Exergen Temporal Artery Thermometers are not NCITs

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FDA Studies Prove Non-Contact Infrared Thermometers (NCITs) Are Not Reliable For Detecting Fevers.1,2

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Non-Contact Infrared Thermometers (NCITs) have errors due to skin emissivity, skin ambient temperatures, variable perfusion on face, perspiration on face, adding up to an error range of up to 4 deg C (7 deg F), that cannot be eliminated.4 NCITs have NO peer-reviewed published clinical studies supporting their accuracy.

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Exergen TemporalScanner Thermometers Are Not NCITs, and Are Proven Accurate in Detecting Fevers by More Than 100 Peer-Reviewed Published Clinical Studies.3

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Exergen TemporalScanner Thermometers lightly scan the forehead from the center to the hairline, which will always cross the temporal artery. The TemporalScanner takes approximately 3000 measurements during the scan, retaining the highest, the most accurate, and discarding the rest, and with Exergen’s patented arterial heat balance method (AHB) with patented emissivity correcting infrared sensor system, eliminate the errors that NCITs cannot eliminate, resulting in a medically accurate thermometer backed by more than 100 peer-reviewed published clinical studies.5

Q:

What is the FDA’s view on non-contact infrared thermometers (NCITs)?

A:

The FDA’s own published studies, along with numerous published studies by others, show that NCITs are not accurate and cannot reliably detect fevers. The enforcement side of the FDA has not yet acted to issue warnings or recalls for NCIT thermometers.

Q:

Does the FDA consider Exergen TemporalScanners to be non-contact infrared thermometers (NCITs)?

A:

No. Exergen TemporalScanners have FDA 510(k) (K011291) market clearance that shows it is a device that works by gently contacting the forehead with a scan, and is not an NCIT.

Q:

Can Exergen TemporalScanners be used for screening for fever, which was a common use for NCITs during Covid?

A:

Yes. Exergen TemporalScanner professional models have been used for nearly 20 years in hospitals everywhere for fever screening where and when fast, medically accurate, and non-invasive fever screening is needed, and used about 100 million times per year.

NCITs are fast and non-invasive, but are never used for such fever screening because they are never accurate.

Q:

What is Exergen doing to encourage the FDA enforcement side to issuing warning letters or recalling NCITs, since NCITs are known to produce a false sense of security and are dangerous to public health?

A:

TBD..??

Check out our recent press releases regarding FDA findings to learn more:

FDA Posts Draft Transition Plan For Medical Devices That Fall Within Enforcement Policies Issued During The Covid 19 Public Health Emergency

April 11, 2022

Exergen calls on FDA to recall and prevent future sale of non-contact infrared thermometers whose inaccuracy is a danger to the public health The Food and Drug Administration (FDA) has given public access to its draft guidance entitled “Transition Plan for… Read more »

FDA Study Proves Non-Contact Infrared Thermometers (NCITs) are an Unreliable Temperature Screening Tool

February 22, 2022

FDA study highlights misleading labeling by NCIT manufacturers Since the start of the pandemic, non-contact infrared thermometers (NCITs) have become the primary tool used in public temperature screenings, even though extensive scientific research has proven that they do not produce… Read more »

US FDA Clinical Study Proves Non-Contact Thermometers Fail To Meet Accuracy Specifications

December 10, 2021

Exergen: FDA Study Reveals Misleading Labeling by NCIT Manufacturers Regarding Accuracy Since the start of the pandemic, non-contact infrared thermometers (NCITs) have been widely used as a screening method for fever detection in healthcare and public settings, as fever is… Read more »