- Healthy.io, a company that turns the smartphone camera into a clinical-grade medical device, announced that it received 510(k) clearance from the FDA and raised $60 million
Healthy.io — a company that is known for turning the smartphone camera into a clinical-grade medical device — recently announced that 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.
This is the second FDA clearance that Healthy.io received. And the company also closed $60 million in Series C funding led by Corner Ventures with participation by Joy Capital and all previous investors Ansonia Holdings, Aleph, and Samsung NEXT. This round of funding will be used for accelerating Healthy.io’s global expansion and product development. The company also announced that former Aetna EVP Gary Loveman, Ph.D. is joining the Board of Directors.
“The smartphone has the potential to be the great equalizer of healthcare,” said Healthy.io founder and CEO Jonathan (Yonatan) Adiri. “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 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. And it makes it possible for any pharmacy, urgent care center, or health clinic to perform the test without investing in a tabletop lab device. Plus Healthy.io’s solution allows immediate electronic medical record (EMR) connectivity through the automated smartphone scan.
“Today’s health system doesn’t make it easy for patients to get the care they need. Healthy.io is tackling this problem by meeting patients where they are, on their smartphones, and turning smartphone cameras into a clinical-grade medical device,” added Michael Eisenberg, a general partner at Aleph. “We are proud to support a company that can meet the highest FDA standards, while creating products that make life easier and more convenient for patients.”
Last year, Healthy.io had received clearance for its at-home smartphone-based 10 parameter urinalysis test kit called Dip.io, which can be used in testing for UTIs or in prenatal care. And the company plans to continue the approval process for its ACR test kit for at-home use.
With this round of funding, Healthy.io plans to continue its product development. And 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 and allowing women to test and treat common UTIs. Plus the company announced a new pharmacy evaluation with the National Health Service (NHS) in England.
In the U.S., Healthy.io has partnered with Johns Hopkins University and Geisinger Health and published strong results for its prenatal care and CKD testing products.
“Today, too many patients face barriers to care, leading to missed appointments, undiagnosed conditions, and increased visits to the emergency room or hospital. Healthy.io is establishing itself as a leader in a new world of broader, decentralized access to care without compromising on clinical quality,” added Loveman. “With this FDA clearance, Healthy.io adds a critical test to its portfolio in the U.S., which can make ACR testing dramatically more accessible and convenient, leading to a big difference in the management of at-risk populations.”