Valencell Blood Pressure Monitor | Introducing the World's First Cuffless Blood Pressure Monitor in a Finger Clip (Features, Availability, and FDA Decision)

Valencell presented what it says is the world's first cuffless blood pressure monitor - the Valencell Blood Pressure Monitor. The device doesn't appear to be like anything else on the market. Valencell announced plans for the product in 2021 and revealed the final product at CES 2023 this Tuesday.   

Valencell -- the company behind sensors in your Samsung, Suunto, Bose, and Jarba products -- is well-known in digital health. President and co-founder Steven LeBoeuf has patented more than 100 wearable biomedical sensors, with expertise in photoplethysmography (PPG) sensors.  

For over a decade, Valencell has been collecting raw data with PPG technology with the hope of bringing products with accurate results to market and helping consumers manage chronic conditions.

In this article, we aim to explore all there is to know about the Valencell blood pressure monitor. Scroll on.

About Valencell

Valencell was founded in 2006 by R&D leaders from the tech industry, and Valencell’s 150+ patented inventions have been foundational for accurate biometric monitoring during exercise and everyday life activities. Empowering people to live longer, healthier lives is the main focus of their innovative inventions.

Valencell is an acclaimed innovator in digital health solutions with a focus on chronic disease management. They develop and deliver medical-grade digital health solutions that are intuitive, accurate, and easy to incorporate into everyday health routines. 

Valencell’s patented biometric sensor technology, proprietary algorithms, and analytics, used by third-party wearable solutions on the market today, have been clinically validated by thousands of diverse participants over many years.

Best known for their award-winning motion-tolerant heart rate monitoring inventions, now proliferated in tens of millions of wearable devices, they have built upon this foundational technology to address unmet needs in the prevention and management of chronic diseases, such as hypertension, respiratory disease, and diabetes.

Their inventions, technology, and sensor modules have been utilized by dozens of brands across the world, including Samsung, Suunto, Bose, Jabra, Huawei, Sony, and more.

Recent innovations have propelled Valencell from the sports/fitness marketplace into the consumer medical sector, where they have now built upon their legacy technology to enable their own branded solutions, targeting over-the-counter use.

Valencell’s investors include Best Buy, Halma, GII Fund, TDF, Sonion, and WSJ Joshua Fund. The company has also been supported by millions in government grants from the National Institutes of Health (NIH), the National Science Foundation (NSF), and the North Carolina Board of Science, Technology & Innovation. Clinical collaborators have included the Duke Center for Living, North Carolina Research Campus, Campbell University, and numerous industry leaders in medical solutions and pharma.

The Valencell Blood Pressure Monitor

Upon analyzing its own PPG datasets, Valencell developed an algorithm that can measure blood pressure patterns. From there, it designed a device that can read blood pressure without calibration or a cuff. It simply goes over your finger.

The device is small and black, has a built-in screen that shows diastolic and systolic results and connects to an app on your phone via Bluetooth. It "fits a little snug but no squeeze. It is similar to a fingertip pulse oximeter," LeBoeuf told CNET. Once over the finger, the product reads blood pressure in under a minute.  

When connected to the device, the app will keep a record of all past readings and can graph trends over time. Consumers will be able to download and share their data and set daily or weekly reminders to check their blood pressure.  

Valencell plans soon to expand the app to include hypertension management. It will then be able to coach users and suggest diet and exercise plans.  

The device is still pending FDA approval but Valencell is expecting clearance soon. Once approved, the product will be available over the counter. It is expected to retail for about $99.

You can watch the demo of the Valencell Blood Pressure Monitor below by the Valencell team:

So, How Does the Valencell Fingertip Blood Pressure Monitor Work?

Valencell has collected thousands of datasets from around the world and transformed years of data into better digital health solutions.

Powered by advanced analytics built upon tens of thousands of raw datasets collected from thousands of human subjects, Valencell has been breathing life into wearable photoplethysmography (PPG) sensors for over 15 years.

Photoplethysmography (PPG) sensors within the device use reflected light to measure blood flow patterns. Proprietary AI algorithms will process this information in combination with the user’s physical characteristics (age, weight, biological sex, height) to calculate a blood pressure measurement. Diastolic and systolic results are then displayed on the device’s built-in screen and transmitted via Bluetooth to the app.

If you’ve seen the green blinking lights on the back of a smartwatch or fitness band, that’s probably utilizing at least one of Valencell’s inventions. Those lights are shining light into the body, and the sensor is capturing blood flow patterns within the scattered light. 

The challenge is that these patterns cannot be extracted in a simple, linear fashion. To address this limitation, Valencell has developed a “Deep-PPG” neural network that is capable of analyzing these patterns to determine biometrics such as blood pressure, heart rate, heart rate variability, blood oxygenation, respiration rate, and more.

What Does the Valencell Fingertip Blood Pressure Monitor Have to Offer? - Features of the Valencell Blood Pressure Monitor

1. Powered by Innovation

• This innovative Fingertip™ Blood Pressure Monitor device and mobile app will simplify how people measure and manage hypertension.
• Take control of your health with blood pressure measurements made easy.
• Paired with an easy-to-use mobile app that tracks and stores readings.

2. Effortless and Stress-Free

• Easy-to-use Fingertip™ Blood Pressure Monitor device and app.
• No more bulky or painful cuff.
• Backed by our patented biometric sensor technology.

3. Easy-to-use and Quick Measurement

• One-minute measurement.
• Numbers are easily visible on the device and the mobile app.
• The mobile app is not required to get a measurement.
• One-button operation.
• Lightweight and portable for use at home or on-the-go.

4. Track Your Numbers

The new Valencell Fingertip™ Blood Pressure Monitor device and mobile App will simplify blood pressure management by doing or allowing efficient access to the following:
A. Monitor History + Trends

• Our intuitive mobile app tracks and stores readings.
• View trends over time and track the frequency of your measurements.

1. Confidently Take Care

• Set reminders so you never forget to take your blood pressure.
• Capture and share data with your loved ones or healthcare providers.

Have the Valencell Blood Pressure Monitor Being Cleared by the FDA?

The Valencell Fingertip Blood Pressure Monitor was supposed to obtain FDA clearance sometime in late 2023, but due to reasons unknown to us yet, the Fingertip Blood Pressure Monitor hasn’t gotten FDA clearance. Therefore, the Valencell Blood Pressure Monitor is not for sale anywhere, especially in the US.

However, according to the Valencell team, the Valencell Fingertip Blood Pressure Monitor is set to get FDA clearance this year. So it’s just a matter of some time before the Valencell blood Pressure Monitor becomes available OTC.

How Much is the Valencell Fingertip Blood Pressure Monitor and Where Can You Get It?

The Valencell Blood Pressure Monitor isn’t available for sale as it is still pending FDA approval, but for the price of the product, Valencell said it’ll sell the product for $99.

Future of Digital Health Devices

Valencell's cuffless, calibration-free personal blood pressure monitor, once FDA-approved, would be available not just for personal use, but also for professional use by doctors.

Demand exists for personal, medical-grade devices -- over-the-counter hearing aids, for instance, hit the market late last year -- and as more products follow and get into the hands of everyday consumers, that will mean more accessible health care.  

Valencell plans to expand in the future, possibly putting this technology into everyday objects such as smartphones or watches to make measuring vitals even easier.