“We believe blood pressure monitoring will change more in the next five years than it has in the past 100 years,” said Ryan Kraudel, vice president of marketing for biosensor maker Valencell, while talking about the company’s innovation in blood pressure monitoring. Zoom in/ Zoom out for CES 2022.
Such a bold statement can often be disguised as an exaggeration, but the thing is, after hearing what Valensl is working on, his prediction doesn’t seem so far-fetched at all. A calibrated cuff-free sphygmomanometer can make measuring blood pressure as simple as measuring your heart rate with a smartwatch today.
What is Valencell working on?
When you want to measure your blood pressure, you use either one of these familiar cuffs or a slightly high-tech product without a sleeve to do so. Both are clearly medical devices, although they are rarely particularly portable and certainly not easy to use as they are rather noisy and intrusive. The cuff-free versions are better, but you still need to pair them with the cuffed version regularly to make sure they’re still accurate. Valencell’s innovative new technology is completely different.
“Blood pressure devices without a cuff need to be regularly calibrated with a bracelet to ensure they are working properly, and should be regulated by the Food and Drug Administration (FDA),” Kraudel said. “The innovation in our technology requires absolutely no calibration. We need a person’s age, height, weight and gender, and this, combined with data from our sensor, allows us to get an accurate blood pressure reading.”
Using its software algorithms and a small sensor, along with the same PPG sensor found in most smartwatches and wearable fitness devices today, Valencell’s calibration-free approach will make measuring your blood pressure as seamless and simple as using the electrocardiogram (ECG) feature on a device. Today’s Apple Watch, more importantly, will have the required level of accuracy until it gets FDA approval.
“We’ve performed clinical studies under the same ISO standards for FDA-approved blood pressure cuffs, and we meet them, although we don’t need to be calibrated,” Kraudel said.
You may not have heard of Valencell, but there’s a good chance you’ve used one of their PPG sensors. It’s been in the business for 15 years, and its sensors are in 70 different devices on sale today from names like Samsung, LG, Sony, Jabra, Bose and Peloton. Kraudel explained the motivation behind the company’s quest to make blood pressure monitoring easier than ever.
Everyone knows that high blood pressure is a bad thing, but the problem is big. “One billion people have high blood pressure, and it’s a silent killer with no outward symptoms,” Crodell said. “Nobody likes using a blood pressure cuff, so people don’t measure enough, and even people diagnosed with high blood pressure rarely measure their blood pressure. The easier it is for you to monitor it, the more it helps people manage their high blood pressure, or detect it before it becomes Problem “.
How easy is that? Kraudel demonstrated Valencell’s technology using a small handheld device with a sensor just a few square millimeters in size built into it, and connected via Bluetooth to a smartphone. After touching the sensor for 30 seconds, his blood pressure appeared in the app along with his heart rate. It’s never been more complicated or time consuming than taking an ECG on your Apple Watch, which involves pressing and holding the Digital Crown for a short while.
How is this possible?
How can measure blood pressure without a cuff or calibration? Kraudel let us in on the secret:
“We don’t directly measure blood pressure,” he said. “We estimate blood pressure based on machine learning algorithms that saw sufficient data from PPG sensors combined with blood pressure readings, in order to estimate blood pressure across a variety of populations, including diversity in human physical characteristics, and blood pressure ranges. It is The same methodology is used to measure heart rate, blood oxygen, SpO2, and respiratory rate, and then our algorithm is used to measure blood flow dynamics to estimate blood pressure.”
How accurate is this estimate? Crucially, the results that Valancel sees meet the standards required by the Food and Drug Administration for all cuff-free blood pressure monitors.
“We tested it on more than 7,000 people, collected 25,000 data sets, using artificial intelligence (AI) and machine learning to estimate blood pressure. These databases didn’t exist before, so we had to create them. We performed clinical studies under the same ISO standards set for handcuffs. Blood pressure which has been cleared by the FDA, and we meet it, although we don’t need to be calibrated.”
Without being too technical, Kraudel elaborated in more detail about the level of accuracy achieved by his calibration-free and cuff-free method:
“The FDA’s ISO standard is at least 85 subjects, the mean error must be less than plus or minus 5 mmHg, and the standard deviation is less than or minus 8 mmHg. This is the level of accuracy we see in our wearable technology, when ear and fingertips.
Put it in the product
Valencell’s sensor and algorithm technology is so small that it can fit in an earpiece, in a device that fits on the tip of your finger like a pulse oxygen monitor, or even on the back of a smartphone (much like the first heart rate sensors) or the chassis of a laptop . However, a smartwatch makes the most sense, and Kraudel said it’s currently working with a smartwatch maker to fit the main sensor into the watch’s frame.
However, Valencell doesn’t just allow device makers to handle it and hope for the best; It actually decouples the industry by making its own reference product and submitting it to the Food and Drug Administration for approval. The hope is that the device, which measures blood pressure with fingertips, will help speed approval for other companies down the road and may eventually be sold by Valencell, once again to help introduce the technology to the world.
“We’re not going to make every effort to get it through the FDA without having the opportunity to recoup some of the costs,” Kraudel said. “Plan in action.”
The accessibility of technology is good news for the ultimate cost of the hardware it’s included in as well. Since it uses the same PPG sensor that many are incorporating into a new wearable anyway, the cost of integrating Valencell’s blood pressure algorithm wouldn’t make much difference to the manufacturer’s total cost at the device level. It’s the cost of putting the device through the FDA approval process, and all the work involved in that, is going to be much more significant. That’s why Valensl is hopeful that its FDA-approved reference model will pave the way and help lower costs at this point.
When will it come and what next?
We mentioned Kraudel’s claim that the way we monitor blood pressure will change a lot over the next five years. Does this mean we have to wait five years before seeing this technology? No, Kraudel made us a Valencell plan.
“By the end of this year, we expect to get clearance from the Food and Drug Administration, after which the products will follow, and we think many more unregulated devices will arrive this year,” Kraudel said. “We are working with other device makers to integrate the sensors now, but obtaining FDA approval is complex and time-consuming.
Food and Drug Administration approval can take a long time. It took Withings more than a year to get approval for a ScanWatch smartwatch, for example, so we might not see the first examples until 2023. However, the sensor-driven blood pressure monitoring technology demonstrated by Kraudel isn’t Valencell’s final game. And he revealed what she’s working on in the next few years.
“We want to be really passive about blood pressure monitoring,” Crodell said. “We are working for a system that collects data in the background, and that would [monitor blood pressure] Like a smartwatch that reads your heart rate and blood oxygen during the day now. It needs more data collection before it becomes a reality, as the wrist is a difficult place to read biometrics accurately. It has a time frame of three to four years.”
Kraudel explained why Valencell continues to move forward with innovation in unrestricted, calibration-free blood pressure monitoring when other companies aren’t headed down the same path:
“A lot of companies are working on non-pressure blood pressure monitors, including all the major smartwatch makers, and they all benefit from similar technology that requires regular instrument calibration, but is not a long-term solution for widespread consumer adoption. That’s why we’ve stayed the course, and see Calibration-free technology is the way to go.Hypertension is a huge public health problem that we think we can address in a simple way, by making blood pressure monitoring much easier than it is today to help people either keep it under control, or not go down the path in the first place. the first . “