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FDA clears first smartphone-powered home kidney test - Minuteful Kidney ~$218M raised across four venture rounds 15+ NHS trusts deploy AI-powered digital wound care Founded 2013 in Tel Aviv by Yonatan Adiri Series D led by Schusterman Family Investments A modified kidney test flew to the International Space Station FDA clears first smartphone-powered home kidney test - Minuteful Kidney ~$218M raised across four venture rounds 15+ NHS trusts deploy AI-powered digital wound care Founded 2013 in Tel Aviv by Yonatan Adiri Series D led by Schusterman Family Investments A modified kidney test flew to the International Space Station
Company Profile  /  Digital Health  /  Tel Aviv · Boston · London

Healthy.io

The company that turned the camera in your pocket into a clinical-grade medical device - running lab-quality urine tests at home and measuring wounds with AI.

Founded 2013 Smartphone Diagnostics FDA Cleared ~110 Employees
Healthy.io logo
HEALTHY.IO — The wordmark of a company that argues the most advanced diagnostic device most people own is already in their hand.
What it does

Healthcare at the speed of life

Colorimetric analysis, computer vision and AI, wrapped inside something a patient can do alone in a bathroom in a few minutes.

The clinical laboratory has barely changed in half a century - a sample, a courier, a machine, and a wait. Healthy.io started in 2013 with a different premise: the smartphone camera, calibrated correctly, is precise enough to read a diagnostic test. Pair a printed color-calibration board with a dipstick and an app, and the phone can correct for any camera and any lighting to deliver a reading that stands up to a central lab.

That idea now spans two businesses. The first is at-home urinalysis - tests for chronic kidney disease, urinary tract infections and pregnancy that patients run themselves and that route them toward treatment. The second is digital wound care, where clinicians photograph a wound and let AI produce a consistent 3D measurement, flagging the ones that are not healing. Both share the same core conviction: move the point of care to where the patient already is.

"Healthy.io has worked for almost a decade on a series of scientific breakthroughs that have facilitated a dialogue of trust with the FDA." Ron Zohar · Founding team member & Chief Product Officer
2013
Founded, Tel Aviv
~$218M
Total raised
15+
NHS trusts using it
1st
FDA home ACR test
The problem & the customer

Preventative care only works if people show up

They often don't. Healthy.io's answer was not a better clinic - it was no clinic at all.

Kidney disease is silent until it isn't. By the time symptoms appear, a patient may be headed toward dialysis. The recommended annual screening - a urine albumin-to-creatinine ratio - is cheap, but it requires people to travel to a lab, and millions never do. That gap is worst among rural and underserved populations, exactly the members health plans most want to reach.

So Healthy.io does not sell to individuals at retail. It sells to the systems responsible for those patients: health insurers, provider groups and national health services. A plan mails a member a box; the member runs the test; the result flows back into the record. In the UK, more than fifteen NHS trusts use its wound platform, developed in line with NHS England's National Wound Care Strategy. The buyers are institutions - the beneficiaries are patients who would otherwise be missed.

The whole pitch in five words: lab-quality accuracy, home-testing convenience. Healthy.io company positioning
Products & services

Three products, one camera

A urinalysis platform that became a family of tests, plus an AI wound-management suite for clinicians.

2022Kidney

Minuteful Kidney

Smartphone-powered home test measuring the urine albumin-to-creatinine ratio to catch early chronic kidney disease. The first smartphone-powered home ACR test to earn FDA 510(k) clearance.

2020UTI

Minuteful UTI

At-home urinary tract infection test. Snap a photo of a dipstick against the color board; colorimetric analysis and computer vision turn the camera into a clinical-grade device and connect patients to treatment.

2019Wound

Minuteful for Wound

Digital wound management - app, web portal and clinical dashboard - using AI-powered 3D measurement and tissue-type detection to track chronic wounds and flag those that are deteriorating.

2018Platform

Digital urinalysis platform

The core technology stack cleared as a Class II clinical diagnostic device - the calibration, computer vision and AI that every Minuteful test is built on.

Business model & edge

Regulation isn't the obstacle. It's the moat.

Where most healthtech promises to disrupt, Healthy.io spent years earning clearances before asking a single patient to trust it.

The revenue model is B2B2C. Health plans and health systems pay to deploy the tests and tools to their populations, usually inside value-based or preventative-care programs where a missed screening is expensive later. That aligns Healthy.io's incentives with the payer's: both win when a patient tests early.

The differentiation is harder to copy than an app. FDA clearance for the urinalysis platform (2018), the landmark Minuteful Kidney clearance (2022), CE marking, and peer-reviewed accuracy studies form a regulatory record that a fast-follower cannot shortcut. Competitors exist - Cue Health and LumiraDx in consumer diagnostics, Swift Medical and Net Health's Tissue Analytics in wound care, and the incumbent central labs like Quest and LabCorp - but few pair a home-testing consumer experience with this depth of clinical validation.

At a glance

  • Founded2013, Tel Aviv, Israel
  • HQTel Aviv, with Boston & London offices
  • CategoryDigital health · smartphone diagnostics
  • Team~110 employees
  • Revenue~$62.7M (estimate)
  • ModelB2B2C - payers & health systems

Funding

  • Total~$218M across four rounds
  • Series D$50M announced May 2023
  • LeadSchusterman Family Investments
  • BackersAleph, Corner Ventures, others
  • Valuation~$300M at Series D (approx.)
  • StageLate-stage private
Expertise & people

From national CTO to the front line of diagnostics

The founding story runs through Israeli deep-tech and public service.

Yonatan Adiri founded Healthy.io in 2013 and remains its CEO. At 26 he was appointed Israel's first national Chief Technology Officer by President Shimon Peres, steering a policy of technological diplomacy - a background that shows in the company's patience with regulators and health systems. Ron Zohar, a member of the founding team, leads product as Chief Product Officer. Fortune named Adiri to a list of ten innovators shaping the future of health.

The company's depth is in an unglamorous discipline: making a consumer camera behave like calibrated lab equipment across thousands of phone models and lighting conditions, then proving it in peer-reviewed studies. That is where the decade of "scientific breakthroughs" Zohar describes actually lives.

26
Age Adiri became Israel's CTO
4
Minuteful products & platform
ISS
Kidney test flew to space
$9M
Inui Health acquisition, 2020
Timeline

A decade in the lab and the clinic

2013

Founded in Tel Aviv

Yonatan Adiri launches Healthy.io to turn the smartphone camera into a medical-grade diagnostic device.

2018

FDA clears the urinalysis platform

The core smartphone urinalysis system is cleared as a Class II clinical diagnostic device.

2019

Minuteful for Wound launches

AI-powered digital wound management extends the company beyond urine testing.

2020

Acquires Inui Health, expands in the US

Buys the US competitor for about $9M and grows its at-home urinalysis footprint.

2022

Landmark Minuteful Kidney clearance

The first smartphone-powered home ACR test cleared by the FDA.

2023

$50M Series D and restructuring

Raises a round led by Schusterman Family Investments, then refocuses its workforce on core products.

2025

NHS wound-care pilots expand

New trusts, including Cheshire and Wirral Partnership, launch pilots of Minuteful for Wound.

FAQ

Questions people ask

What does Healthy.io do?

It turns a smartphone camera into a clinical-grade medical device, enabling at-home urine tests for kidney disease, UTIs and pregnancy, and AI-powered digital wound management for clinicians.

Is Healthy.io's kidney test FDA cleared?

Yes. In 2022 its Minuteful Kidney test received FDA 510(k) clearance - the first smartphone-powered home test cleared to measure the urine albumin-to-creatinine ratio.

Who founded Healthy.io and when?

It was founded in 2013 in Tel Aviv by Yonatan (Jonathan) Adiri, who serves as CEO. Ron Zohar is a founding team member and Chief Product Officer.

How does Healthy.io make money?

Through a B2B2C model. Health plans, providers and national health systems pay to deploy its tests and tools to their patients, rather than the company relying on direct consumer retail sales.

How much funding has Healthy.io raised?

Approximately $218M in total, including a Series D led by Schusterman Family Investments announced in 2023.

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Healthcare at the speed of life