PARIS, Nov. 28, 2021 /PRNewswire/ -- 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).
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
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
"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.
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
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 specialized in the design and
commercialization of AI-powered medical imaging software, with the
goal of delivering 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®, a
software that 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. Find more
View original content to download