Therapixel, a company leading the use of AI-based products for women’s health, announces it has received a second 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MammoScreen®, the 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).
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This FDA clearance, received after submitting results from a multi-reader study conducted earlier this year, makes Mammoscreen 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. Additionally, the study showed significant time saving when using MammoScreen®.
MammoScreen® automatically detects and characterizes suspicious soft tissue lesions and calcifications in mammography and tomosynthesis images while assessing their likelihood of malignancy. The results are summarized by the MammoScreen Score™ that characterizes suspiciousness of each lesion scored on a scale of 1-10, with 1, being least likely to reveal malignancy and 10 most likely.
“Receiving this second FDA clearance for MammoScreen® is a major milestone for Therapixel,” said Pierre Fillard, Ph.D., Founder and Chief Scientific Officer of 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 optimized 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.