Early detection is a vital, life-saving approach to combat breast cancer. However, high costs and limited access to screening prevent many women worldwide from benefiting from early diagnosis. Niramai Health Analytix is an Indian health-tech startup founded in 2016 by Dr. Geetha Manjunath. The company addresses these challenges by using innovative AI and thermal analysis, offering a non-invasive and minimally invasive method to detect breast cancer early.
Niramai stands for “Non-Invasive Risk Assessment with Machine Intelligence.” It is named so in Sanskrit, meaning illness-free. It is called so in Sanskrit, which translates to illness-free. It is Sanskrit in nature, which translates to illness-free. This highlights its primary objective of providing affordable medical services to women. Niramai is a provider of services to over 200 hospitals in 30 cities in India. Its technology is tested on thousands, and it has been proven to be practically effective.
Additionally, Niramai joined the list of Top 20 Technology Pioneers in the World Economic Forum in 2024. The innovative character and compassion of Niramai have placed it in an even better position because it is a steadily growing company in 2025.
This article explores Niramai’s technology, its advantages, and success cases, explaining why the company is a leader in the field of AI health-tech cancer detection. In Niramai, there is an inoculation of women and clinicians, and people’s lives are changed.
What Is Niramai & How Does Thermalytix Work?
Origins and Mission
Niramai Health Analytix was a start-up project in Bengaluru, India. Dr. Manjunath was a computer science professional who developed gaps in the health of women. In 2016, Niramai Health Analytix was established by Geetha Manjunath (a doctor) and a co-founder, Nidhi Mathur, to solve the issue of late detection of breast cancer in India.
Dr. Manjunath is a computer scientist who has a PhD in AI. Two relatives of his died of breast cancer when it was too late. That personal motivation helped shape the company’s mission: “take this test to every woman on earth and eliminate deaths from breast cancer.”
The company bootstrapped early on. By 2017, it had launched Thermalytix, its flagship tool. Niramai grew fast. It collaborated with Google Cloud to scale up AI. In the year 2025, Niramai made new records. Its SMILE-100 system got FDA clearance for breast health checks. This green light opens U.S. doors.
Niramai isn’t just tech. It’s people-focused. Teams train local health workers to use its portable devices. This boosts screening in remote spots. For example, Niramai joined forces with Action Pink, a German NGO, in early 2025. Together, they spread awareness in Europe and Asia.
Funding fuels Niramai‘s fire. Crunchbase notes rounds that back R&D, and investors see value in its 36 patents on thermal AI. These protect ideas like multi-modal imaging for dense breasts. Niramai also shines in awards. From Harvard case studies to peer-reviewed papers, its cred stacks up.
However, Niramai faces hurdles. Scaling in low-resource areas needs logistics. Yet, it adapts. Mobile units bring Niramai tech to villages. Uptake in low-middle-income countries? Just 2.2% for screenings. Niramai pushes to raise that. Its low-cost technology—95%—makes it cheaper than mammograms.
Concisely, Niramai is a combination of AI intelligence and street-level nurture. It’s not a gadget seller. This mindset drives Niramai forward.
Technology Behind Thermalytix
In its simplest form, Thermalytix is an AI system that uses high-resolution thermal imaging of the chest to compare small patterns of temperature changes, which could indicate abnormal blood vessels or tumors.
The simplistic flow of its operation is below:
A woman enters a screening room (private, no touch, no contact).
A thermal sensing device captures infrared heat data across the chest.
The AI analyzes ~400,000 temperature points per scan.
Algorithms detect anomalies in vascular structure, hotspots, asymmetries, and thermal gradients that may suggest malignancy.
A breast health score / B-score (1 to 5) is calculated. A score of 4 or 5 would probably result in referral to additional imaging (mammogram, ultrasound, MRI) and biopsy as necessary.
Radiologists review the AI output and advise follow-up.
Niramai’s team argues that Thermalytix is not conventional thermography, which relies on manual interpretation of thermal images. Instead, the AI uses temperature maps and advanced machine learning to deliver more sensitive, consistent, and less subjective outputs.
Because of its higher thermal sensitivity (≈0.02°C vs ~1°C in standard thermography), the system can theoretically detect abnormalities earlier than what a human eye might catch.
Further, Niramai has come up with such products as SMILE-100 (a thermal imaging device to test breast health, approved by the FDA) and a mobile screening device, Mythri, to use in the outreach programs.
Key Technical Advantages
Early Stage Detection: This is when cancer can be diagnosed at stage 0 or stage 1, and therefore, a less invasive and successful treatment process can be achieved.
Portable and Low-Cost: It is compact, user-friendly, and far less expensive than mammography equipment, which will increase availability in tier 2 and 3 towns in India.
Privacy and Comfort: This will be achieved by ensuring that nobody sees or handles the patient during the test, which is critical to its acceptance, especially among rural women.
FDA Cleared: The SMILE-100 adjunct test of Niramai was FDA-cleared, confirming its usefulness in clinical practice.
Evidence & Clinical Validations
For a technology like Niramai’s, evidence matters. Fortunately, there’s growing clinical literature.
Key Studies & Findings
A state-wide study in Punjab screened ~15,069 women over 18 months using Thermalytix. The recall rate was ~3.1%, and among those who underwent follow-up imaging, 27 cancer cases were confirmed (positive predictive value ~81.8%).
A meta-analysis of three clinical studies on 1,187 women (463 under age 45) showed that Thermalytix had a pooled sensitivity of ~88.3% and a specificity of ~84.7%. With young women, sensitivity was 90.7, specificity 82.1.
The article is a multicenter study published in BMJ Open (2021) that compared Thermalytix with standard screening methods, such as mammography, ultrasound, and clinical exams. It was equally sensitive and specific for both public and non-public women.
An observational clinical efficacy study on symptomatic and asymptomatic women validated the AI’s performance relative to mammography and ultrasound.
According to a recent prospective blinded assessment (preprint, 2025), there are still attempts to find validation with the help of a rigorous design.
All these studies suggest that Niramai / Thermalytix could succeed, especially in areas where mammography isn’t practical or feasible, such as in dense breast tissue or among younger women. However, the evidence has yet to be fully established.
Why Niramai Has a Lead (and Where It Still Needs to Go)
Let’s be blunt: Niramai is not a silver bullet. But it has advantages that make it compelling. And it has challenges it needs to overcome.
Strengths & Advantages
Non-invasive & Radiation-FreeWomen either miss screenings because of radiation fear or are uncomfortable. Niramai offers a “no touch, no see, no pain, no radiation” approach.
Better for Dense Breasts & Younger WomenMammography sensitivity drops sharply in dense breast tissue. Thermalytix shows relative improvement in these cases. In younger women (<45), clinical studies report sensitivity ~90%+.
Portable & ScalableDevices can be carried in a backpack and deployed in rural or remote areas, where mammography infrastructure is missing.It fits screening camps, corporate health checks, or mobile health units.
Affordability & Lower CostMammography costs (in India) are often 3,500–5,000 INR or more; Niramai claims its test costs 1/10th of that in some contexts (350–500 INR) and has minimal operator requirements.Low operator training barriers help scale in low-resource settings.
Automated & ObjectiveAI removes human subjectivity from thermal images. The system computes consistent risk scores, reducing inter-observer variability.
Privacy & Cultural AcceptabilityIn conservative or rural settings, privacy matters. The test is done without anyone seeing or touching the patient. That helps adoption.
Niramai vs Traditional Screening Methods: A Comparison
FactorNiramai (Thermalytix)MammographySelf-examRadiation RiskNoneYesNonePain/DiscomfortPainlessSometimes painfulPainlessAge LimitationAll agesGenerally over 45 yearsAll agesPrivacyFully privateLess privatePrivateEarly DetectionStages 0/1After mass developmentAfter mass detectableCostVery lowHighNo costAccessibilityPortable, easy in rural areasLimited in rural areasEasy, but low accuracy
Niramai Competitors and Market Position
Among the numerous companies providing AI-assisted cancer screening in health-tech, Niramai is the first to address the concerns of Indian healthcare.
Top Competitors
AILIS: Focuses on dynamic parametric imaging for breast cancer risk assessment.
Thermaiscan: Offers predictive medicine and AI-powered breast cancer prescreening.
Prognica Labs: Specializes in AI for early cancer detection within the healthcare sector.
Despite these alternatives, Niramai remains ahead due to its:
Deep clinical validation in India’s healthcare landscape
Patent-protected technology tailored for affordability and rural outreach
Recognized partnerships with leading hospitals and diagnostic chains
Risks, Limitations & Open Questions
Not a Replacement for Diagnostic Imaging
Thermalytix is a screening tool, not a diagnostic confirmation tool. Even positive cases should undergo mammography, ultrasound, or MRI.
False Positives / Recall Rate
Any screening test has trade-offs. Recall rates in real studies are ~3% (in Punjab). Some false positives may burden imaging services.
Generalizability Across Populations
Most large studies are in Indian populations. Whether performance holds across ethnicities, climates, breast sizes, and other factors is yet to be fully validated. The Welsh health technology assessment flagged the need for more diverse prospective trials.
Regulatory Acceptance & Clinical Acceptance
The adoption of it in Western health systems will require large randomized controlled trials, regulatory approvals (such as FDA, CE, etc.), and compliance with local medical device regulations.
Integration/ Workflow complications
The health systems will need to establish AI screening as an additional procedure, ensure follow-up compliance, manage referral logistics, and protect data.
Cost of Scale & Maintenance
Even if scanning is low cost, scaling devices, training personnel, servicing the devices, and handling data pipelines (server, cloud) have overhead.
Long-term Impact on Mortality
Ultimately, a screening technology must show that it leads to reduced mortality (not just better detection). That evidence typically comes after many years.
Deployment & Business Strategy
The Implementation of Niramai
Niramai collaborates with hospitals, diagnostic chains, NGOs, and government agencies to establish units.
They conduct screening camps and outreach programs, especially for underserved communities.
To enhance the uptake, they cross-sell to corporate wellness schemes (e.g., on office campuses).
They also build mobile units to reach rural populations.
Public health adoption is increasing: For instance, Punjab’s government is launching Thermalytix devices in primary care centers.
Business Model, Funding & Scaling
Niramai likely has a device + software + service model: selling or leasing hardware, charging per screening (software/analytics), and maintenance.
Venture investors have increased the amount of funds raised by the company.
To scale sustainably, it must lower per-screening cost, grow throughput, reduce errors, and integrate with local health systems.
The company’s global ambitions entail regulatory approvals and validation in different geographies.
Future Outlook & Recommendations
What Niramai Should Focus On
Large, Multinational Clinical Trials
To be accepted in the rest of the world, Niramai must conduct randomized trials of the results (early detection, mortality) and make sure that the populations are represented.
Drug Regulatory Clearances and Standards Compliance
Increase FDA, CE, and local health authority clearances. Increase quality systems, audit, and documentation.
Enhance Artificial Intelligence and its Diversity Data
Keep the socio-economic data (mainly the size of the different breasts, the variety, and the differences in climate, etc.) constantly enhanced in the algorithms to improve their general applicability.
Reduce Recall / False Positive RatesAdjust to fine-tuning levels to ensure high sensitivity and a low number of unwarranted referrals.
Integration Workflow & Referral Ecosystem
Develop follow-up imaging, patient tracking, telemedicine referrals, and data management systems.
Scale Generation & AffordabilityReduce old hardware prices, simplify software platforms, and lower costs of government health programs.
Enlightenment and SchoolingUnless women use the best technology, they will not succeed. They need to provide motivation, collaborate with NGOs, and conduct large-scale campaigns.
Potential Impact
Even in the case of Niramai, the impact will be tremendous:
More screening in rural and low-resource areas
The higher Bruce is in terms of age and density of his breasts
Reduced burden on expensive imaging infrastructure
Lower mortality and morbidity from breast cancer
A scalable, replicable model for AI health tech in other disease areas
FAQs on Niramai and Breast Cancer Screening
1. What is Niramai Thermalytix, and how does it detect breast cancer?
Thermalytix, analyzes the thermal images of the breast produced by Niramai. It detects abnormal heat indicating tumors. The process: find a pose, and AI processes the images in seconds. It is non-invasive and identifies risks early, even in dense tissue.
2. Is Niramai radiation-free, and is Niramai screening safe?
Yes, fully. Niramai does not use X-rays. There is no evidence in the labels of the various radios they have that they are safe for all, including expectant mothers.
3. How accurate is Niramai compared to traditional mammograms?
Niramai is as sensitive as mammograms, with up to 98% trials being successful. It is best in dense breasts, which X-rays fail in. The initial study conducted in Punjab in 2025 showed that it identified 10% more cases than previous studies.
4. What is the cost, and where can I get a Niramai screening?
Costs? Under $5 in India—95% less than mammograms. Available at 200+ hospitals in 30 cities. Check niramai.com for spots. Mobile units serve rural areas.
5. Can Niramai be used for self-screening at home?
Not yet fully, but Niramai‘s Mythri app enables guided home checks with phone attachments. Pro scans are recommended first. Future wearables may bring complete DIY options.
Conclusion
Niramai, with its Thermalytix platform, is advancing AI-health technology by striving to make early cancer detection accessible to women who would otherwise never be screened.
Being non-invasive, radiation-free, portable, affordable, and compatible with AI, it is a natural choice for low-resource settings. The clinical evidence is growing but remains inconclusive across all groups.
As a new global innovation, Niramai must demonstrate long-term improvements in maintaining quality of life, scalability, and regulatory and clinical approvals across different regions to establish itself as an international standard. The outlook is promising, though.
If you like, I can prepare a competitor landscape (other AI/thermal cancer screening startups) or a roadmap for Niramai to succeed globally. Do you want me to build that next?