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Healthy.io Brings Home FDA Nod for Smartphone-Based Test

The Tel Aviv, Israel-based company has also raised $60 million in a series C round. Healthy.io’s test can be used in the aid of diagnosing chronic kidney disease.

Healthy.io has developed an interesting use for smartphones. The Tel Aviv, Israel-based Company is turning the smartphone into a clinical-grade medical device to be used in the aid of diagnosing chronic kidney disease (CKD).

Healthy.io’s ACR test has received FDA clearance and in addition, the firm has 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 funding round will be used to accelerate Healthy.io’s global expansion and product development. Additionally, the company announced that a longtime leader in healthcare innovation, former executive vice president of Aetna Gary Loveman, PhD. will join its Board of Directors.

“The smartphone has the potential to be the great equalizer of healthcare,” said Yonatan Adiri, founder and CEO of Healthy.io. “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 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 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 UTIs or in prenatal care. Next, the company plans to continue the approval process for its ACR test kit for at-home use.

With the new funding, Healthy.io will continue its product development. The company recently announced a partnership with Boots UK, 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 in England.

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