ACR (Healthy.io)

Healthy.io has received 510(k) clearance from the FDA for its smartphone-based ACR test to be used in the aid of diagnosing chronic kidney disease. A press release reports that this is the second FDA clearance the company has received. Additionally, 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.

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

Last year, the company received clearance for its at-home, smartphone-based 10 parameter urinalysis test kit, called Dip.io, that can be used in testing for urinary tract infections (UTI) or in prenatal care. Next, the company plans to continue the approval process for its ACR test kit for at-home use.

Yonatan Adiri, founder and CEO of Healthy.io, comments: “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.”

The funding round will be used to accelerate Healthy.io’s global expansion and product development. Additionally, the company announced that longtime leader in health care innovation, former executive vice president of Aetna Gary Loveman will join its Board of Directors.

The company also 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.