Lord’s Mark Industries Limited, in collaboration with the Centre for Materials for Electronic Technology (C-MET), has advanced its AI-powered, radiation-free wearable breast cancer screening technology towards its final clinical trial stage, with trials planned across the USA, Great Britain and Europe. Developed using high-precision thermal sensors and AI-driven temperature mapping, the technology is designed to identify abnormalities associated with breast cancer in a non-invasive and radiation-free manner. The technology has undergone high-accuracy and conformity testing, with Lord’s Mark Industries Limited holding exclusive rights for its commercialisation. Phase 2 trials for detection of cancer at the cell level, targeting 98% accuracy, will commence from January 2027 in India, the USA, Europe and Great Britain. Various recognised medical device companies have expressed their excitement to be part of this trial, as this could change the way cancer treatment is approached once the technology is approved and recognised.
Lord’s Mark Advances AI-Powered Breast Cancer Screening Technology Towards Final Clinical Trials In USA, UK & Europe
Technical Committee Approves Final Clinical Trial Stage; Company Targets Regulatory Clearances and Commercial Launch by April 2027.
Breast cancer continues to be a major global health challenge, with 2.4 million women diagnosed and around 694,000 deaths recorded worldwide in 2024. Against this growing burden, the global breast cancer diagnostics market was valued at USD 5.9 billion in 2025 and is projected to reach USD 11.4 billion by 2033, growing at a CAGR of 8.8%. Imaging currently accounts for 51.6% of the market, while advances in mammography, 3D tomosynthesis, MRI, ultrasound, AI-assisted imaging, liquid biopsy and biomarker-based diagnostics are creating new opportunities for earlier and more accurate detection. With IARC projecting more than 3 million new cases annually by 2040, strengthening accessible and timely screening is becoming increasingly important.
The company has completed clinical trials in India , with the results demonstrating accurate identification of cases evaluated during the trials. The data generated through these trials will contribute to the technology’s ongoing clinical and regulatory evaluation. The Technical Committee has now approved the conduct of the final clinical trials across the USA, Great Britain and Europe , subject to the requirements of the respective jurisdictions.
The Committee is also of the view that the technology has the potential to identify breast cancer-related abnormalities at an early stage, subject to successful completion of the final clinical trials and independent verification.
The technology combines advanced thermal sensors with AI-based analytics to identify abnormal temperature patterns. Unlike conventional screening approaches involving radiation, the wearable is designed to be painless, portable and infrastructure-light. Being battery-operated, the technology can potentially be deployed even in areas with limited or no access to electricity, enabling breast cancer screening to reach hospitals, clinics, community centres, remote villages and underserved regions across India and global markets.
Potential to Transform Breast Cancer Screening
Following successful completion of the final clinical trials and regulatory evaluation, the technology could potentially offer an alternative approach to conventional breast cancer screening and expand access to screening across diverse healthcare settings.
The technology is currently progressing through regulatory evaluation in India, with CDSCO approval in process . The company is also working towards the applicable regulatory requirements for markets across Europe, Great Britain and the USA, including relevant European conformity requirements and US FDA regulatory pathways, as applicable.
The company is targeting completion of the final clinical trials and key regulatory milestones before March 2027 , subject to clinical outcomes, independent evaluation and regulatory timelines. Lord’s Mark is targeting commercial placement of the product by April 2027 , subject to successful clinical validation and applicable regulatory approvals.
Seeking Integration into National Screening and Insurance Frameworks
Lord’s Mark has also made representations to the respective authorities seeking consideration of the technology for inclusion in national breast cancer screening programmes.
Representations have also been made for consideration of insurance coverage through the Insurance Regulatory and Development Authority of India (IRDAI) . The objective is to explore mechanisms that could improve affordability and accessibility of breast cancer screening and encourage greater awareness and participation among women.
Sachidanand Upadhyay, Managing Director, Lord’s Mark Industries Limited, said, “The approval of the final clinical trial stage marks an important milestone in taking this technology from innovation towards broader clinical validation. With successful trials already completed in India and further trials planned across the USA, Great Britain and Europe, our objective is to establish a robust clinical and regulatory pathway for an accessible, radiation-free and affordable breast cancer screening solution. We remain focused on taking this technology to a global platform, subject to successful clinical validation and regulatory approvals.”
The collaboration with C-MET brings together C-MET’s research and development expertise with Lord’s Mark’s manufacturing and distribution capabilities, with the broader objective of developing and commercialising indigenous healthcare technology at scale.
Lord’s Mark intends to make the technology increasingly accessible and affordable, with the long-term objective of supporting wider breast cancer screening across India and international markets.
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