BodiMetrics Introduces the First FDA-Cleared Pulse Ox Wearable That Works with Darker Skin Pigmentation
Traditional blood oxygen devices have a serious flaw: they aren’t as accurate for people with darker skin tones. Co-founders Neil Friedman and Mark Goettling have solved this health equity dilemma with their circul+ Smart Ring, which has a unique, patented design that takes readings from the underside of the hand.
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Everyone Knew and Nobody Did Anything
“For decades, there was a known problem, and people swept it under the carpet. Covid just laid bare the long standing issue and related deaths in darker skinned individuals.”
Neil Friedman is not a man to pull his punches, especially when it comes to healthcare inequity or injustice. Today he’s talking about what the New England Journal of Medicine called “the non-intended racial discrimination” of blood oxygen measurements using a pulse oximeter on people with darker skin tones. Pulse oximeters gauge blood oxygenation numbers by measuring the amount of oxygen in red blood cells using lights shined into the skin of the finger, so it makes sense that for over 40 years, doctors and researchers knew or should have known that fingertip pulse oximeters placed on darker pigmented skin may provide inaccurate readings.
Based on pulse oximeter readings, doctors can diagnose various pulmonary diseases and determine treatments including whether a patient needs supplemental oxygen. Inaccurate blood oxygenation readings could mean patients aren’t maintaining the oxygen levels in their system to sustain their health and may not get the oxygen they need. A Harvard Medical School study in 2022 determined that Black, Hispanic, and Asian patients in intensive care units received less supplemental oxygen than Caucasian patients because of inaccurate pulse ox readings. With blood oxygen being one of the key metrics for triaging and treating patients with Covid, it’s little wonder that people of color suffered disproportionately poor outcomes — including death — during the pandemic.
“During Covid, everyone ran to buy fingertip pulse oximeters or, here in NYC, minority populations were handed them by their doctors. The readings weren’t accurate,” says Friedman. “The healthcare community knew about the problem for years and didn’t do anything about it.”
There’s Got to Be Another Way
Friedman and his business partner Mark Goettling knew that patient monitoring, particularly when it came to blood oxygen, could be better, much better. When their company, BodiMetrics, looked to enter the remote patient monitoring (RPM) space, they took their time testing and validating the device they built to see if it could accurately monitor patient blood oxygen without a pigmentation problem. After years of experimentation and different mods, they figured out a solution that met their exacting standards and introduced CIRCUL Ring in 2019 and second-generation circul+ Smart Ring in 2021.
The key, or what Friedman calls the “secret sauce,” lies in the patented form factor of the circul+ design. Worn on the finger like a ring, the device has spring loaded expandable sides to maintain a snug fit. This stabilizes the sensor because it can expand and contract with the patient’s movements and gives it the ability to provide medically accurate and actionable metrics. This stability and the fact that the light sensors lie on the palm side of the patient’s hand solves the issue of skin color, as the inside of the finger is lighter than the outside.
“It’s a hospital on your finger, providing clinically valid data continuously every second via our patented form factor. This gives clinicians and patients alike the information needed to monitor and manage their chronic conditions and general wellbeing,” emphasizes Goettling.
The BodiMetrics circul pro ring recently received FDA 510(k) Clearance and the Mayo Clinic just released a peer-reviewed study proving that the ring provides accurate blood oxygen measurements in all tones. This is a huge boon for the company, with Friedman describing the study as an earthquake in the industry.
“Once that message is out there, every CEO of a healthcare system, an insurance company, etc. can’t hide from the fact that other measurement devices have a pigmentation problem that our device is clinically validated to solve.”
Competitive Landscape
Besides its proven effectiveness across different skin tones, the circul+ ring runs, well, circles around its competitors in terms of providing clinically relevant, actionable data. While other wearables take periodic measurements of blood oxygen levels during sleep (the Oura ring, for instance, measures every 15 minutes), only the circul+ provides measurements every second, making it the most accurate on the market. As sleep expert Meir Kryger from the Yale School of Medicine put it, “this is the only consumer device measuring and storing oxygen level heartbeat by heartbeat.”
And sleep is a big deal when it comes to overall health. Just last year the American Heart Association added sleep to their checklist of essential components for optimal cardiovascular health. Poor quality of sleep contributes to problems with blood pressure and increases the risk of heart disease, stroke, and diabetes. The circul+ ring quantifies its users sleep quality using multiple key performance indicators, like heart rate variability, temperature, oxygen desaturation, and sleep stages.
BodiMetrics has a multi-year head start on their competitors in terms of crossing over from the fitness-focused wearables market to the medical world. They have three-year partnerships with both Kaiser Permanente and the United States Department of Veterans Affairs (VA). In addition, they just signed an agreement with Carahsoft, a huge player in government and public sector and holder of government contracts. As a health solution, their target market is the chronically ill, those who are aging in place, rural communities, and anyone who is medically or geographically underserved.
“Our device accurately measures more data than any other, and our mobile and cloud-based applications use AI and machine learning to contextualize that data for both the clinician and the patient to manage exercise, stress, sleep, and other important factors for health.”
Onward and Upward
Besides their partnerships with providers like Kaiser and the VA, BodiMetrics sells products to consumers through wholesalers and retailers like Walmart and McKesson and directly to consumers via ecommerce from their own website, Amazon, and Sharper Image, and they have more retailers lined up. Although their eye is on the healthcare market, their product also appeals to the health conscious consumer who wants to accurately track their sleep and fitness metrics, a market that is expected to reach $612B by 2024.
What the two founders love hearing the most, however, are the stories of real patients who received better care because of accurate readings. Just the other day, Friedman received a phone call from a physician in an ICU unit about a Black patient from whom they couldn’t get a good blood oxygen read. Then they used the circul+ ring, and it got the reading perfectly.
Our Take
Thanks to the tireless work of managing co-founders Neil Friedman and Mark Goettling, BodiMetrics’ real-time monitoring solution, circul+ Smart Ring and app, is extremely well-positioned in both the healthcare and consumer wearables market. As Friedman put it, “we are a great team.” Together they combine backgrounds as serial entrepreneurs in technology, healthcare, manufacturing, and distribution. The duo are backed by some of the most distinguished doctors in the sleep and pulmonary space as business advisors. We can’t wait to see how far they can go in the journey to provide next-level health metrics to patients and consumers.
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Published: Nov 2, 2023