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Withings Debuts Connected Home Urine Lab

By Deborah Borfitz 

January 4, 2023 | Since Withings founder Eric Carreel bought his company back from Nokia in 2018, the consumer electronics company has broadened its focus from nice-to-have smart health devices that support daily well-being to connected, medical-grade products whose health impacts are being scientifically validated. The latest addition to the arsenal is U-Scan, which can perform daily ​​urinalysis with a smart device that sits inside any toilet bowl, according to Julius Dewavrin, who is managing the product as well as handling regulatory requirements for its hoped-for introduction to the clinic. 

The “miniaturized health lab,” as it has been dubbed, has potential utility in the hands of everyday people—be it to gain insights on their metabolism (U-Scan Nutri Balance), monitor their menstrual cycle (U-Scan Cycle Sync), or assess the biomarkers associated with a host of medical and health conditions (U-Scan For Professionals). For the first two indications, U-Scan will become available to consumers in Europe for non-medical purposes in the second quarter of 2023. 

Medical professionals interested in biomarker analyses will have to wait on the approval of regulatory authorities, based on clinical trials around specific use cases. First up is a study being conducted in partnership with nephrologist Marie Courbebaisse, M.D., Ph.D., at the Georges Pompidou European Hospital in Paris, which is intending to show U-Scan’s ability to improve follow-up on patients with renal lithiasis and uric acid renal lithiasis—diseases caused by kidney stones—​​based on the detection of pH and specific gravity biomarkers. 

In addition to the use case for kidney stones, Withings Health Solutions entered a partnership with Franck Perez, Ph.D., research director at the French National Centre for Scientific Research and chairman of the cell biology and cancer unit of the Institut Curie in Paris, on at-home testing to detect bladder or ovarian cancer as suggested by elevated urine albumin and creatinine levels. It will be the first such approach to noninvasively monitor for cancer relapse and screening purposes, Dewavrin says. 

Biomarker Detection 

The modular technology made a splash at the International Consumer Electronics Show in early January as the world’s first hands-free connected home urine lab. The two consumer health cartridges are going up for sale on the Withings website, the one offering daily hydration and nutrition biomarker analysis (specific gravity, pH levels, vitamin C, and ketone) combined with an in-app coaching experience to help individuals optimize their dietary and water intake, and the other a means for women (via biomarkers for luteinizing hormone, pH levels, and specific gravity) to predict their menstrual cycle and determine their ovulation window as well as their protein-vegetable and water balance. 

The lifetime of a cartridge in the toilet is “up to three months,” says Dewavrin, with the ability to get more than 100 biomarker test results. The starter kit (one U-Scan and one cartridge) for consumers will sell for €499.95, after which a subscription plan becomes available offering automatic refills on the cartridges costing roughly ​​€30 per month. 

U-Scan Nutri Balance and Cycle Sync are “absolutely useful” for improving overall daily health even if they are unregulated and therefore not a reimbursable medical expense, says Dewavrin. However, payer coverage is being sought for clinical application of the device because of its potential to reduce healthcare system spending via urine-based disease prevention and management.  

Withings Health Solutions, the company’s B2B division founded in 2019, is developing U-Scan For Professionals. Solutions can be tailored to analyze a combination of markers, including those being used in the consumer cartridges and first medical use cases as well as “bespoke cartridges” that can be created for other usage scenarios, Dewavrin says. Depending on the intended purpose, the cartridges may or may not require specific regulatory approval to use outside of the research setting.  

The plan is for U-Scan to become a physician-prescribed urine test involving regular, hands-free sampling and analysis at home in lieu of the usual pee-in-the-cup procedure that happens sporadically at a third-party lab. Withings has no intention of replacing labs with their arsenal of sophisticated diagnostic equipment, notes Dewavrin, but to have U-Scan be a complement to existing solutions. 

U-Scan For Professionals is compatible with Withings remote patient monitoring solution, says Dewavrin. Partnering professionals, leveraging API, can also bring the data to their own environment and use it to offer ​actionable​ advice to their patients. 

Medicalized Bathroom 

Withings was created by Carreel in 2008 and launched a string of attractive, health-bettering devices, starting with the world’s first smart scale, says Dewavrin. The company, which competes with Apple and Fitbit in the consumer wearable space, later began connecting the devices to a cellular network so people could easily transmit data on their heart rhythm, blood pressure, and weight to their doctor's office. More recently, it began automatically syncing data via Wi-Fi to the associated Health Mate app, including measurements generated by Nutri Balance and Cycle Sync. 

In 2022, one million new Withings devices were installed, he reports. And 72% of users continue using the devices for more than three years. 

The latest move to medicalize the bathroom is part of a broader industry trend. In addition to more than a dozen other smart scales that have hit the market in recent years, Google and its subsidiary Verily Life Sciences has reportedly been filing patents for a reimagined bathroom where the mat in front of the sink provides an electrocardiogram, the mirror over the top measures skin color variations that can indicate blood volume changes, and a toilet-seat sensor provides a cardiac pressure-volume loop (gold standard measure of cardiac function). 

Withings also has a Body Scan scale that just received CE medical clearance. The connected health station is enabling a nerve health score to detect peripheral neuropathies as well as perform a 6-lead ECG—but for now, only in Europe.   

A battery-powered, cloud-connected, toilet seat–based cardiovascular monitoring system developed as a demonstration project by the Rochester Institute of Technology points to the possibility of an in-bathroom sensor for clinical-grade measurements of blood pressure, stroke volume, and blood oxygenation (JMIR mHealth and uHealth, DOI: 10.2196/12419). Engineers at Duke University have also conjured up a smart toilet to monitor gastrointestinal health, a project born their experience in global sanitation for the developing world, and subsequently launched a spin-out company (Coprata) with the goal of commercializing the device. The acoustical sounds of excretion events are additionally being explored as a means to track spikes in cases of diarrhea.  

For Withings, the final destination is not the bathroom but the home itself, says Dewavrin, referencing the company’s line of sleep enhancing and analyzing products. The company believes in a future where individuals are empowered to improve their health daily using everyday objects. 

Overcoming Challenges 

U-Scan was four years in the making and resulted in 13 application patents, Dewavrin reports. One of the chief challenges in developing the platform was to create a “flawless” experience for users who would only have to urinate normally and have results transmitted instantly to their phone. 

Access to a Wi-Fi network is required to use the U-Scan, another move to improve the user experience since people don’t necessarily have their phone with them when using the toilet, he says. After a few initial uses with the phone nearby, the device can automatically distinguish between various users thanks to a Stream ID feature that recognizes an individual’s urine stream signature. 

Then there was a long list of technical difficulties, which notably included how to ensure stable chemical reactions in the environment of the toilet, continues Dewavrin. The device was also given a pebble shape to direct urine flow on the face of the device to collection points at the back of the product where a thermal sensor detects its presence. 

A miniature pump inside U-Scan delivers the sample to a rotating cylindrical cartridge containing dozens of test pods where the biomarkers of interest are measured by an optical sensor—no external sample capture or strips required, explains Dewavrin. Within minutes, test results are transmitted via Wi-Fi to the user’s phone. The cartridge then rotates to expose the next test pod to the sample injection point. 

How to go about getting the innovation approved as a diagnostic device is the current dilemma, says Dewavrin. The regulatory environment in the U.S. is “completely different” than the one in Europe, so Withings has been engaged in discussions with authorities at the Food and Drug Administration (FDA) to explore the best way forward there. 

The FDA’s 510(k) submission process, which requires demonstration of substantial equivalence to another legally marketed device, is but one of the paths being eyed now, he continues. What the predicate biomarker detection device would be if a 510(k) submission is pursued is the question.  

This could potentially be a test strip for a single disorder, for which many would-be comparator products exist. But Withings foresees U-Scan becoming a multiplex assay for a broad range of conditions where U-Scan would be squaring off against a newer generation of rapid tests with their own panel of biomarkers, says Dewavrin.   

The pandemic has of course been impeding progress across the in vitro diagnostics (IVD) industry, at least in the U.S. where the FDA was temporarily declining IVD pre-submission requests unless they related to COVID-19, points out Dewavrin. “That’s why we started with Europe; we had a very clear path.” 

But even here there are new complexities. In May of 2022, the European Union (EU) Commission replaced its In Vitro Diagnostic Directive with the In Vitro Diagnostic Regulation (IVDR), which has designed only eight “notified bodies” responsible for transitioning the entire industry. The lead time for new product accreditations has therefore been extended, Dewavrin says.

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