FDA approves AI-based breast cancer screening software MammoScreen®
pharmafile | November 29, 2021 | News story | Sales and Marketing |
The FDA has approved MammoScreen®, Therapixel’s explainable and actionable Artificial Intelligence (AI) based software assisting Radiologists in breast cancer screening. This new 510(k) (K211541) expands the use of MammoScreen® to Digital Breast Tomosynthesis (or 3D Mammography).
This FDA clearance means that MammoScreen will become immediately available to the entire US mammography market. Study findings revealed improvement in readers’ performance in screening for lesions when paired with MammoScreen® compared to radiologists alone.
MammoScreen® automatically detects and characterises suspicious soft tissue lesions and calcifications in mammography and tomosynthesis images, while assessing their likelihood of malignancy. The results are then summarised by the MammoScreen Score™ that characterises suspicion of each lesion scored on a scale of 1-10, with one meaning least likely to reveal malignancy, and ten most likely.
Breast cancer is the second cause of cancer death worldwide, and the most common cancer in the UK population. In the US, one in eight women will develop breast cancer during their lifetime.
Pierre Fillard, PhD, Founder and Chief Scientific Officer of Therapixel, commented: “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.
“MammoScreen® now covers both the gold standard 2D mammography and the state-of-the-art 3D tomosynthesis modalities. This provides quick and reliable confirmation of Radiologists’ suspicions as they read,” said Matthieu Leclerc-Chalvet, Therapixel CEO.
“Tomosynthesis is known as time consuming because of the large number of images to review. MammoScreen® allows a more optimised and certain assessment by Radiologists and a speedier reassurance of women having breast cancer screening exams, resulting in a more efficient workflow and reduced costs for the healthcare system. Thanks to this new FDA clearance, we expect significant growth in the US market and we look forward to installing MammoScreen® in additional radiology departments and institutions across the U.S. so that imaging professionals and women can benefit from its use.”