(https://www.fda.gov/medical-devices/safety-communications/fda-warns-thermography-should-not-be-used-place-mammography-detect-diagnose-or-screen-breast-cancer).
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:
Thermalytix is available only in India at this time and usage in India does not fall under the purview of the above mentioned US FDA communication. We are under the process of getting an FDA clearance for our AI-based solution as well. .
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.
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.
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.
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.
Thermography 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 and 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 70% higher positive predictive value than Thermography.
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.
Ideal time period for a woman is from ovulation to the onset of menstruation.
Please 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.
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.
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.
Yes. US FDA has approved Thermography as an adjunctive screening modality for breast cancer screening. However, FDA warns that Thermography-alone cannot be used for breast cancer screening test.
NIRAMAI Thermalytix is an AI-based solution that uses thermal images as inputs. It is cleared by Indian regulatory authority and not yet cleared by US FDA.
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 daily-rental basis. Please drop us a note on contact@niramai.com . We can arrange one free pilot screening camp for you..
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.
Early detection is very important to have a good cure. Since thermography is not harmful and can catch cancer earlier than any other modality, it is recommended to have at least two thermographic scans per year.
Patients suffering from colds, influenza, fever and similar isues, they should not be scheduled for a screening on the day. Alcoholic beverages, coffee, tea or colas containing caffeine should not be consumed for twelve hours prior to the test. Hot or cold beverages 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.
Statistics from World Health Organization (WHO) shows that the incidence rates for women below 40 years is increasing. This would worsen in future due to stress, changes in lifestyle and increase in pollution. All women above 25 years are therefore recommended to undergo breast screening using thermography.