Therapixel announces two new FDA clearances for its most advanced breast cancer screening AI solution 

Therapixel, maker of MammoScreen, has announced that it has received two new FDA 510(k) clearances, resulting in the release of its most comprehensive breast cancer screening AI. With a set of powerful new features, MammoScreen goes beyond suspicious lesion detection and characterisation and incorporates AI into all areas of the breast imaging workflow.  

The new version of MammoScreen maintains the consistent and actionable MammoScreen Score while increasing the radiologist’s sensitivity and specificity. This newly cleared full AI-suite provides the following powerful new features which will considerably improve radiologists’ workflow:  

• Worklist Management with a complexity index to help organise the day, leading to a 40% reduction in radiologist’s fatigue.  

• Case Pre-Check provides patient health history, helping to avoid interruptions and wasted time locating information. 

• Screening Assessment with MammoScreen’s unrivalled use of priors, helping save up to 35% of reading time.  

• Breast Density assessment to help radiologists with another area of concern they are required to report.  

• Pre-reporting which automatically generates the screening evaluation report for radiologists’ validation, saving even more time on the tedious reporting requirements.  

These new features, now available for clinical use, will help radiologists read faster and more confidently, thus delivering results to women in a more timely and assured manner. The new release of MammoScreen helps make the entire organisation better. 

“Therapixel has consistently empowered radiologists to excel, ensuring women receive reassurance faster and with greater confidence,” said Matthieu Leclerc-Chalvet, CEO of Therapixel. “These major clearances and releases elevate MammoScreen to a comprehensive suite, assisting radiologists at every step of the breast cancer screening workflow and providing a service unmatched in the industry. With these new features, radiologists can double their reading time savings compared to the previous version. Radiologists will appreciate the reduced fatigue, administrators the improved efficiency and care consistency, and the IT team the seamless one-time installation. We’re proud to launch this new version of MammoScreen, once again delivering unparalleled value to radiologists and patients.”