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Masimo's 'MightySat' Fingertip Pulse Oximeter Now Available From Apple

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Masimo has announced that its MightySat fingertip pulse oximeter can now be purchased from Apple.com and select Apple retail locations in the U.S. and Canada.

masimo-mightysat.jpg

The pulse oximeter provides noninvasive measurements of oxygen saturation, pulse rate, and perfusion index, allegedly with greater accuracy than over a dozen other hospital-grade pulse oximeters.
In a study of 70 healthy volunteers during conditions of movement and low blood flow, Masimo SET was the most accurate pulse oximeter when compared to 19 other hospital-grade pulse oximeters. SpO2 accuracy was defined as being within 7% of the reference value and pulse rate accuracy as being within 10%.
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The measurements and trends are sent to iPhone or iPad via Bluetooth LE and stored in the Masimo Personal Health app available in the App Store, while the data can also be shared with Apple's official Health app if permission is granted.

MightySat is $299, while a premium version that also measures respiration rate and pleth variability index is available for $399.

Article Link: Masimo's 'MightySat' Fingertip Pulse Oximeter Now Available From Apple
 
Article Link
https://www.macrumors.com/2016/09/06/masimo-mightysat-now-available-from-apple/
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MacRumors said:



Masimo has announced that its MightySat fingertip pulse oximeter can now be purchased from Apple.com and select Apple retail locations in the U.S. and Canada.

masimo-mightysat.jpg

The pulse oximeter provides noninvasive measurements of oxygen saturation, pulse rate, and perfusion index, allegedly with greater accuracy than over a dozen other hospital-grade pulse oximeters.The measurements and trends are stored in the Masimo Personal Health app available in the App Store, while the data can also be shared with Apple's official Health app if the user grants permission.

Article Link: Masimo's 'MightySat' Fingertip Pulse Oximeter Now Available From Apple
Click to expand...
I'm not endorsing the product or the company, but THIS could be a very useful /meaningful application.
 
And the price is...?

I can't find it on Masimo's webpage, and I'm interested on one of this devices, a reliable one, but not too expensive.
 
Totally confused what a Perfusion Index is. And that's after looking it up.

Is it conceivable that a future Apple Watch can read (by itself) via sensors on your wrist under the watch blood pressure and body hydration levels?
 
O2 sats error limits of 7%..?!!
That's appalling, and renders this a toy if true.
 
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Mac Fly (film) said:
Is it conceivable that a future Apple Watch can read (by itself) via sensors on your wrist under the watch blood pressure and body hydration levels?
Click to expand...

Absolutely it is! This sort of thing is only a matter of time. Whether it will be decades or not is a different matter.

I've always thought that Star Trek gives us the vision and human ingenuity will eventually give us the means.
 
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Scottsoapbox said:
This is $18 on Amazon if you're willing to read the numbers on the device instead of your iPhone...
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Link? Sounds amazing. Bluetooth LE providing noninvasive measurements of oxygen saturation, pulse rate, and perfusion index for $18.
 
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This is not a first. Nonin has been shipping a fingertip mounted pulse oximeter with a BLE link and an iOS app for over a year now.

There are also several Chinese made BLE enabled Pulse Oximeters with questionable FDA certification you can find via Amazon. These are legal to buy but if they do not have FDA approval, you can get in a lot of trouble putting them in clinical use.

As the promotion said, it is all about accuracy.
 
Scottsoapbox said:
Uh you don't need bluetooth if your not using your phone.

This is the one used by my doctor's office:
https://www.amazon.com/AccuMed®-CMS-50DL-Oximeter-Carrying-Landyard/dp/B00MNRSWJE/ref=sr_1_3?ie=UTF8&qid=1473169572&sr=8-3&keywords=pulse+oximeter
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Thanks. Just the bog standard readers we have currently.

It would be nice to have things automatically logged to your phone/tablet/desktop with graphs created on the fly to spot trends, rather than taking manual readings. Especially if taking readings is a regular occurrence.

The Masimo is certainly pricey, but for those that need it could be worth it.
 
As an Amazon Associate, MacRumors earns a commission from qualifying purchases made through links in this post.
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azfalcons said:
Ha ha that price. I'm a respiratory therapist and the pulse ox I use on real patients works great and I paid 30 from Amazon
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At that price, is it cleared by the FDA? There are a lot of cheap Pulse Oximeters sold as "fitness" devices that are not cleared for clinical use.
 
CFreymarc said:
At that price, is it cleared by the FDA? There are a lot of cheap Pulse Oximeters sold as "fitness" devices that are not cleared for clinical use.
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I doubt the $30 one from Amazon is designed for clinical use, the cheapest I have ever seen one for is $80. Looking at the descriptions for the cheap ones on Amazon say they are made to FDA spec, but never say anything about a approval or certification for clinical use. Usually see in the discription sport/health enthusiast.

I'm not saying the cheap ones are not accurate, most usually are when your testing them on yourself. The big question would be how does it compare in all situations. I don't think I'd trust my patient's life, or my career to a not certified device.
 
Mac Fly (film) said:
Totally confused what a Perfusion Index is. And that's after looking it up.

Is it conceivable that a future Apple Watch can read (by itself) via sensors on your wrist under the watch blood pressure and body hydration levels?
Click to expand...

The Apple Watch already has a pulse oximeter, but it's not enabled, likely because of the huge delay/effort needed for FDA approval.

https://9to5mac.com/2015/04/24/apple-watch-blood-oxygen/

The FDA's not wrong to test and regulate vital medical devices, and Apple certainly could not delay EVERY Apple Watch generation over that one feature. But it's a shame it can't happen quicker.
 
nagromme said:
The Apple Watch already has a pulse oximeter, but it's not enabled, likely because of the huge delay/effort needed for FDA approval.

https://9to5mac.com/2015/04/24/apple-watch-blood-oxygen/

The FDA's not wrong to test and regulate vital medical devices, and Apple certainly could not delay EVERY Apple Watch generation over that one feature. But it's a shame it can't happen quicker.
Click to expand...

Top of the wrist is not a great place for gathering SpO2 data through reflectance, which I suspect Apple found out. Yes, it appears that there are some extra LEDs and sensors in there, but that alone doesn't make a pulse oximeter.

So, I wouldn't jump on the FDA. Nor is the FDA approval process all that horrible.

Source: I worked on SpO2 devices when they were first coming out, participated in FDA data collection and clinicals. There's a reason why the fingertip sensors are still dominant - they work.
 
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Why cant Apple put this feature in its watch???

BMcCoy said:
O2 sats error limits of 7%..?!!
That's appalling, and renders this a toy if true.
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You would be shocked at the error rates of these devices, even in hospitals.

My dad was in hospital a few times and the SpO2 was an estimate at best because so many factors and interfere with the reading.

This is what FDA has that I could find:http://www.fda.gov/RegulatoryInformation/Guidances/ucm341718.htm#s4
Note under Ch 1:
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.
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Here is some stats I found
http://www.ebay.com/itm/Finger-Fing...ulse-Heart-Rate-Monitor-battery-/262561134069
http://www.ebay.com/itm/CONTEC-Sale...r-SPO2-monitor-blood-oxy-CE-FDA-/111549812169

====
https://www.accessdata.fda.gov/cdrh_docs/pdf7/K073094.pdf

PS: at the asking price for device in article, NO WAY.
 
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I'd like to see Foreflight and other aviation EFB's be able to display this info on screen. For me, having this, along with blood sugar on 2-3 second intervals, with color coding would be good for pilots.

And, if you think 7% error is bad for an Oximeter, you should see the error rates for blood glucose strips...

How accurate is your blood glucose meter?

A major study found that almost half of meters do not meet the minimum required standards:

  • For blood sugars over 75 mg (4.2 mmol): Accurate within 20%. For example, if your blood sugar is 200 mg (11 mmol), the meter must read between 160 (8.8 mmol) and 240 (13.3 mmol) at least 95% of the time.
  • For blood sugars under 75 mg (4.2 mmol): Accurate within 15 mg. For example, if your blood sugar is 60 mg (3.3 mmol), the meter must read between 45 (2.5 mmol) and 75 (4.2 mmol) at least 95% of the time.
There is a new proposal that would require all results to be within 15%
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Yep... if you're at 75, you could be at 65 mg/dl or 90 mg/dl, but honestly, for me, they're pretty tight, not at the extremes. It's just the panic of the OMG! These can be off and KILL YOU!
 
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JeffyTheQuik said:
I'd like to see Foreflight and other aviation EFB's be able to display this info on screen. For me, having this, along with blood sugar on 2-3 second intervals, with color coding would be good for pilots.

And, if you think 7% error is bad for an Oximeter, you should see the error rates for blood glucose strips...



Yep... if you're at 75, you could be at 65 mg/dl or 90 mg/dl, but honestly, for me, they're pretty tight, not at the extremes. It's just the panic of the OMG! These can be off and KILL YOU!
Click to expand...

Sobering info.

More sobering is a lot of people say AW should not do Sp02 because it needs FDA approval, wont be accurate, and yet they have no idea the lack of accuracy of approved devices!

Thanks for posting.
 
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