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[News] FDA Clears Itamar’s WatchPAT Unified
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Information FDA Clears Itamar’s WatchPAT Unified
FDA Clears Itamar’s WatchPAT Unified

Itamar Medical’s upgraded model of the WatchPAT, a sleep apnea diagnostic device, has been cleared by the FDA. This clearance was announced at the SLEEP show.

Within the upgraded WatchPAT Unified, a patented PAT (peripheral arterial tone) sensor will measure blood oxygen saturation in addition to the PAT signal in a single Unified probe. In previous models of the WatchPAT, the patient wore a watch-like device on the wrist with two finger sensors attached to it, one measuring the PAT signal and one oximetry sensor measuring blood oxygen saturation. The newest model, which features a single unified finger probe, simplifies the test procedure and improves reliability and user comfort while taking the test.

Gilad Glick, CEO of Itamar Medical, says in a release: “This is a substantial achievement for Itamar Medical. We expect our channels to the market, both through our direct sales force to the core sleep physicians and through our exclusive relationships in the cardiology space, to benefit from this FDA-cleared innovation. Itamar Medical continues to invest great efforts into its R&D with our goal to continuously lead the home sleep test market for diagnosing sleep apnea and sleep-related breathing disorders, while keeping it simple and comfortable for the patient.”

Itamar Medical is a public medical technology company developing noninvasive medical devices using its proprietary PAT signal. Its two product lines are WatchPAT, a medical-grade home device for diagnosis of sleep breathing disorders, and EndoPAT, a noninvasive endothelial function assessment device used to improve risk-stratification and to personalize treatment in symptomatic and cardiovascular disease patients across all disease states.

The PAT signal is measured noninvasively through the fingertips using a custom programmed finger sensor and signal processing algorithms developed by the company.


Fair use applies, from:
http://www.sleepreviewmag.com/2014/06/fd...t-unified/

The above post may contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. The material available is intended to advance the understanding of Sleep Apnea treatment and to advance the educational level of Sleep Apnea patients with regard to their health. Sometimes included is the full text of articles and documents rather than a simple link because outside links frequently "go bad" or change over time. This constitutes a "fair use" of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material in this post is distributed without fee or payment of any kind for research and educational purposes. If you wish to use copyrighted material from this post for purposes of your own that go beyond "fair use", you must obtain permission from the copyright owner.
07-02-2014 10:19 PM
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archangle Offline
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Post: #2
RE: FDA Clears Itamar’s WatchPAT Unified
The term "FDA Cleared" confuses me. I've seen this on lots of devices I consider to be very suspect.

Does it mean "the FDA doesn't think it will kill you?" I don't think it means the device has been shown to be "effective."

Googling this left me still somewhat uncertain about the meaning.

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07-02-2014 11:45 PM
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Post: #3
RE: FDA Clears Itamar’s WatchPAT Unified
(07-02-2014 11:45 PM)archangle Wrote:  The term "FDA Cleared" confuses me. I've seen this on lots of devices I consider to be very suspect.

Does it mean "the FDA doesn't think it will kill you?" I don't think it means the device has been shown to be "effective."

Of course, since it's a press article written by a reporter, it could mean anything... but most likely it means that the product has received 510(k) clearance, as defined here:

http://www.fda.gov/medicaldevices/produc...efault.htm

Probably similar to the 510k clearance Itamar received for a previous generation of device called the "Watch Pat 100", here:

http://www.accessdata.fda.gov/cdrh_docs/pdf/k010739.pdf

From what I've read, the 501k clearance means the FDA considers the device to be equivalent in safety and efficacy to other similar devices that have been approved by the FDA previously.

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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.

07-03-2014 10:48 AM
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archangle Offline
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Post: #4
RE: FDA Clears Itamar’s WatchPAT Unified
(07-03-2014 10:48 AM)SuperSleeper Wrote:  Of course, since it's a press article written by a reporter, it could mean anything... but most likely it means that the product has received 510(k) clearance, as defined here:

http://www.fda.gov/medicaldevices/produc...efault.htm

Probably similar to the 510k clearance Itamar received for a previous generation of device called the "Watch Pat 100", here:

http://www.accessdata.fda.gov/cdrh_docs/pdf/k010739.pdf

From what I've read, the 501k clearance means the FDA considers the device to be equivalent in safety and efficacy to other similar devices that have been approved by the FDA previously.

I read that stuff before, but I still see little to indicate it's been showed to be "effective." The "FDA cleared" seems to be a much lower standard than the FDA approval process for medicine, for instance. If anything, it reminds me of the regulation for dietary supplements like hooha root. They try to make sure it won't kill you, but don't evaluate whether it really does anything that useful.

Given some of the crap devices I've seen listed as "FDA cleared," I'm very skeptical about the term "FDA cleared."

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07-03-2014 01:30 PM
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SuperSleeper Offline

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Post: #5
RE: FDA Clears Itamar’s WatchPAT Unified
Yeah I hear 'ya on the "FDA cleared" stuff. Probably doesn't mean a heck of lot as far as finding out the true effectiveness of a particular product.

FDA doesn't use the term "effectiveness" in clearing these products, but rather the terms "safety" and "efficacy"

efficacy is defined as: the ability to produce a desired or intended result.

efficiency is defined as: performing or functioning in the best possible manner with the least waste of time and effort

So technically, (for instance) if your goal was to remove a huge rock or boulder from somewhere, you could force millions of gallons of water to flow over that huge rock that would wear the boulder down over the course of hundreds of years, eventually removing it (dissolving it I guess)... or you could just hire a guy with a jackhammer and pulverize it into oblivion in one day. Both methods have efficacy, but only one is efficient.

So, I'd say the FDA chooses it wording carefully here by using the term "efficacy".

Eat-popcorn

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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.

07-03-2014 02:07 PM
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penuel Offline

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Post: #6
RE: FDA Clears Itamar’s WatchPAT Unified
(07-02-2014 11:45 PM)archangle Wrote:  The term "FDA Cleared" confuses me. I've seen this on lots of devices I consider to be very suspect.

Does it mean "the FDA doesn't think it will kill you?" I don't think it means the device has been shown to be "effective."

Googling this left me still somewhat uncertain about the meaning.

ArcAngel, has the FDA ever approved any device to be effective? Would you regard the Itamar WatchPat to be a suspect?
06-26-2016 05:43 PM
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penuel Offline

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Post: #7
RE: FDA Clears Itamar’s WatchPAT Unified
ArcAngel, has the FDA ever approved any device to be effective? Do you think that Itamar's WatchPat is a suspect?
06-26-2016 05:47 PM
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