How taking your blood pressure is about to be as easy as taking your heart rate

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“We think blood pressure monitoring will change more in the next five years than it does in the past one hundred years,” said Ryan Crowdell, vice president of marketing at biometric sensor manufacturer Valancel. On Zoom for CES 2022 talking about the company’s innovation in blood pressure monitoring.

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Such a bold statement can often be seen as an exaggeration, but the point is, after hearing what Valencel is working on, her prediction doesn’t seem far-fetched at all. its cuff-free, calibration-free blood pressure monitor Measuring your blood pressure can make it as simple as measuring your heart rate with a smartwatch today.

What is Valancel working on?

When you want to measure blood pressure, you use one of those familiar cuffs or a slightly higher-tech cuff-free product to do so. Both are clearly medical devices, however, they are rarely particularly portable and certainly not suited to use as they are noisy and somewhat intrusive. The cuff-free versions are better, but still need to be regularly paired with the cuffed version to ensure they remain accurate. Wellencell’s innovative new technology is very different.

Ryan Crowdell, VP Marketing, Valencel
Ryan Crowdell, VP Marketing, Valencel

“Cuff-less blood pressure devices require regular calibration using cuffs to ensure they are working correctly, and have to be regulated by the Food and Drug Authority (FDA),” Crowdell said. . “The innovation with our technology is that there is never a need for any calibration. We need a person’s age, height, weight and gender, and this, together with the data from our sensors, gives us an accurate blood pressure reading. allows for. “

Using its software algorithm and a tiny sensor, along with the same PPG sensor found on most smartwatches and fitness wearables today, Valancel’s calibration-free approach makes measuring your blood pressure as intuitive and simple as using the electrocardiogram (ECG) feature. Will give Apple Watch today, and just as importantly, it will have the level of accuracy needed to gain approval from the FDA.

A Withings Connect Blood Pressure Monitoring Cuff
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“We have conducted clinical studies according to the same ISO standards for FDA-cleared blood pressure cuffs, and we meet them, even though we do not require calibration,” Crowdell said.

industrial experience

You may not have heard of Valancel, but there’s a good chance you’ve used one of its PPG sensors. It’s been in business for 15 years, and its sensors are found in 70 different devices on sale today under names including Samsung, LG, Sony, Jabra, Bose, and Peloton. Crowdell explained the motivation behind the company’s quest to make blood pressure monitoring easier than ever.

“Everyone knows high blood pressure is bad, but the problem is huge. One billion people have high blood pressure, a silent killer with no outward symptoms,” Crowdell said. “No one likes to use a blood pressure cuff, so people aren’t measuring enough, and even people with diagnosed hypertension rarely measure their blood pressure. The easier it is to measure your blood pressure.” The more we monitor, the more it will help people manage high blood pressure, or catch it before it becomes a problem.”

ECG on Apple Watch Series 7.
Taking ECG on Apple Watch Andy Boxel/Nerdshala

how easy? Crowdell demonstrated Valencell’s technology using a small, handheld device embedded with sensors just a few millimeters square in size, which connected to a smartphone via Bluetooth. After touching the sensor for 30 seconds, his blood pressure appeared in the app along with his heart rate. It was no more complicated or time-consuming than taking an ECG on an Apple Watch, which involves briefly pressing and holding the Digital Crown.

How can this be?

How is it possible to take blood pressure without cuffs or calibration? Crowdale lets us in on the mystery:

“We are not measuring blood pressure directly,” he said. “We are estimating blood pressure based on machine learning algorithms that have looked at blood pressure readings as well as enough data from PPG sensors to determine the diversity of human physiological characteristics and blood pressure ranges across a whole diverse population, including blood pressure. It is the same method used to measure heart rate, SpO2 blood oxygen and respiration rate, then it uses our algorithm to measure blood flow dynamics to estimate blood pressure .

How accurate is this assessment? Importantly, Valencel is looking to meet the standards required by the FDA for all of its cuff-free blood pressure monitors.

“We have tested this on over 7000 human subjects, collecting 25,000 data sets using artificial intelligence (AI) and machine learning to estimate blood pressure. These databases did not exist before, so we had to create them. Have performed clinical studies according to the same ISO standards set for blood pressure cuffs that have been approved by the FDA, and we meet them, even though we do not require calibration.

Without getting too technical, Crowdle went into more detail about the level of accuracy that its cuff-free, calibration-free method is achieving:

“The ISO standard for the FDA is for a minimum of 85 subjects, the mean error must be less than plus or minus 5 mmHg, and the standard deviation must be less than plus or minus 8 mmHg. This is the level of accuracy we consider for wearable devices. Looking over the ears and fingers in his technique.”

put it in a product

Valencell’s sensor and algorithmic technology is small enough that it can be fitted in an earbud, in a device that fits at your fingertips like a pulse oxygen monitor, or even on the back of a smartphone (long before the heart like a motion sensor) or a laptop chassis. However, it’s smartwatches that make the most sense, and Crowdell said it’s currently working with a smartwatch maker to fit the main sensor into a watch’s bezel.

Samsung Galaxy S5 review rear light
Samsung Galaxy S5 with Rear Heart Rate Monitor

However, Valencel not only let device makers go ahead with it and hope for the best; It’s actually separating itself from the industry by creating a reference product of its own and submitting it to the FDA for approval. The hope is that the device, which measures blood pressure on the fingertips, will help expedite approval for other companies down the road and may eventually be sold by Valencell, again to help introduce the technology to the world.

“We’re not going to put in all that effort to get it through the FDA without the opportunity to offset some of the costs,” Crowdell said. “A plan in the works.”

Access to technology is also good news for the final cost of equipment. Since it uses the same PPG sensors integrated into many new wearables anyway, the cost of integrating Valencell’s blood pressure algorithms won’t make that much of a difference to a manufacturer’s overall cost at the device level. It’s the cost of putting the device through the FDA’s approval process, and all the work involved, that will be far more significant. That’s why Valencell hopes that its FDA-approved reference model will smooth the road at this stage and help cut costs.

When is it coming, and what’s next?

We cited Crowdell’s claim that the way we monitor blood pressure will change significantly in the coming five years. Does this mean that we will have to wait five years before we see this technology? No, Crowdale drew up Valencel’s plan for us.

“We expect to have FDA approval by the end of this year, and products will follow after that, and we think there will be a lot of non-regulated devices coming out this year,” Crowdell said. “We are now working with other device manufacturers to integrate the sensor, but it is complex and time-consuming to obtain FDA approval.”

FDA approval can actually take time. For example, it took Withings more than a year to get approval for the ScanWatch smartwatch, so it may not be until 2023 that we see the first examples. However, Crowdell demonstrated that sensor-powered blood pressure monitoring technology isn’t the final game for Valencell, and he revealed what it’s working on for a few years to come.

“We want to be really passive in terms of blood pressure monitoring,” Crowdell said. “We are working towards a system that collects data in the background, which [monitor blood pressure] Like a smartwatch now reads your heart rate and blood oxygen during the day. This needs more data collection before it becomes a reality, as the wrist is such a challenging place to read biometrics accurately. It has a time frame of three to four years.”

Crowdell explained why Valencell continues to lead with innovation on cuff-free, calibration-free blood pressure monitoring, when other companies are not following the same path:

“Several companies are working on cuff-less blood pressure monitoring, including all major smartwatch makers, and all take advantage of similar technology that requires regular calibration with cuffs, but that is gaining ground for mass consumer adoption. This is why we have stayed the course, and see calibration-free technology as the way forward. High blood pressure is a huge public health problem that we think we can do with blood pressure. Making surveillance a lot easier than it is today can address it in a small way so that people can either keep it under control, or prevent it in the first place.”

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