Category: mammography

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

Thermography Vs. Mammography: which is the best method to detect breast cancer?
December 19, 2020

According to the researches in 2019, it has been totaled that about 30% of cancers diagnosed in women is breast cancer. Breast cancer is the most commonly cancer type detected in American women. Fortunately, breast cancer detecting techniques have been provided women with a chance to fight against this beast. But this probing question that which method is the best one to use and why is still unresolved. In this article, we will take a look at what breast cancer screening is and find the differences between two famous and popular breast screening techniques: Thermography and Mammography and find out which method is the best one to use.

Breast Cancer Screening  

Breast cancer screening is an important factor in diagnosing breast cancer at an early stage before a person can display signs and symptoms of being sick. In breast cancer screening we use different screening methods (Mammography, Thermography or biopsy) to look into a person’s body and keep track of all the anomalies detected. Hence, we can have an early and promising treatment and healing.

Different types of screening methods

Since 1960s when there was a strong tendency to use computers in order to assist physicians in identifying the abnormal areas and having a second opinion besides the doctor’s detection, breast cancer screening methods have come a very long way. For a very long time, the best standard method was Mammography. Nowadays, other screening methods such as Thermography, biopsy, Ultrasound and etc. are introduced. In this article we will have a quick look at the differences between Mammography and Thermography and the benefits and drawbacks of using these methods in detecting breast cancer.

Mammography

Mammography is a breast cancer screening technique consisting of low-dose x-rays of the compressed breasts. Clinical organizations recommend having mammograms every year beginning at age 40. Before women can experience any signs of cancer such as lumps or tumors, mammography can diagnose it with self-examination. This method can also help women to find breast diseases such as a lump, pain or nipple discharge.

Benefits of getting Mammograms:

  • Cancer detection long before display of any symptom
  • Reducing the risk of dying from breast cancer by 19% overall

Drawbacks of getting Mammograms:

  • Exposure to radiation
  • Uncovering non-cancerous changes, resulting in false-positives
  • Less accurate detection for women with dense breast tissue and breast implants
  • Uncomfortable procedure, involving of breast compression

Thermography

Thermographies are thermal infrared images that are used to detect lesions in breasts. These Thermographies detect the temperature of the different regions of the breast. Regions with warmer temperature are more likely to contain tumors than normal tissue. Although thermal imaging is not definite and surroundings can affect its results but by using thermal images irregular thermal patterns that are not visible in normal mammograms can be easily recognized.

Benefits of Thermography:

  • It is non-invasive and painless
  • It is Non-radiative
  • Capturing the entire body: detecting the heat and radiation coming from the body
  • Getting a better sense of inflammation coming from teeth ( a hidden source of breast tissue abnormalities)
  • Measuring the temperature changes
  • Early detection up to 10 years before the cancer turns into a full-blown size

Drawbacks of Thermography:

  • Another imaging technique is likely necessary after this procedure to further investigate.

Thermography can be particularly a very useful alternative tool for screening the breast cancer annually, because then you can compare the current examination with previous tests and if there is any difference then it is even a more powerful predictor. If you haven’t had your test yet, you can contact us at www.aitalos.com and there we provide you with all the necessary information about breast cancer Thermography.

Thermography: Information and Overview
December 11, 2020

Breast cancer can happen in both men and women. But it is the most prevalent type of cancers that is diagnosed among women. It can be detected as a lump in breast tissue that is different from the rest. Other signs may include: tissue thickening/ one breast becoming larger or smaller/ nipple changing position / pain in part of breast or armpit and etc.

Biopsy of the affected area of breasts is used to diagnose most types of breast cancers. Moreover, there are other types of breast cancer that need to be examined with specialized laboratory methods. 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. Here we will take a look at what Mammography is:

“ Mammography is breast cancer screening using low-dose x-rays. Medical organizations suggest having mammograms every year beginning at age 40. Before women can experience any signs of cancer, mammography can diagnose it. This method can also help women to find breast diseases such as a lump, pain or nipple discharge.”

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. 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

 

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.

AI application for breast cancer Thermography

According to several studies, by using highly well-aimed and accurate soft-wares, breast cancer can be detected and treated at early stages of the disease. Several applications have been found in the medical profession for thermal imaging. In recent years, due to advancements in image processing techniques, Thermography has been able to achieve more than other methods such as Mammography. Thermography soft-wares (CAD) serves the need of physicians for an Al-guided support for breast cancer Thermography, which is an decisive factor in validating what they speculate, detecting what they potentially did not observe throughout the process and taking notice of highly dubious studies and researches that need to be brought to more attention.

What is the difference between Thermography and Mammography?
December 10, 2020

If you are a woman, your number one risk of cancer is breast cancer and traditionally one of the most preventive screening methods is Mammography. According to one research of 50 different cancer patients, 46 cases were detected using mammograms and 44 cases were detected using thermograms. The ones that were missed using mammograms, thermograms were able to identify and the cancer cases that were missed using thermograms, mammograms could detect. Thus, many people prefer to use both of the methods in order to catch all the cases. (Dr. Troy Spearl, Synapse: Center for Health and Healing)

In this paper, we examine the differences between mammography and thermography and have a look at all the pros and cons of both methods.

Doctor and patient making a mammography

Mammography is breast cancer screening using low-dose x-rays. Medical organizations suggest having mammograms every year beginning at age 40. Before women can experience any signs of cancer, Mammography can diagnose it. This method can also help women to find breast diseases such as a lump, pain or nipple discharge. now, let’s have a look at the cons of Mammography:

The cons of Mammograms:

  • Stressful situation that patient experiences doing mammography
  • Over-diagnose of Mammograms: a lot of people go through cancer treatments even when they did not need to
  • Late identification: it would be better if we could identify breast cancer much earlier
  • More exposure to unnecessary radiation
  • More invasive

So, even though this method can serve as a screen to show breast cancer, it is not the best method to use.

When comparing the pros and cons of Mammography and Thermography, the actual cons of Thermography are only the cases that are missed and if you use ultra-sound method combined with Thermography you can check both sides (anatomical and physiological) of an image. But when it comes to the pros of Thermography, it can really check for the things are not visible in normal mammograms and also it can identify some of the certain types of inflammatory cancers even before they show up. Here, we will take a look at the pros of Thermography:

The pros of Thermography:

  • It is non-invasive and painless
  • It is Non-radiative
  • Capturing the entire body: detecting the heat and radiation coming from the body
  • Getting a better sense of inflammation coming from teeth ( a hidden source of breast tissue abnormalities)
  • Measuring the temperature changes
  • Early detection up to 10 years before the cancer turns into a full-blown size

Thermography can be particularly a very useful alternative tool for screening the breast cancer annually, because then you can compare the current examination with previous tests and if there is any difference then it is even a more powerful predictor.

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