Many new health tech devices employ new or unconventional sensor technologies to track biometrics. Validating a new measurement device against the current gold standard for the given metric is health tech grail. We’ve written about a range of blood pressure reading technology that tries to get close to the reliability of the standard upper arm inflatable cuff measurements. Companies are developing devices that use optical sensors, pressure sensors, and single lead ECG electrodes either separately or in combination. Valencell’s optical sensor and MSU’s combination of optical and pressure sensors on a smartphone case have both drawn our attention. Everyone agrees upper arm cuff tests are awkward. Even the smaller wrist-worn pressure cuffs are best for at home use and are not optimal for people who need continuous blood pressure monitoring.
This year at CES 2018 Omron Healthcare gave attendees an early look at HeartGuide, the company’s smartwatch built around an oscillometric (inflating) blood pressure monitor. Omron is quite likely the brand name on the electronic cuff-style blood pressure measurement devices your doctor uses. Omron is also a major vendor in consumer electronic blood pressure devices, with various upper arm and wrist cuff devices. So now Omron is coming out with its own wearable using the gold standard technology, only smaller. HeartGuide will come in small, medium, and large sizes for accuracy, fit, and comfort, but it will still be bulkier than other smartwatches. That’s because the watch will self-inflate. According to the company, Omron has filed more than 50 technology patents including blood pressure component miniaturization in designing the first wearable oscillometric wrist blood pressure monitor. The watch also will measure daily activity, heart rate, and sleep quality, and will be able to be set to read blood pressure while the user is sleeping (so long as they are wearing the watch). According to Omron, the watch band uses a flexible synthetic material that is five times stronger than steel; this allows it to inflate without losing its shape. HeartGuide will also sync with Omron’s Connect app to store, track, and share data with healthcare professionals.
No tech before its time. Omron said at CES HeartGuide will not be available on the retail market until its accuracy is clinically validated and FDA cleared, which it expects to achieve near the end of 2018. The price will be announced at launch.
I would hope that the company could give a substantive update on the status of the smartwatch as theyhave been seeking FDA clearance since January 2016 or perhaps before (as announced at CES 2016).
Yes, I hope this isn’t vapor wear. I’ve been keeping an eye out since 2016 and am disappointed with how little information is out there and the fact that I’m not wearing one now.
I think the ViCardio device has more of a chance at getting to market sooner, and its not a cuff! worthwhile checking it out. http://www.vicardio.com
Richard, thanks for bringing that to our attention. I like that it relies on mechanical measurement (motion) rather than just light. I’m not clear yet on why it doesn’t need calibration, however. I need to look into this further. I also wish the website had more information about when they expect it to ship, but I can understand that they may want to be conservative in their projections.
All the best,
Alfred Poor, Editor
Hi: For calibration and/or accuracy is it ok to compare the readings on a wrist watch blood pressure monitor with a more accurate (?) reader in a doctor’s office and then add or deduct numbers as appropriate ?
Calibration is tricky. If a given device has a wide margin of error, then you won’t be able to come up with an easy correction. If the device is relatively accurate — the numbers are wrong but they are consistently wrong — then you may be able to work out some compensation. Think of a weight scale that always reads 10 pounds too low. Just add 10 pounds to get the correct result. If it reads 10% low, then it will be 10 pounds low at 100 pounds, but 20 pounds low at 200 pounds. It’s still consistent, but you need a more complicated compensation formula. If the scale reads between 5 pounds too low and five pounds too high for any measurement, it will be difficult to compensate.
It doesn’t hurt to compare your home device with the one used by your doctor, but keep in mind that you may need to take several readings with both before you can get a good idea of its accuracy.
All the best,
Alfred Poor, Editor
An update on watch status with FDA would be helpful, let’s hope an announcement will come shortly.
It is nearing the end of 2018. I don’t see any update… Very interested in a watch.
I have been waiting for this watch for two years….. what is going on. A person could have died by now.
Sadly, this is a common story in technology. Someone announces a great product, and in many cases, it is never heard from again. That’s why we try to be clear whether a given product is actually shipping, scheduled to ship, or just a technology demonstration. A pressure cuff incorporated into a watchband is not a trivial problem to solve, but I expect that someone will have a successful product out based on this technology before they will be able to use light and optics in a wristband to accurately measure blood pressure.
Alfred Poor, Editor
I wouldn’t mind testing one for them
My uncle has been waiting for it too, but he purchased a similar one from an online store and could be even better! He only waited for the duration that shipping took.
Tarik, I deleted the link from your comment because it is not at all the equivalent of the watch in the article. The one you recommend does not measure blood pressure.
Alfred Poor
Editor
How do I get on a beta-team for this watch?
I don’t know anything about beta testing for this device. All I can suggest is that you contact the company directly.
All the best,
Alfred Poor, Editor
I tried to apply as a beta user by contacting the company directly ~6 months ago, but was mildly rebuffed with a reply that the focus groups had already been populated by the people incharge and that interested parties should essentially be more patient. Yeah, I get that, but Omron is pumping the gas on this project and a status report from Project Zero should be in order for those they cajoled into signing up for news on it. As I said (above) they have been pushing this since before January of 2016, and its imminent release has been touted at CES 2016, 2017, and 2018.
A status report is really not asking too much at this point.
It would seem reasonable to expect a progress report, but I am not surprised. If they don’t have good news about the project, they are not likely to want to spread it around. And they may be a long way from beta testing for a bunch of reasons, ranging from good to not-so-good. Maybe there are manufacturing problems, or maybe they have funding difficulties. I expect that you’ll hear from them when they have good news (and when they’re ready to take your money.)
Alfred Poor, Editor
Estoy ínteresado en este reloj y me gustaría poder comprarlo lo antes posible o hacer algunas pruebas con el, ya que necesito tener un control de mi presión sanguínea.
Atentamente un saludo Juan
You will have to contact the company directly for more information about its availability.
Alfred Poor
Editor
FDA approval can take 3-7 years for medical devices. Although a company would like to give a date, it is up to the FDA and all the hoops the company must jump through to prove the product safe and reliable. Which is, of course, for your benefit.
I like in the UK. I would like to think that FDA approval is not required to launch the product in Europe. Why does Omron not target any other country to launch the product?
The European Union has it’s own CE certification process for health and medical products. There are efforts to bring the CE and FDA requirements more in alignment, with the hope of making the process easier for both manufacturers and consumers.
In any case, I doubt that FDA approval is the only obstacle for the Omron product.
All the best,
Alfred Poor
Editor
Hola Alfred, cuándo sale a la venta en México?
I have heard that the company is finally bringing this product to market in 2019. I will be at CES 2019 in Las Vegas in January, where I hope to find out more.
Alfred Poor
Editor
Hello.
I am also still waiting for a way to get the watch in Mexico. When should we have a definitive answer on this?
Fabio, I don’t know. You will have to contact the company directly for that information.
All the best,
Alfred Poor
Editor, Health Tech Insider
499$, only USA
https://www.prnewswire.com/news-releases/heartguide-the-highly-anticipated-first-wearable-blood-pressure-monitor-from-omron-available-for-pre-order-on-december-20th-300769335.html
https://omronhealthcare.com/products/heartguide-wearable-blood-pressure-monitor-bp8000m/