2 February 2021; Company Announcement – FDA Breast Density 2 FEB 2021 – Acrobat pdf 109k


  • First Artificial Intelligence (AI) algorithm developed by PME 
  • Developed using PME’s unique end-to-end AI Accelerator solution 
  • FDA clearance is in addition to previously received CE (Europe) and TGA (Australia)
  • Paves the way for commercialization in North America, Europe and Australia 
  • Opens up further research collabouration opportunities

Leading health imaging company Pro Medicus Limited [ASX: PME] today announced that it has received FDA clearance for its Breast Density AI algorithm. This is in addition to previously receiving CE clearance (Europe) and TGA clearance (Australia) paving the way for the company to market the algorithm across all three jurisdictions.

The Breast Density algorithm is intended for use with compatible full field digital and digital breast tomosynthesis systems. It assesses breast density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. 

“We developed this algorithm using our own AI Accelerator platform which enabled us to significantly speed up every stage of the process from concept to FDA approval,” said Dr Sam Hupert, Pro Medicus CEO. “This not only provides us with a fast-track mechanism to develop our own algorithms in the future, it paves the way for further collaborations with the growing number of our research oriented clients.”