11/04/2025
Dear Thermographers,
We are reaching out with an urgent message concerning a company that has recently contacted several members of our community. The IAMT is deeply concerned about a company based in India, promoting AI-Powered Breast Cancer Screening Test.
If you have received any invitations or communications from this company or from people promoting it, we strongly advise you to proceed with extreme caution.
Key Concerns:
Misleading Claims: This company claims to provide FDA approved AI generated breast reports but there are currently no FDA approvals for AI generated Medical Thermography reporting, for them or anyone else.
FDA 510(k) Misrepresentation: While this company has obtained FDA 510(k) clearance, this does not authorize them to claim capabilities related to breast cancer diagnosis or AI-based image interpretation. These claims are misleading and not compliant with FDA regulations.
Non-Compliant Terminology: As IAMT-trained professionals, you are aware that terms such as “Breast Cancer Detection,” “Early Detection,” “Screening,” and “No Radiation” are not FDA-compliant when used in marketing or clinical claims for thermography. Many people do, but we assure you, it is not legal or FDA compliant.
Expert Consultation: The IAMT consulted a respected regulatory firm specializing in FDA 510k submissions. They were alarmed by the company’s current claims. They confirmed that a 510 k clearance does not cover AI interpretation, which would require a separate and rigorous FDA process—one that no thermography company with an FDA 510k has successfully completed to date.
Security Risks: One of our IAMT Thermographers who attended a presentation reported that the company attempted to install their software on her computer and integrate it with her existing camera system. Given the software’s rudimentary nature and the international origin of the company, we caution you that this poses significant security and privacy risks.
No company can legally make claims of AI interpretation or breast cancer diagnosis. It is not included in their FDA 510k clearance. And when they do, they are at risk of being investigated by the FDA. When (not if) this happens, Thermographers using this technology will risk losing their ability to do business.
Our Recommendation: If you are contacted by an entity claiming AI capabilities, we urge you to exercise extreme caution and please report any interactions to the IAMT so we can continue to monitor and address this issue.
Thank you for your attention and commitment to maintaining the integrity and safety of our profession.
Sincerely,
Your IAMT Board of Directors
