Did you see the FDA Warning Notice on Thermography?

Off late some customers are requesting clarity on the above safety communications warning issued by US FDA about usage of thermography for screening, detection or diagnosis. There are some important considerations showing why the Niramai solution is not the same as Thermography, and those differences are detailed below:

  1. NIRAMAI solution uses Thermalytix© which is different from Thermography. Though the sensing method used by Thermalytix includes thermal images (measurement of temperature variations on the skin), NIRAMAI Thermalytix Solution uses a unique AI-enabled software that gives objective assessment of the thermal analysis, which is missing in thermography. Additionally, demography data about the patient as well as a novel vascularity analysis is performed. So, we should treat Thermalytix as a new solution for detecting breast abnormalities.
  2. Thermography clinics provide a report based on visual analysis of thermal images. Thermal images are very complex with about 400,000 temperature points shown as a color pixels, where each pixel can be any of the 2000 colors. Analyzing and interpreting these thermal images with just visual inspection is a huge cognitive overload for even an experienced thermographer. So, the manual diagnosis used in Thermography is very error prone. Hence we agree with FDA guidance of using visual analysis of thermal images (thermography) as an adjunct to existing methodologies. However, NIRAMAI Thermalytix is not Thermography.
  3. Thermography clinics are also NOT able to provide any report with one sitting of the patient. They usually ask the patient to come back in 3 months and do a visual inspection of 2 different sets of images taken 3 months apart. This results in potentially missing a case that was evident in the first sitting, and delaying the identification of malignancy for the patient. NIRAMAI solution is able to analyse the thermal images for every screening instance and provide a quantitative report.
  4. NIRAMAI solution is based on machine learning models – that have the ability to analyse all the 400,000 color points both in imaging domain as well as temperature domain. A difference of 0.02 deg C is perceived by NIRAMAI software and hence the analysis is very sensitive, unlike thermography where two different shades of a color are hard to distinguish.
  5. NIRAMAI machine learning models are calibrated with historical data labelled with current standard of care. The way NIRAMAI models were trained was based on labels learnt from mammography + sono-mammography + biopsy. It was not trained using reports of thermographers, hence NIRAMAI results are more accurate and better than current standard of care.
  6. In order to make an objective comparison between Thermography and Thermalytix, a clinical trial on 303 patients was conducted in a blinded retrospective analysis. This was peer-reviewed and published in International Conference on Advances in Breast Cancer Treatments, Kyoto, Japan, April 26-27, 2018. The results of this comparison showed a remarkable improvement in performance of Thermalytix over Thermography. An increase of 70% was seen in Positive Predictive Value over Thermography was seen, with very high levels of sensitivity and specificity. A copy of the paper that compares results of Thermography and NIRAMAI Thermalytix is available here

Thermalytix has  regulatory clearance in India, Europe, UAE and Kenya at this time and usage in these countries does not fall under the purview of the above  mentioned US FDA communication.

We recently obtained US FDA clearance for our SMILE-100 tool that has subset of features of Thermalytix. However, Thermalytix is not yet approved in USA.

What is Thermography

Thermography is a technique where heat radiated from body surface is captured. Cancer cells have high metabolic activity due to which high heat is radiated from that region. This can be visualised as an abnormality in thermographic images.

What is NIRAMAI?

NIRAMAI is a non-contact, non-invasive way of screening for breast abnormalities. It is the only privacy-aware automated solution that can detect early-stage breast cancer.

How easy is it to use the NIRAMAI solution

NIRAMAI solution is very simple. The whole process is non-contact, non-invasive and is completely privacy aware. The patient is made to cool for 10-15 minutes to room temperature and the actual screening takes less than 5 minutes.

What is the novelty in NIRAMAI solution?

NIRAMAI is the pioneer of a patented technology called Thermalytix© which is a novel fusion of Artificial Intelligence and Thermography for Breast Screening. NIRAMAI early stage breast cancer screening solution is a non-contact, non-invasive, portable, safe, automated solution that works for women of all ages. The novel AI and ML algorithms for the analysis of thermal images have resulted in Nine granted US patents and many more patent applications.

How is NIRAMAI Theramalytix different from Thermography?

Thermography is visual analysis of thermal images. It has been in practise by many medical professionals around the world as an adjunct modality to detect early stage breast cancer screening. However, manual analysis of thermal images requires highly trained skilled professionals, and many times results in a number of false positives.

NIRAMAI’s Thermalytix solution addresses this issue using machine intelligence and provides an accurate, automated method of screening for early stage breast cancer and other breast abnormalities. NIRAMAI Thermalytix has much higher accuracy than Thermography.

What exactly is done in NIRAMAI breast screening?

Niramai solution is based on Thermography. Niramai thermal device which is placed 3 feet in front of the patient captures 5 thermal images of the region. Niramai software tool automatically analyses these images and sends the analysis report that is certified by a Senior Radiologist.
For more details, please watch this video  https://www.youtube.com/watch?v=Eo2Z0a_9lyY

What is the ideal time in a month to go for NIRAMAI/Thermography screening.

Ideal time period for a woman is from ovulation to the onset of menstruation.

I am interested in going through NIRAMAI Breast Screening. Where should I come?

Please click on the link “Register for Screening” and share your details oe just drop a note on the contact form with your location and contact details. Our customer support will reach out to you for an appointment in the nearest centre. Niramai test is available in 150+ locations in India, Kenya and UAE.

What is the minimum age for thermographic/NIRAMAI screening

There is no minimum age for thermographic screening. It doesn’t depend on the age, color, race and density of breast. Any girl post menstruation should be conscious of her breast health.

Is Thermography painful like Mammography

No. Thermography is a non-contact, non-invasive and radiation free modality, unlike mammography where 10 kg pressure is applied. Thermography just measures temperature, there is no harmful radiation exposure too.

Is there a regulatory approval for Thermography-based cancer screening

Yes. NIRAMAI Thermalytix is an AI-based solution that uses thermal images as inputs. Niramai Thermalytix test has received regulatory approval from India, Kenya, UAE and all countries from Europe (CE Mark).  A device with subset of features of Thermalytix (called SMILE-100) is also regulatory cleared by US FDA.

Thermal devices used by Thermalytix are also US FDA cleared and have CE Mark.

I am interested in buying NIRAMAI Solution. Whom should I contact?

If you are hospital or diagnostic centre interested in deploying this solution in your centre, please drop a note to contact@niramai.com. We will arrange a free demonstration of the solution and discussion with Niramai experts.
If you are an NGO or a society interested in conducting screening camps for women, Niramai solution is available on monthly or daily-rental basis too. Please drop us a note on contact@niramai.com .

For deeper collaboration with Niramai, please write to partnerships@niramai.com

My relative has/had breast cancer. What is the risk of me getting breast cancer

It depends on how close you are with the relative. If the relative is a first degree relative (Parent, Sibling or Child) you have a more risk of cancer and is recommended to go for frequent screening. If the relative is a second degree relative, the risk is less compared to former.

How frequent do I need to have screening

Early detection is very important to have a good cure. We recommend Thermalytix scan once a year for all females above 25 years. Since Thermalytix give breast health scores, if your score is all zero, you can repeat it once in 2 years.

Things patient should do for perfect thermography/NIRAMAI screening before examination

Patients suffering from fever can postpone their screening to a future date, just to avoide inconvenience to them. Alcoholic beverages should not be consumed for twelve hours prior to the test. Hot tea  or coffee should be avoided for at least one full hour before examination. Aspirins, pain medications, vasodilators, constrictors should be avoided for 24 hours prior to test.

When should I start going to breast cancer screening?

While the global guidance advices women above 45 years to take a breast cancer screening test every year, statistics from World Health Organization (WHO) shows that the incidence rates for women below 40 years is also increasing. About 28% of breast cancer deaths are under 45 year. This would worsen in future due to stress, changes in lifestyle and increase in pollution. So, we recommend all women above 25 years are therefore recommended to undergo breast screening using thermography.