drug Administration (FDA) 510(k) approval for its smartphone-based Albumin-to-Creatinine Ratio (ACR) test to diagnose chronic kidney disease (CKD).
Healthy.io is involved in transforming smartphone cameras into a clinical-grade medical device, and the recent approval marks the second FDA clearance it has received following the approval of its at-home, smartphone-based 10-parameter urinalysis test kit, called Dip.io.
The company has secured a $60m (£49m) Series C funding round led by Corner Ventures, joined by Joy Capital and existing investors, Ansonia, Aleph and Samsung NEXT.
Healthy.io will use the proceeds to accelerate global expansion and product development
Healthy.io said that the FDA approval indicates that its smartphone-based ACR test is equivalent to lab-based testing and approves its use by healthcare professionals at any point of care.
The company has designed the test to enable any pharmacy, urgent care centre or health clinic to perform the test without investing in a table-top lab device, and facilitate immediate electronic medical record (EMR) connectivity through the automated smartphone scan.
With the new funding, the company plans to secure the FDA approval for its ACR test kit for at-home use and continue its product development.
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 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, publishing the results for its prenatal care and CKD testing products.
