Prediction: This is what makes Apple Watch a game-changer!

[Thai]

Link: https://youtu.be/JR9kTOcwLfY

This is ECG on your wrist. AliveCor makes FDA-certified accessories. You can get phone cases that do the same thing.

Homepage of AliveCor: AliveCor-Home

(Disclaimer: i has zero association with AliveCor...only heard about it back in October.)

My father has paroxysmal atrial fibrillation (irregular heart beat). Something like this is a GAME-CHANGER in my opinion. The ability to take a one lead ECG quickly (and able to annotate) is beyond awesome, esp something that you can record and show your doctor. Have chest pain or breathing issue? Start the watch app and your ECG is there to see and review later by your doctor.

The future of Apple Watch is not going to be the watch itself IMO (100% guess)...it will be the accessory bands that has features and sensors built in...that then interacts with the Watch.

Imagine the future where you watch can read your sugar (via sweat analysis) or your body temperature. And yeah, it also sends Twitter updates too.

EDIT: the future: http://appleinsider.com/articles/16...-port-supports-battery-pack-gps-receiver-more

EDIT #2: go to Page 4.

 

[USNA91]

I'd love to see the validations they did on those...

 

[Thai]

I'd love to see the validations they did on those...

Validations? You mean testings? Well, IF it gets FDA approval (as is the case with their phone cases), then it is a medical-grade device...and thus pretty accurate/precise.

 

[Thai]

Interesting study and future uses: https://m.reddit.com/r/AppleWatch/comments/484j0k/do_you_have_an_apple_watch_and_an_alivecor_study/

 

[Thai]

Almost official!! My next watch band: Your next Apple Watch band could warn you of a stroke

 

[Thai]

Video and info on website: AliveCor

 

[BlackWorksInc]

I thought some of the newer "Smart Watches" already had this built-in and some BlueTooth enabled wristbands that worked with phones already did this?

 

[Thai]

I thought some of the newer "Smart Watches" already had this built-in and some BlueTooth enabled wristbands that worked with phones already did this?

Heart rate (pulse) is one thing...a full one lead ECG (heart rhythm) is another. This AliveCor band provides the latter. It gives the electrical activity of your heart...so, it is one BIG step above just checking your pulse.

Heart rate (pulse) number alone does not tell you if your heart is beating irregularly. Heart rate number won't tell you if you are having extra heart beats (may feel it as palpitations)...or if your heart stops beating for a few seconds (may feel it as lightheadedness, weakness).

This is a HUGE step IMO for patients that have heart issues. And this thing is (pending) FDA approved, which means that it provides medical grade data.

 

[Yukon4Runner]

I'd love to see the validations they did on those...

You certainly have reason to be concerned.

The device received 510k approval rather than Pre-market Approval (PMA) from the FDA.

What's the difference?

You are developing a new medical device do-dad. For 510k approval, you convince the FDA that this new device is pretty much the same as a previous device for which you already have approval. The evidence you submit is not to prove the device works, it's to prove it is "like" the previously approved device.

Why is this of concern?

Even professionals make mistakes; a problem with your new medical do-dad is much much much more likely to surface if it is subjected to the far more stringent tests needed for PMA where you need to prove the device provides the medical benefit you are claiming.

Why do companies chose to pursue the 510k approval rather than PMA?

Because it is a fraction of the cost...on the order of 20-50 times cheaper.

If you are concerned about a life threatening event from your heart, spend the extra money and purchase an already available medical heart monitoring device that has been subjected to the higher PMA testing standards.

If you can't afford the more expensive monitoring devices, or if you are healthy and monitoring your heart for exercise goals or simply want it for the "look what I have factor!" then this device is probably fine.

 

[Thai]

You certainly have reason to be concerned.

The device received 510k approval rather than Pre-market Approval (PMA) from the FDA.

What's the difference?

You are developing a new medical device do-dad. For 510k approval, you convince the FDA that this new device is pretty much the same as a previous device for which you already have approval. The evidence you submit is not to prove the device works, it's to prove it is "like" the previously approved device.

Why is this of concern?

Even professionals make mistakes; a problem with your new medical do-dad is much much much more likely to surface if it is subjected to the far more stringent tests needed for PMA where you need to prove the device provides the medical benefit you are claiming.

Why do companies chose to pursue the 510k approval rather than PMA?

Because it is a fraction of the cost...on the order of 20-50 times cheaper.

If you are concerned about a life threatening event from your heart, spend the extra money and purchase an already available medical heart monitoring device that have been subjected to the higher PMA testing standards.

If you are healthy and monitoring your heart for exercise goals or simply for the "look what I have factor!" then this device is fine.

Their "other" device (smartphone case with pads) is FDA approved. This watch band works by the same concept...two contact points. Data is being transmitted the same way too. So, this explains why 510k approval. Why would they (AliveCor) go thru the whole PMA route? The 510k route will fail IF FDA determines that the two devices work differently.

So, if this watch band gets 510k, then it is legit.

Medical heart monitoring device? Like a Holter? The whole point to these (AliveCOR) devices is that it is convenient to the patient to use anytime...and with watch or phone, it is always with you. And with watch band, you can annotate how you're feeling at time of check.

Does it give you a 12-lead ECG? No. But a one lead rhythm is very helpful in someone who is having symptoms.

It is like a camera analogy. I am sure that a Canon 5D takes better pictures than a smartphone camera...but a smartphone is always with you and easy to carry. What is the saying? The best camera is the one you have with you. Does this device (watch band or case) definitively diagnose your heart condition? No. But it adds (huge) amount of data leading you to visit your doctor and get it check out. Huge amount of data because it can be perform anytime and anywhere.

 

[Yukon4Runner]

Their "other" device (smartphone case with pads) is FDA approved. This watch band works by the same concept...two contact points. Data is being transmitted the same way too. So, this explains why 510k approval. Why would they (AliveCor) go thru the whole PMA route? The 510k route will fail IF FDA determines that the two devices work differently.

So, if this watch band gets 510k, then it is legit.

Lol, OK Thai.

For someone who has previously declared they have "no association" with this device you certainly are passionate about it!

Good luck with your social media marketing campaign!

 

[Thai]

Lol, OK Thai.

For someone who has previously declared they have "no association" with this device you certainly are passionate about it!

Good luck with your social media marketing campaign!

LOL...you think that i have any connection to AliveCor? Sure, keep thinking that. I am more ethical than that...don't worry. I practice what i preach.

What do you know about these medical devices? You seem knowledgeable. Are you in medical field?

If you are in the medical field, then you miss the point of these devices.

 

[Thai]

If you are concerned about a life threatening event from your heart, spend the extra money and purchase an already available medical heart monitoring device that has been subjected to the higher PMA testing standards.

Show me these devices that you're talking about.

 

[USNA91]

Im not aware of the phone-cover-with-pads device that is suggested as the predicate device above, but on its face it doesn't seem to be anything like a wristwatch.

As such, it strikes me as odd hat the Apple Watch was covered under a 510(k) if the device mentioned above was the predicate.

I'd also be curious as to what med device class it falls into (I'm too darn lazy to look it up). Class II would be my guess...

 

[Thai]

Im not aware of the phone-cover-with-pads device that is suggested as the predicate device above, but on its face it doesn't seem to be anything like a wristwatch.

As such, it strikes me as odd hat the Apple Watch was covered under a 510(k) if the device mentioned above was the predicate.

I'd also be curious as to what med device class it falls into (I'm too darn lazy to look it up). Class II would be my guess...

It is not watch vs. phone. It is the phone CASE and watch BAND. The receiving end (iPhone and Apple Watch) is where the difference is. Neither iPhone nor Apple Watch are FDA approved for anything. They are just the hub where information is sent to.

The phone CASE is FDA approved already. The watch BAND is waiting for 510k. Both case and band operate the same way (i believe). So, AliveCor is not pushing for approval of the watch and band...just the band and how it records the rhythm (which again, is same as the phone case). The BAND is just a miniature version of the CASE...from the looks of things.

 

[Thai]

FYI to anyone interested: 510(k) Clearances

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.

More here: The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance

 

[Thai]

Best picture of band so far:

 

[Yukon4Runner]

LOL...you think that i have any connection to AliveCor? Sure, keep thinking that. I am more ethical than that...don't worry. I practice what i preach.

I'm glad that you have no association with this device.

Individuals and companies engaging in the off label promotion of a medical device face serious regulatory, civil and criminal consequences.

Why, if such a person were engaged in such behavior and a complaint with the FDA were filed, then I'd expect a series of properly executed subpoenas (say for example, from discussion forum, to ISP, to IP address, to physical address) would reveal the individual and/or company engaged in such egregious activities.

Again, it's good to hear you're just an independent individual who has a particular passion for this device.

 

[Thai]

I'm glad that you have no association with this device.

Individuals and companies engaging in the off label promotion of a medical device face serious regulatory, civil and criminal consequences.

Why, if such a person were engaged in such behavior and a complaint with the FDA were filed, then I'd expect a series of properly executed subpoenas (say for example, from discussion forum, to ISP, to IP address, to physical address) would reveal the individual and/or company engaged in such egregious activities.

Again, it's good to hear you're just an independent individual who has a particular passion for this device.

LOL...you're a freaking idiot. Feel free to submit subpoenas regarding this thread!!!! LOL

Even IF I was an employee of AliveCor, how is this off-label promotion? What have I said is "off-label"??? You want to subpoena the whole damn internet because they are talking about this AliveCor band at this very moment!!!

You don't know me...so, stop with this dude. You're making an ass of yourself. Trust me. Some people on here know me well.

(Hint: the reason I am interested in this is because my father has the heart condition that this device can help him with.

Hint#2: I am in the medical field and I see great potential for a device of this caliber.)

Now that such foolishness is out of the way, can you show me these heart monitors that you mentioned earlier???? Where can I get a medical grade heart monitor for cheap without doctor's orders?

You seem so confident earlier. I honestly want to know so that I can explore other options.

But, you did get one thing right...I do love my Apple Watch and always want to find things to expand its scope of usefulness for me.

BTW, just FYI, I have made threads about specific products in the past, such as Toyota Prius and Mercedes G-wagen. Want to turn me in as Toyota and Mercedes employee too??

 

[Thai]

Here is another option: InfoBionic Receives FDA 510(k) Clearance for MoMe® Kardia -- LOWELL, Mass., March 16, 2016 /PRNewswire/ --

Website: InfoBionic's MoMe® Kardia System: Transforming the Efficiency of Arrhythmia Detection and Monitoring Management

But this is not as elegant for the consumer because the device is something that you have to wear. Targeted more for your doctors. It does more than AliveCor though with the different modes.

AliveCor is more convenient IF you own an Apple Watch.