Those of us that follow wearable tech have been waiting for the next big thing for a while now. It’s fair to say it has been a few years since we’ve seen something truly new.
There’s been talk of sweat analysis, blood pressure tracking from the wrist, non-invasive glucose monitoring. We’ve seen glimpses of the first of these in the guise of the Gatorade Gx Sweat Patch. The slap on device can detect some basic stats such as the level of de-hydration during exercise. It is, however, only a first step.
Non-invasive glucose monitoring is also in the works. But so far there’s been nothing in terms of an actual real-world product.
It is, however, blood pressure monitoring from the wrist which currently holds the most promise. And the first out of the starting block with a clinically validated, 24/7 blood pressure tracking solution is Swiss-based Aktiia.
Essential reading: Best fitness trackers and health gadgets
Their only competitor at the moment when it comes to big brands is Samsung. They’ve recently enabled blood pressure tracking on Galaxy Watch 3 and Watch Active 2. Just like the Aktiia device, this works via an optical heart rate sensor.
The difference is that Samsung measurements don’t hold the same certifications for accuracy. Also, their solution is on-demand rather than automatic. Take the example of blood oxygen measurements. Anyone who owns a wrist wearable with an SpO2 sensor knows there’s a big difference between devices that track this on-demand and those that automatically take measurements while you are asleep. The second is many times more useful.
For completeness sake, I should mention the Omron Heartguide. It has been around for a couple of years now and also works from the wrist. However, this is a watch-sized sphygmanometer with a miniature inflatable cuff. So not really the same thing.
Q&A with Micheal Kisch – Aktiia CEO
I spoke with Aktiia CEO, Micheal Kisch to discuss their device and the wider trends in the health and fitness space. I’ve been testing their bracelet for a number of weeks now and found that it works well. My full review will follow in a few days time.
The blood pressure readings are captured during the day and night while you are at rest. I found that on average up to 10 measurements are taken during 24 hours. No buttons to push, everything is done for you automatically in the background.
What’s makes this particularly impressive is that these readings meet the ISO81060-2 standard for accuracy. The wearable has the CE marking as a Class IIa medical device. Which means the measurements are taken with clinical (cuff-like) accuracy.
Not a replacement for a smartwatch or fitness band
The only other metric the Aktiia bracelet measures is resting heart rate. So it’s important not to confuse it with a “traditional” fitness band or smartwatch.
“Aktiia’s current product is not intended to replace a fitness band or smartwatch. Our target user is someone who takes their cardiovascular health seriously because they are either at risk for or have already been diagnosed with a condition like hypertension,” Mr Kisch says.
“Given this user populations increased risk for heart attack and stroke they require a product that provides a higher resolution of data and deeper insights. In addition, because they are often under the care of a physician, they require a solution that their physician will endorse and rely upon as the basis for diagnostic and treatment decisions.”
While it is clearly not meant as a replacement for a smartwatch or fitness band, the Aktiia bracelet is very low key. Its discreet design means you can wear it along with another device on your other wrist.
The importance of blood pressure tracking
You might be wondering why blood pressure tracking is important. Some of you might know that high blood pressure is sometimes called the “silent killer”. That’s because many people don’t spot there is something wrong until it is too late.
“Hypertension is an epidemic. It’s the #1 global chronic condition afflicting 1.4 billion people and is the leading cause of heart attacks and strokes which account for 18M deaths annually. Our ability to fight hypertension has been significantly limited by a lack of data. Traditional blood pressure cuffs are only used 1-2 times per week often leading to incorrect diagnosis, clinical inertia and a lack of targeted feedback to the user,” Aktiia CEO says.
But even if you do take blood pressure measurements from time to time, it is difficult to remember to take them regularly. My father suffered from high blood pressure. He had to take measurements pretty much every day because of medication. But his situation was made worse when he would go and visit a doctor. His blood pressure would spike making the readings unusually high. This is the so called whitecoat syndrom – in English this means raised stress in a clinical setting.
“Aktiia’s automated monitoring makes it incredibly easy to capture 24/7 data over days, weeks and months providing a much higher resolution view of the person’s blood pressure pattern,” Mr Kisch adds.
“This can provide the user a more thorough understanding of the impact of diet, exercise, and sleep on their cardiovascular health. It can also improve the accuracy of diagnosis specifically by eliminating the distorting effect of whitecoat and masked hypertension. Finally, it can uncover specific traits that have been shown to increase a person’s risk for a heart attack or stroke. By understanding these individual traits, a different treatment approach can be taken that will lower each person’s risk.”
Where’s the competition?
It is fair to say, Aktiia should have no worries in the near future when it comes to direct competition. Sure there are a plethora of connected blood pressure monitors which make taking readings easier. But this is in the sense that all the data is saved to a smartphone app. In other aspects many of these devices are not much different from their traditional counterparts. At the end of the day they are inflatable cuffs.
“99% of the devices sold today to measure blood pressure use an inflating cuff. In 2020, 57M of these products were sold worldwide. Aktiia’s current competitive focus is to shift users away from these products by offering a more elegant user experience and deeper insights for a similar price point.”
This is likely to change further down the line. But Mr Kisch expects these to be on-demand blood pressure checks rather than automatic solutions.
“In the next 2-3 years we anticipate that most consumer wearable devices will be able to spot-check measure blood pressure. This will greatly expand the population of people who will monitor their blood pressure. We anticipate selling our current product including our own hardware to a subset of this population who are looking for greater accuracy and deeper insights into their cardiovascular health.
Spot blood pressure checks will soon become the norm
At CES 2021 earlier this year Valencell announced its sensors will soon be able to track blood pressure. Similar to the Aktiia bracelet, Valencell utilizes the green blinking lights of a PPG sensor that shine into your wrist, along with info from an accelerometer.
Eventually, probably not this year, perhaps in the latter part of 2022 blood pressure measurements will become part of the staple of activity tracking data on widely used wearables. But when such measurements hit the mainstream – they will probably not have the same certificates of accuracy as Aktiia. In the quick-moving world of wearable-tech, brands simply won’t have the time to jump all the regulatory hurdles required for a wearable to be classified as a medical device.
“There is intense interest among consumer wearable companies to integrate spot-check measurement of blood pressure into their devices. In the next 2-3 years I think that most of these companies will have some ability to spot-check measure blood pressure and that each company will secure the basic regulatory clearance required to legally market a blood pressure monitoring device.”
“This will definitely be an improvement over the experience of an inflating cuff but will do little to advance the way that people with cardiovascular health issues are diagnosed and treated. To make a real impact requires the ability to capture the full blood pressure pattern. It also requires a real commitment to clinical validation, building relationships with key opinion leaders and engaging with physicians, health systems and insurers.”
“At the end of the day, wearable companies want to integrate health features into their products, but they are not healthcare companies and it’s not their stated goal to advance the standard of care for the diagnosis and treatment of people that have cardiovascular health issues.”
The Aktiia bracelet is currently available in the UK with other countries to follow soon
As Withings has found with their Scanwatch, the US FDA is a tougher nut to crack than European regulators. The Aktiia bracelet is currently available to buy in the UK. You can check it out at aktiia.com. Other European countries are expected to be next. The US should also follow soon.
“We have employees based in the US, UK, Serbia and Switzerland. English is the common language for the company, so it was logical for us to develop the mobile app, website and hardware packaging in English and to focus on the UK as our initial launch market. On May 4th we plan to enter Germany, Austria, France and Switzerland and are in the final stages of translating the app, website and packaging into German, French, and Italian.” Mr Kisch says.
“We are engaged with the FDA and working towards US market access in the near future.”
Software and hardware improvements
Aktiia has big plans in terms of hardware and software. In addition to the translation activity that is going on at the moment, there are also some software updates in store. Although it is still early days, version 2 of the bracelet will also come at some stage.
“Moving forward we have exciting plans for the software including new insights like day vs. night analysis, the ability to “label” the data so that the user and their physician better understand the specific impact of diet, exercise, medication and stress on their cardiovascular health and targeted heart health tips based upon each user’s unique blood pressure pattern.”
“For the hardware, we anticipate making continued improvements to the design, battery life and the initialization process in an effort to make the product blend in seamlessly with the user’s life.”
A question that springs to mind is to do with the potential to outsource this technology. Perhaps to one of the big brands such as Garmin, Apple, Polar, Samsung or Fitbit. After all, most wearables these days have PPG sensor technology that is used to capture heart rate measurements.
It seems Aktiia has no such plans. But there could be some sort of integration.
“We are a health algorithm and data company so there are no plans to outsource algorithm development to a large wearable company. However, our algorithms and cloud services are hardware agnostic and we do plan to make the Aktiia 24/7 service available via other companies’ devices over time.”
Looking to the future
Aktiia is treading new ground with its technology. Blood pressure measurements from the wrist with cuff-like accuracy – who would have imagined it only a few years ago.
“Sensors are everywhere, in our phone, in our watch, in our house, in our car… and more will come in the future. In the next 3-5 years we see a clear evolution of consumer wearables, evolving from devices that generate health and wellness data to clinically validated medical devices that can provide consumers and healthcare providers with information that really matters. To get there requires continued improvement in sensor quality, algorithm accuracy and ongoing validation.”
“We see consumer wearables being ideally positioned to screen large populations of users for a variety of health conditions and then assisting those users in taking the next step in their health journey. Improvements in power consumption, reduction in sensor size, and faster communication technologies will make it possible to use sensors in even more compelling ways. In addition, we also see significant potential to derive more value from the data that is already being gathered. What are the variables that positively and negatively impact our blood pressure and blood glucose? What is the impact of diet, exercise, stress and sleep on each individuals cardiovascular and metabolic health?
Exciting times are clearly ahead when it comes to sensor technology!
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