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HomeDigital HealthDigital TherapeuticsTherapixel Receives FDA Clearance for AI-Based Breast Cancer Screening Software MammoScreen® on...

Therapixel Receives FDA Clearance for AI-Based Breast Cancer Screening Software MammoScreen® on 3D Mammography

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Therapixel mammoscreen

Therapixel has announced it has received a second 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its explainable and actionable Artificial Intelligence (A.I.) based software assisting Radiologists in breast cancer screening, MammoScreen. This new 510(k) (K211541) expands the use of Mammoscreen® to Digital Breast Tomosynthesis (or 3D Mammography).

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Breast cancer is the second cause of cancer death worldwide. In the United-States, 1 in 8 women will develop breast cancer during their lifetime. Early detection is the key to successful treatment. Therapixel is a French company that specializes in the design and commercialization of AI-powered medical imaging software to deliver relevant information at the right time to healthcare professionals. 

This FDA clearance, received after submitting results from a multi-reader study conducted earlier this year, makes Mammoscreen® immediately available to the entire U.S. mammography market. Compared to radiologists alone, study findings revealed improved readers’ performance in screening for lesions when paired with the solution. Additionally, the study showed significant time saving when using MammoScreen®.


MammoScreen Score™

  • The MammoScreen Score™ calibrates so providers can have high confidence in cases with high or low scores. 
  • Therapixel’s solution provides quick and reliable confirmation of what you suspect and what needs more attention. 
  • Mammograms with a score from 1 to 4 are very unlikely to contain cancers. 
    • Cases with a score from 7 to 10 are very likely to be malignant.
    • Scores of 5 or 6, the A.I. software calls attention to issues where the radiologist will need to look closer to conclude.


According to the MammoScreen® website, its solution can help catch cancers designating areas to look at that might have been missed. At first, the software displays only questionable findings. For most mammograms with a low likelihood of cancer (up to 75% of the cases), providers won’t see any marks on the interface, which may help care teams become more agile.

With so much information and technologies out there, it is not easy to build interventions or technologies easily adapted and effectively used to change lives. MammoScreen® AI-based software works alongside your viewer to provide an expert, confirming look at a mammogram, without disrupting your workflow. The product/software has been designed to enhance workflow, with side-by-side monitor interface• Dedicated monitor provides at-a-glance decision-making support. The solution synchronizes with care teams work list, with no additional clicks.

Receiving this second FDA clearance for MammoScreen® is a major milestone for Therapixel. Thanks to a deep and fruitful collaboration with radiologists, we have, over the last 18 months, turned the 2017 DREAM challenge winning 2D algorithm to a powerful FDA-cleared product for both 2D and 3D mammography. MammoScreen® can now assist all radiologists in their day-to-day-work whichever modality they are using.

Pierre Fillard, Ph.D., Founder and Chief Scientific Officer of Therapixel

About Therapixel

Therapixel is a French company specialized in the design and commercialization of AI-powered medical imaging software, to deliver pertinent information at the right time to healthcare professionals. Winner of the Digital Mammography DREAM Challenge in 2017, the global competition on breast cancer detection with AI, Therapixel has developed MammoScreen®. This software helps with the interpretation of screening 2D and 3D mammograms. With MammoScreen®, even experienced radiologists can improve their performance, feel more confident in their judgment, and reassure women quicker.

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Logan Harper
Logan Harper
With an M.S. in Organizational Leadership, my background lies within the healthcare operations and sales sector, specifically within the digital health/ digital therapeutics arena. I have a proven track record of developing and implementing effective sales strategies, establishing organizational partnerships, and creating effective product/service/sales training programs and collateral.

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