Category: FAQs

FDA: Thermography is no substitute for Mammography!
January 2, 2021

FDA: “There is no valid scientific data to show that thermographic devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition, including the early detection of breast cancer or other diseases and conditions”.

The FDA is aware that health spas, homeopathic clinics, mobile health units, and other health care facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis.

The FDA has received reports that these types of facilities provide false information that can mislead patients into believing that thermography is an alternative or better option than mammography. The FDA is concerned that people will believe the misleading claims about thermography. Read below to find out more about this topic.

Breast Cancer Screening: Thermography vs. Mammogram

Since 1990s, several methods have been used for the early detection of breast cancer, such as mammography and MRI. Mammography is the standard method for early detection of breast cancer, but it has one main limitation: that is, it may produce a large number of false positives. In contrast, respective standard screening techniques are used for early detection of breast cancer such as Thermography. Thermal infrared images are used to detect lesions in breasts. Since the normal temperature range of human body is between 36.5∘C to 37.5∘C, by using this technique, thermal infrared cameras are able to capture the variation of temperature between normal and abnormal breast tissues. These Thermograms detect the temperature of the different regions of the breast. Regions with warmer temperature are more likely to contain tumors than a normal tissue. This technique has several substantial benefits:

  • It is less expensive than the mammography and magnetic resonance imaging (MRI)
  • It is non-contact, non-invasive
  • It is non-radiative
  • It is a safe diagnostic procedure, in which patients feel no pain
  • This method can be used from far way
  • It is possible to simultaneously monitor a large area of the population
  • Interpretation of thermogram’s colors is easy and fast.
  • This method only records natural radiation from the surface of the skin and there is no trace of harmful rays, so is suitable for long-term and repeating use.
  • It is a fast way to monitor and observe the dynamic changes in temperature.
  • Early detection up to 10 years before the cancer turns into a full-blown size

The tool, however, has been cleared by the FDA only as a supplement to primary diagnostic tests such as mammography and not as an substitute. Helen J. Barr, M.D., director of the Division of Mammography Quality Standards in the FDA’s Center for Devices and Radiological Health states that: “You should not rely solely on thermography for the screening or diagnosis of breast cancer.”  

The agency affirmed that individuals who substitute thermography for mammography may miss the opportunity to detect cancer at its earliest and most treatable stages. The agency wrote in its safety communications statement that: “We are committed to protecting and promoting access to safe and effective breast screening devices.” 

The United States Food and Drug Administration currently accept applications for thermographic cameras as Class I Medical Devices. These are described as devices that hold no potential risk and have the lowest level of regulatory control. Consequently, Experts highly recommend that the technique should only be used in connection with other breast cancer screening processes such as mammography. Moreover, it provides suggestions for individuals getting breast cancer screening to be aware of thermography as well as recommendations for health care providers to educate patients about the limitations of thermography.

Recommendations for People Getting Breast Cancer Screening  

  • Be aware that thermography is not a substitute for regular mammograms and should not be used in place of mammography for breast cancer screening or diagnosis.
  • Have regular mammograms according to screening guidelines or as recommended by your health care provider.
  • Follow your health care provider’s recommendations for additional steps to diagnose breast cancer such as a clinical breast exam, other breast imaging (for example, breast ultrasound or MRI), or breast tissue biopsy.

Recommendations for Health Care Providers

  • Educate patients about the limitations of thermography. For example, the high false negative and false positive rates of thermography can provide misleading information that could result in a delayed diagnosis or unnecessary medical follow up.
  • Discourage the use of thermography to diagnose or screen for breast cancer.
  • Talk to patients or caregivers about safe and effective ways to screen for breast cancer including the benefits and risks of available testing options.

Reporting Problems to the FDA

If you experience an injury or adverse event with thermography, the FDA encourages you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program. Please include the following information in your reports:

  • Device Name (Brand Name)
  • Manufacturer’s Name
  • Details of Adverse Event and Medical and/or Surgical Interventions (if applicable)

Prompt reporting of adverse events can help the FDA identify and better understand the risks related to the use of medical devices.

Additional Resources

Contact Information

If you have questions about thermography, please contact www.aitalos.com or visit our linkedIn page: https://www.linkedin.com/company/ai-talos

How Thermography works
December 28, 2020

Thermography is a breast screening technique that uses thermal infrared images for detecting breast cancer in women. It is non-invasive and painless and does not involve the compression of breasts. Although thermal imaging is not definite and surroundings can affect its results but by using thermal images irregular thermal patterns can be easily recognized by detecting increases in temperature. Thermography does not involve any radiation, instead an ultra-sensitive camera is used to create high-resolution, infrared or heat images of the breasts.

 

How thermography works

When tumors develop, cancer cells grow. These cells need additional blood to reproduce. So the blood flow increases for this purpose, and the skin in that area will become warmer. By using digital infrared imaging, thermography can detect subtle changes in the breast by revealing areas of heat and cold.

What to expect

Thermography test is involved of the following procedure:

  1. It should take place in a doctor’s office or a healthcare clinic
  2. The patient will stand about 6–8 feet away from the camera
  3. They will have a painless, noninvasive test that does not involve compressing the breasts
  4. The procedure will last approximately 15 minutes
  5. Doctor will look for any differences between the breasts

What thermography detects

A thermograph will show changes in body and skin temperature, which may be a sign of increased metabolic activity or blood flow in one particular area of the body. If the thermography detects any abnormalities, this may not necessarily be cancer and the person should seek further screening to confirm that a lump is present.

Benefits

Reasons why thermography is wide-accepted among the medical community is listed below:

  • Thermal imaging is non-contactand non-invasive
  • The method can be used from far way
  • It’s possible to simultaneously monitor a large area of the population
  • Interpretation of thermogram’s colors is easy and fast.
  • This method only records natural radiation from the surface of the skin and there is no trace of harmful rays, so is suitable for long-term and repeating use.
  • Finally thermography is a fast way to monitor and observe the dynamic changes in temperature.

Risks

This method is non-invasive, non-contact and does not appear to pose any physical risks to a person. In addition, it includes no compression of your breasts but the test has a high rate of false-positives and false-negatives meaning that this method is not sufficiently sensitive as a diagnostic tool. Thus, another imaging technique is likely necessary after for further investigation.

In order to get more information on Thermography screening for breast cancer detection please visit our website at www.aitalos.com. AI talos is an AI-powered screening app for detecting breast cancer using thermal infrared images. By using deep learning methods and the cutting-edge technology that we have, we’ve been able to improve detection to 95.3 percent which is 30 percent better than human operators.

FAQs about Thermography
December 19, 2020
  1. What is breast cancer Thermography?

Thermographies are thermal infrared images that are used to detect lesions in breasts. These Thermographies detect the heat pattern and blood glow of the different regions of the breast. Regions with warmer temperature are more likely to contain tumors than normal tissue. The infrared thermal imaging method can analyze breast cancer using dynamic Thermograms and also it can selectively optimize the contrast in areas of dense tissues in young women.

  1. What are the advantages of Thermography?

This techniques has respective substantial benefits:

  • It is less expensive than the mammography and magnetic resonance imaging (MRI)
  • It is non-contact, non-invasive
  • It is non-radiative
  • It is a safe diagnostic procedure, in which patients feel no pain
  • This method can be used from far way
  • It is possible to simultaneously monitor a large area of the population
  • Interpretation of Thermogram’s colors is easy and fast.
  • This method only records natural radiation from the surface of the skin and there is no trace of harmful rays, so is suitable for long-term and repeating use.
  • It is a fast way to monitor and observe the dynamic changes in temperature.
  • Early detection up to 10 years before the cancer turns into a full-blown size

  1. Is it an alternative method for Mammography?

Thermography is not an alternative method for Mammography. It is less sensitive than Mammography and can sometimes find cancerous results that are not present. Mammography has also false positives and can miss cancerous cells but experts say you should not substitute it for Mammography. The combination of two methods is likely necessary for further investigation.

  1. Who should get Thermography?

For women under the age 50 and those with dense breasts.

  1. How is the procedure going?
  • Do not wear perfume or deodorants on the day of the testing
  • You will get undressed so that your body become acclimated to the temperature of the room
  • You will stand in front of the imaging system
  • The technician takes a series of 6 images ( front and side views) of your breasts
  • The timing will be about 30 minutes
  • The doctor will analyze your images and you get the result within a few days after the test
  1. What are the possible side effects?

This method is non-invasive, non-contact and non-radiative. In addition, it includes no compression of your breasts but the test has a high rate of false-positives meaning that another imaging technique is likely necessary after this procedure for further investigation.

  1. Should I get a Thermogram or Mammogram?

Before taking a breast cancer screening test ask your doctor some questions about your high risk of getting breast cancer, the risks and benefits of getting these tests, what happens if you get false-positives and ask whether you just need Thermography or other additional breast cancer screening tests.

In order to get more information on Thermography screening for breast cancer detection please visit our website at www.aitalos.com. There you can use our top-notch AI guided software for breast cancer detection using thermal images for a thorough self-examination.

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