A radiation-free wearable breast cancer screening device powered by artificial intelligence now moves toward its final clinical trial stage, with testing slated across the United States, United Kingdom, and Europe. Lord’s Mark Industries Limited developed the technology alongside the Centre for Materials for Electronic Technology (C-MET), positioning it as a potential alternative to mammography and other radiation-based screening methods.
Breast cancer remains one of the deadliest health threats for women globally. In 2024 alone, medical professionals diagnosed 2.4 million new cases and recorded roughly 694,000 deaths worldwide. Meanwhile, the breast cancer diagnostics market reached USD 5.9 billion in 2025, with projections showing it climbing to USD 11.4 billion by 2033. Imaging dominates that space, accounting for 51.6% of current market share.
The technology relies on high-precision thermal sensors paired with AI-driven temperature mapping to detect abnormal patterns associated with breast cancer, eliminating radiation exposure entirely. Lord’s Mark holds exclusive commercialization rights. Battery operation means the wearable can function in remote locations without reliable electricity, extending screening access to villages, community centers, and underserved regions.
Phase 2 trials targeting 98% accuracy will launch in January 2027 across India, the USA, Europe, and the UK. The Technical Committee has greenlit final clinical trials subject to jurisdictional requirements in each region. Indian trials already demonstrated accurate identification of evaluated cases.
The company currently pursues CDSCO approval in India, alongside parallel regulatory pathways including European conformity requirements and US FDA processes. Lord’s Mark aims to complete final trials and key regulatory milestones before March 2027, with commercial product placement targeted for April 2027, contingent on successful validation.
Sachidanand Upadhyay, Managing Director of Lord’s Mark Industries Limited, confirmed the final trial approval marks a significant step toward broader clinical validation. He emphasized the goal of establishing a rigorous clinical and regulatory pathway for an affordable, radiation-free screening solution on a global scale.
Lord’s Mark has filed representations seeking inclusion in national breast cancer screening programs and insurance coverage through India’s Insurance Regulatory and Development Authority (IRDAI). If successful, these moves could dramatically improve affordability and participation rates among women who currently face barriers to screening access.
