Those of us who are interested in wearable technology have been sitting tight for quite some time in anticipation of the next great thing in this space. It is reasonable to state that it has been quite some time since we were exposed to something that could be considered truly novel.
There has been discussion regarding the analysis of sweat, the tracking of blood pressure from the wrist, and non-invasive glucose monitoring. A prototype of the first of these, known as the Gatorade Gx Sweat Patch, has already been made available to the public. During physical activity, the slap-on monitor can identify several fundamental statistics, such as the degree to which the user has been dehydrated. However, this is just the beginning of the process.
In addition to this, non-invasive monitoring of glucose levels is now being developed. However, there has been nothing in the way of an actual product that can be used in the real world.
Monitoring blood pressure at the wrist, on the other hand, appears to offer the most potential at the moment. Aktiia, based in Switzerland, is the first company out of the gate with a system that can monitor blood pressure round-the-clock and has been scientifically verified.
When it comes to major brands, their main opponent at the time is Samsung. They have only just added support for monitoring blood pressure on the Galaxy Watch 3 and Watch Active 2 devices. This, too, operates through the use of an optical heart rate sensor, just like the Aktiia device does.
The distinction is that the accuracy certifications for Samsung’s measurements are different from those held by other brands. In addition to this, their solution is not automatic but rather works on demand. Consider the example of measuring the amount of oxygen in the blood. Devices that track this on-demand are vastly different from those that automatically take readings while you are sleeping. This is something that is readily apparent to anyone who has ever had a wrist wearable that contained a SpO2 sensor. The second is quite helpful, especially in this situation.
In the interest of full disclosure, I should talk about the Omron Heartguide. It has been available for a few years now, and it operates from the user’s wrist. However, this sphygmanometer is the size of a watch and comes equipped with a small inflated cuff. Therefore, we cannot consider them to be the same.
Interview with Aktiia’s Chief Executive Officer, Michael Kisch
Michael Kisch, the CEO of Aktiia, and I had a conversation about their product as well as broader developments in the health and fitness industry. After putting their bracelet through certain tests over the past few weeks, I can say that it performs rather admirably. After a few days, I will post my comprehensive assessment here.
The readings of your blood pressure are taken at various times during the day and night while you are at rest. According to the findings that I obtained, up to ten measurements can be done in a single day. There is no need to press any buttons because everything will be completed for you behind the scenes.
The fact that these readings are accurate to the level specified by ISO standard 81060-2 is what makes this achievement truly remarkable. The wearable medical device is classified as a Class IIa device with a CE certification. This indicates that the measurements are taken with clinical precision (in the form of a cuff).
This is not a suitable alternative to a smartwatch or a fitness band
Resting heart rate is the sole additional parameter that can be measured with the Aktiia wristband. Because of this, it is essential to keep in mind that it is not to be confused with a “conventional” fitness band or a smartwatch.
The present version of Aktiia’s product is not designed to take the place of a fitness band or smartwatch. Our ideal customer is someone who is concerned about their cardiovascular health, either because they are at risk for developing a condition such as hypertension or because they have already been diagnosed with the ailment.
Because this user population has a higher chance of having a heart attack or a stroke, they demand a product that offers a higher resolution of data and deeper insights than what is currently available. In addition, because they are frequently under the care of a physician, it is necessary for them to find a solution that their physician would support and rely upon as the foundation for making judgments regarding diagnosis and treatment.
The Aktiia bracelet has a very understated appearance, which is appropriate given that it is not intended to serve in place of a smartwatch or a fitness band. Due to the discrete nature of its design, it can be worn on the same wrist as another device without interfering with its functionality.
The significance of keeping track of one’s blood pressure
It’s possible that you’re curious about the significance of monitoring your blood pressure. It’s possible that some of you are familiar with the term “silent killer,” which is another name for high blood pressure. This is because a lot of people don’t realize there’s a problem until it’s too late to do something about it.
The prevalence of hypertension continues to rise. It is the major cause of heart attacks and strokes, which together account for 18 million deaths per year, making it the most prevalent chronic ailment in the world, affecting 1.4 billion people. Our ability to combat hypertension has been significantly hampered due to a lack of data.Traditional blood pressure cuffs frequently result in inaccurate diagnosis, clinical inertia, and a lack of tailored input for the user because they are only used once or twice a week at most.
But even if you do test your blood pressure from time to time, it can be challenging to keep track of the fact that you should do so on a consistent basis. My dad had to deal with the effects of high blood pressure. Because of the medication, he had to take his measures on a very consistent daily basis. However, his condition deteriorated each time he went to see a physician for treatment. His blood pressure would suddenly increase, which would result in abnormally high readings. This is what’s known as the “whitecoat syndrome,” which literally translates as “more tension in a clinical atmosphere” in English.
Because Aktiia’s monitoring is automated, collecting data around the clock, over the course of days, weeks, and months, and providing a much more detailed perspective of a person’s blood pressure trend is exceedingly simple and straightforward.
This could offer the user a more in-depth insight into how their dietary choices, level of physical activity, and amount of sleep affect their cardiovascular health. Additionally, it can increase the accuracy of diagnosis by explicitly reducing the effect of whitecoat hypertension and masked hypertension, which are both known to alter blood pressure readings. Lastly, it can unearth particular characteristics that have been proved to enhance a person’s risk of a heart attack or a stroke. These characteristics can be found in a person’s family history. By gaining an awareness of these unique characteristics, a new treatment strategy may be implemented, which will result in a reduction in the risk for each individual.
Where exactly is the other competition?
In the not-too-distant future, it is reasonable to assume that Aktiia will not face any significant challenges from its immediate competitors. There is no doubt that there is an abundance of connected blood pressure monitors that simplify the process of getting readings. However, this is only true in the sense that all of the information is saved to a mobile app. In many other respects, many of these devices are not that unlike the conventional versions of the same thing. At the end of the day, what they are are cuffs that can be inflated.
A standard inflatable cuff is utilized by ninety-nine percent of today’s commercially available blood pressure measuring equipment. In the year 2020, 57 million of these products were sold all over the world. The primary objective of Aktiia’s current competitive strategy is to entice users away from competing goods by providing a more refined user experience and more in-depth insights at a price point comparable to those of the competing solutions.
It is possible that this will shift at some point in the future. On the other hand, Mr. Kisch anticipates that these will be manual blood pressure checks as opposed to automatic solutions.
We estimate that within the next two to three years, the majority of consumer wearable devices will be able to provide spot-check measurements of blood pressure. This will result in a significant increase in the number of individuals who will monitor their own blood pressure. We anticipate making sales of our existing offering, which will include our own hardware, to a segment of this population that is searching for improved precision and a more in-depth understanding of how their cardiovascular health affects their lives.
In the near future, random blood pressure checks will become the norm
Valencell made the announcement at CES 2021, which took place earlier this year, that its sensors will soon be able to monitor blood pressure. In a manner analogous to that of the Aktiia bracelet, the Valencell accessory collects data from an accelerometer in addition to the green blinking lights of a PPG sensor that shine into the wearer’s wrist.
At some point in the future—most likely not this year, but possibly in the latter half of 2022—blood pressure readings will become a standard component of the activity tracking data on wearables that are extensively utilized. However, as these kinds of measurements become more widespread, it is likely that they will not have the same certificates of accuracy as Aktiia does. In the fast-paced world of wearable technology, companies simply won’t have the time to clear all of the regulatory hoops that are necessary for a wearable to be considered a medical device.
There is a significant amount of interest among consumer wearable device manufacturers in the incorporation of spot-check measurement of blood pressure into their products. Within the next two to three years, I believe that the majority of these firms will have some capability to spot-check measure blood pressure and that each of these companies will gain the fundamental regulatory clearance required to legally market a blood pressure monitoring device.
This will unquestionably be a step forward from the previous experience of having an expanding cuff, but it won’t make much of a difference in terms of how individuals who have problems with their cardiovascular health are recognized and treated. It is necessary to be able to capture the full blood pressure pattern in order to make a significant impact. In addition to this, a genuine dedication to clinical validation, the cultivation of connections with key opinion leaders, and engagement with medical professionals, health systems, and insurance providers is essential.
In the end, wearable companies want to incorporate health features into their products, but they are not healthcare companies, and it is not their stated goal to advance the standard of care for the diagnosis and treatment of people who have cardiovascular health issues. However, these companies do want to integrate health features into their products.
The Aktiia bracelet may now be purchased in the UK, with availability in additional nations expected to follow soon
Withings’s Scanwatch has shown that the United States Food and Drug Administration (FDA) is a more difficult regulatory hurdle to overcome than those in Europe. It is currently possible to purchase the Aktiia bracelet in the United Kingdom. You may find more information about it at Aktiia.com. It is anticipated that other European nations will follow suit. The United States of America ought to follow suit soon.
We have staff members located in Switzerland, the United Kingdom, Serbia, and the United States. Because English is the language most commonly used within the organization, it made sense for us to develop the mobile app, website, and hardware packaging in English. Additionally, it made sense for us to concentrate on the United Kingdom as our primary first launch market. We are in the last phases of translating the app, website, and packaging into German, French, and Italian.We want to travel through Germany, Austria, France, and Switzerland beginning on May 4th. We are now in discussion with the FDA and are making progress in gaining access to the market in the United States.
Developments in both the software and the hardware
In both the realms of hardware and software, Aktiia has ambitious goals in mind. In addition to the work that is taking place right now in terms of translating documents, there are also certain software improvements that are coming up. Even though we are still in the beginning stages, there will eventually be a version 2 of the bracelet released as well.
In the future, we have many exciting plans for the software, including the addition of new insights such as day versus night analysis, the capability to “label” the data so that the user and their physician can better understand the specific impact that diet, exercise, medication, and stress have on the user’s cardiovascular health, and the addition of targeted heart health tips based upon each user’s unique blood pressure pattern.
In terms of the product’s hardware, we want to make ongoing enhancements to the product’s design, battery life, and initialization procedure in the hopes of achieving our goal of creating a seamless integration between the product and the user’s life.
The possibility of contracting out the maintenance of this equipment prompts an immediate question. one of the major brands like Garmin, Apple, Polar, Samsung, or Fitbit, perhaps. After all, the vast majority of wearables on the market today include PPG sensor technology, which is used to obtain heart rate readings.
It would appear that Aktiia does not have any such ambitions. On the other hand, there is the possibility of integration.
Since we are in the business of health algorithms and data, there are no current plans to contract out the creation of algorithms to a large wearable manufacturer. Nevertheless, both our algorithms and cloud services are hardware agnostic, and we have the intention of eventually making the Aktiia 24/7 service accessible via the devices manufactured by other businesses.
Keeping an eye on the years to come
The technology developed by Aktiia is pioneering new territory. Who would have thought that blood pressure readings could be taken from the wrist with the same level of accuracy as a cuff just a few short years ago?
There are sensors in our phones, watches, homes, and vehicles, and more are on the wayIn the not too distant future, there will be an even greater abundance of sensors. In the next three to five years, we will see a distinct evolution of consumer wearables. These wearables will transition from devices that generate data related to health and wellness to clinically validated medical devices that are able to provide consumers as well as healthcare providers with information that is truly relevant. In order to arrive at that destination, there will need to be persistent advancements made to the sensor quality, algorithm accuracy, and continual validation.
According to our assessment, consumer wearables are in a prime position to screen huge populations of users for a range of health issues and then support those users in moving on to the next stage of their health journey. It will soon be possible to use sensors in ways that are even more compelling as a result of advancements in technology that will reduce power consumption, shrink the size of sensors, and speed up communication. In addition, we see enormous potential in the data that is presently being acquired to draw even more value from it than is now being extracted. What are the several factors that might either have a favorable or negative effect on our blood pressure and blood glucose levels? What effects do a person’s diet, level of physical activity, level of stress, and amount of sleep have on their cardiovascular and metabolic health?
When it comes to the development of sensor technology, it is abundantly obvious that exciting days lie ahead!