Healthy.io gets FDA approval for a mobile-based home urine test
Tel Aviv based startup, Healthy.io is making use of computer vision algorithms, artificial intelligence, and a smartphone’s built-in camera to run lab-standard urine tests.
Israeli health care system is well known worldwide for giving the best healthcare solutions. It has qualified specialist and the country is ranked among the top for its eHealth innovations. Israeli healthcare startups are making a mark in the global digital health market by entering numerous accelerators cohorts and participating in numerous inter-country cooperation programs.
Tel-Aviv based health startup Healthy.io has come up with the latest innovation of a home urine test kit that has been approved by FDA and now will be used in Israeli. The kit uses computer vision algorithms, a smartphone that has an inbuilt camera and artificial intelligence to run this urine test that is lab-standard. This health start-up is based in Tel Aviv has received class II US FDA approval to use this smartphone kit in the country.
The test kit contains a dipstick that is designed to detect ten different parameters which include chronic illness, pregnancy-related complications and a range of infections.
Patients are required to use the mobile phone camera to scan the strip where they will receive their results instantly through the app.
The class II FDA approval is only given to paramedical and medical devices that require minimal supervision and has direct health implications. This is the first time FDA is approving a third party device which is being distributed by Healthy.io.
“We are incredibly proud of being the first to achieve this landmark ruling,” CEO Yonatan Adiri said in a statement. It’s the highlight in a year that has seen us achieve so many of the key tasks we set out to achieve. With seven leading medical partners worldwide, including the UK National Healthcare System and a growing product portfolio, we’re set to meet 100,000 patients this year.”
“We are in the midst of the biggest economic value transition in history,” Adiri, founder, and CEO of Healthy.io said in a statement. “One trillion dollars annually of inefficient health care spending in the US alone are now starting to be captured by technology companies that specialize in transparent value creation for fewer resources. Healthy.io is proud to have its pioneering technology withstand the rigour of FDA Class II trials and continues to pursue its mission of ushering in the era of the medical selfie — as it transforms embedded smartphone cameras into clinical-grade medical scanners.”
Patients will now have a clinical grade diagnostic device straight from their smartphones which is the only smartphone device to pass the clearance stage.
The kit contains all the guidelines on how to use it and has testing cups and disposable test strips. This kit will minimize trips patients have to see the doctor especially those that have kidney diseases.
The healthcare system in Israeli has received a major boost by securing FDA 510(k) clearance for Dip.io.
Image credit: www.healthy.io