New in-ear wearable tracks blood flow to the head

[Sushi]

Quote

“STAT Health on Tuesday announced its new in-ear wearable, the STAT, which measures blood flow to the head. When users stand up, the earpiece automatically tracks changes in their heart rate, blood pressure trend and blood flow, which are useful insights for patients who commonly experience dizziness and fainting spells as a result of illnesses like long Covid and postural orthostatic tachycardia syndrome (POTS), among others.”

Sounds interesting though it looks like it will require a subscription. They say it will give advanced warning of fainting. 

[Sarah Tee]

Wow, for me that would be amazing to be able to measure blood flow to the head. I was about to start chasing a hospital here in Australia that has transcranial Doppler via my doctor to hpget this measured, but maybe I can do it myself.

I don’t faint, but for those that do this would be very good. I know some people have trouble responding to and articulating what’s going on when they are about to faint, so if this gadget could sound an alarm to alert the wearer, or anyone nearby, I imagine that that would be very useful. A bit like what service dogs do.

[Sarah Tee]

Looks like it has been tried out at Johns Hopkins:

https://www.jacc.org/doi/abs/10.1016/j.jacep.2023.02.002

“We tested the STAT device at Johns Hopkins during Tilt Table Testing, and STAT was able to pick up blood flow abnormalities much earlier than clinical ECG and a Blood Pressure Cuff were able to. It detected blood flow drops 2-12 minutes before they actually passed out.“

Hari Tandri, MD

[Sarah Tee]

@Sushi, did you see any indication of the cost?

 

Edit:

Quote

When will STAT be available for purchase, and how much will STAT cost?

STAT will begin taking pre-orders in Fall 2023, at which time pricing will be finalized. We will be a fraction of the cost of Continuous Glucose Monitors. We are currently targeting a $50/month subscription that we aim to decrease for long-time subscribers, but pricing is still subject to change as we get a better understanding of the costs.

I suppose subscription means US only?

[MikeO]

hmm...is this just a next gen CGM?

[Sushi]

2 hours ago, Sarah Tee said:

, did you see any indication of the cost?

I don’t think it has been set yet, but they were thinking about $50 per month—which is a lot!

[MikeO]

I just reserved one. I do see this as helpful.

[Sushi]

Dr. Blitshteyn is following this on Twitter: 

https://twitter.com/fudimmarat/status/1668631897747103749?s=12

There is a lot iPod interesting information there.

[Sarah Tee]

I wish there was also a medical device version that could be leant out to people like a Holter monitor. (Although it would have been in someone else’s ear so … !)

[MikeO]

11 hours ago, Sarah Tee said:

I wish there was also a medical device version that could be leant out to people like a Holter monitor. (Although it would have been in someone else’s ear so … !)

sure if this would be lent out it would be treated like a disposable medical device. I did pay the dollar to get a VIP spot to get one. won't break the bank. if this works as advertised it will be a game changer IMO or at least for me. I would get on the early list. you won't be obligated to buy.   

[MTRJ75]

I saw this on DI's FB page yesterday, but haven't had the chance to look into it yet. A $50 per month subscription would be unfortunate and price a lot of the people it would help out. 

[Sarah Tee]

I agree, the cost will be a problem for many. Unlike typical “wellness products”, it is really only for sick people, and sick people are likely to be disadvantaged in their earning capacity.

[Sarah Tee]

Another thing to note: It doesn’t actually read blood pressure.

Quote

STAT’s BP Trend algorithm does not output mmHg, but instead provides a 0-20 Trend score to help understand your intraday BP variability. It is not intended for diagnostic use and intentionally cannot be compared against diagnostic criteria such as the 130/80 mmHg hypertension threshold.

 

[Sarah Tee]

After some digging, I found that the technology used is photoplethysmography.

[MikeO]

On 6/13/2023 at 6:49 PM, Sushi said:

I don’t think it has been set yet, but they were thinking about $50 per month—which is a lot!

Pricing chatter already came up on their facebook page. $50 per month is expensive for sure especially if the cost model comes with a contract and not a month to month service.

For now i need to see more about the product so will continue to follow it. I would pay the cost if the device actually meets my needs which would be a audible alert that my blood flow is trending low (about to pass out) and proves whooshing is real haha. CGM's have the alerts and are very useful in helping you correct a low or high. 

[Sarah Tee]

@MikeO, I look forward to hearing how it goes. If they become available in Australia, or we are allowed to purchase from overseas, I will definitely consider getting one. Although I would hate to buy/subscribe and then find it showed my cerebral blood flow was normal … I highly suspect it isn’t, but not having had it tested, you never know.

I did get a lead on transcranial Doppler testing at my old specialist’s hospital. It’s not being done for autonomic purposes (or at least the website doesn’t mention it), but it says they will investigate cerebral blood flow disturbances, so I am hopeful.

[MikeO]

@Sarah TeeI will post back. A couple of folks already asked if this is available in Australia but got no response yet. I will keep an eye for you.

crossing my fingers that you can get a transcranial Doppler test done. sure it would be telling.

[MTRJ75]

7 hours ago, Sarah Tee said:

After some digging, I found that the technology used is photoplethysmography.

What's the reliability of this tech? If it's anything like a FitBit, it's not worth much. Never used to accurately capture my heartrate. 

[Sarah Tee]

@MTRJ75, I think the method of photoplethysmography is sound, but the company hasn’t chosen to register the device as a medical device and I can see no mention of a validation process on the website. So there’s no way of knowing how reliable this gadget is, unless the company decides to do studies on it later.

If I have read rightly, photoplethysmography is what is used in fingertip pulse oximeters, and there are medically certified versions of those used in hospitals. 

As I said above, I wish the company had made a medical version as well, because that could be used for diagnostic purposes, and a “wellness device” cannot. It’s a missed opportunity because doctors could order it for a week like a Holter monitor. Oh well.

(I’m not an expert and have never used a wearable so other folks may correct me. I don’t even own a smart phone because I am horribly clumsy and would drop it and smash it for sure. My trusty Omron cuff meter has been dropped on the floor several times with no ill effects!)

[MikeO]

32 minutes ago, Sarah Tee said:

I think the method of photoplethysmography is sound, but the company hasn’t chosen to register the device as a medical device and I can see no mention of a validation process on the website. So there’s no way of knowing how reliable this gadget is, unless the company decides to do studies on it later.

validation process is in progress. Johns Hopkins did their testing and was shown to be predictive and Duke university is testing against a transcranial doppler (TCD) ultrasound tilt test and beat to beat bp. 

Again quite some chatter on facebook all i can say is i get access to the engineers as a beta tester. 

[Sarah Tee]

@MikeO, that’s good.

[MikeO]

Well beta testing is not slated till 1st qtr of next year with a larger test going into 2nd qtr. kinda telling that the product won't be out on the market for a while yet.

[Sushi]

22 hours ago, Sarah Tee said:

I wish the company had made a medical version as well, because that could be used for diagnostic purposes, and a “wellness device” cannot. It’s a missed opportunity because doctors could order it for a week like a Holter monitor. Oh well.

Kardia has done that, though it is for the patient market. It is an FDA cleared single lead EKG that is about the size of a credit card (works with a smart phone or tablet) and I carry mine in my purse. Doctors rely on it for reliable EKG reports from their patients. After my recent cardiac ablation I was asked to send a Kardia EKG strip by email each week to the nurse practitioner who was following me. Each reading is recorded on the phone APP and you can either send them to a doctor or let your doctor scroll through them. These went in my medical record. So, if this device proves reliable they could also apply for FDA clearance. 

[Sarah Tee]

@Sushi, that is a great invention for patient monitoring and good to know that companies do this.

I am afraid I am chafing at the lack of testing and options in Australia. And I’m tired of chasing everything myself and having to do the work my specialist and GP should be doing, or at least helping me with, on my own.

Such is the life of the dysautonomia patient!

[MikeO]

here i am out. devise does not meet my expectations. I already know what affects me fluid and meal wise.

Technically, STAT doesn't measure absolute Blood Pressure, but instead measures a correlate to Blood Pressure that we're calling "Blood Pressure Trend." Here's some words from the website about our Blood Pressure Trend metric: "STAT’s BP Trend algorithm does not output mmHg, but instead provides a 0-20 Trend score to help understand your intraday BP variability. It is not intended for diagnostic use and intentionally cannot be compared against diagnostic criteria such as the 130/80 mmHg hypertension threshold."

STAT's BPT algorithm is not so focused on being diagnostically useful for the ways BP is currently used in medicine, but is more intended to try to help people understand the wild intraday swings that people with Dysautonomia often experience. e.g. my BPT is lower in the afternoon after a carb heavy meal.