Greater Manchester Digital Health Accelerator-supported company Healthy.io, has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its smartphone-based ACR test to be used in the aid of diagnosing chronic kidney disease (CKD), which affects over 35 million Americans.

As a global leader in turning the smartphone camera into a clinical-grade medical device, this is the second FDA clearance the company has received. The company also closed a $60 million Series C funding round led by Corner Ventures with participation by Joy Capital and all previous investors: Ansonia Holdings, Aleph, and Samsung NEXT.

Healthy.io has worked closely with a number of AHSNs – Health Innovation Manchester, North East North Cumbria, UCL Partners, Kent, Surrey, Sussex and Yorkshire & Humber AHSN.

Olivia Hind, Partnerships Director at Healthy.io, said: “The economic evaluation supported by Yorkshire & Humber AHSN has helped us to build a healthcare economic case and go to other areas demonstrating the financial savings and usability. It has also helped us build up our business case as we expand into the US.

“The AHSNs helped us to understand which care pathways to focus on, which geographical areas, which customers – whether it’s Clinical Commissioning Groups or Trusts, and that’s enabled us to fine tune our offering and products and secure additional NHS contracts”

The FDA clearance designates Healthy.io’s smartphone-based ACR test as substantially equivalent to lab-based testing and authorizes the use of the test by healthcare professionals at any point of care. It makes it possible for any pharmacy, urgent care center, or health clinic to perform the test without investing in a tabletop lab device. In addition, Healthy.io’s solution allows immediate electronic medical record (EMR) connectivity through the automated smartphone scan.

With the new funding, Healthy.io will continue its product development. The company recently announced a partnership with the NHS in addition to other retail pharmacies, placing its Dip UTI test kits in hundreds of pharmacies, allowing women to test and treat common UTIs, and announced a new pharmacy evaluation with the National Health Service (NHS) in England.