SYNOPSIS:

• New 510(k) clearance expands the use of MammoScreen from 2D to 3D mammography, opening up the entire breast cancer screening market.
• MammoScreen automatically detects and characterizes suspicious soft tissue lesions and calcifications in mammography and tomosynthesis images while assessing their likelihood of malignancy.
• 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 receives FDA 510(k) Clearance for use of its AI-based Breast Cancer Screening Software MammoScreen on Digital Breast Tomosynthesis

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 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. 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.”

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.

What Is Breast Cancer?

Breast cancer is a disease in which cells in the breast grow out of control. There are different kinds of breast cancer. The kind of breast cancer depends on which cells in the breast turn into cancer.

Breast cancer can begin in different parts of the breast. A breast is made up of three main parts: lobules, ducts, and connective tissue. The lobules are the glands that produce milk. The ducts are tubes that carry milk to the nipple. The connective tissue (which consists of fibrous and fatty tissue) surrounds and holds everything together. Most breast cancers begin in the ducts or lobules.

Breast cancer can spread outside the breast through blood vessels and lymph vessels. When breast cancer spreads to other parts of the body, it is said to have metastasized.

Kinds of Breast Cancer

The most common kinds of breast cancer are—

• Invasive ductal carcinoma. The cancer cells begin in the ducts and then grow outside the ducts into other parts of the breast tissue. Invasive cancer cells can also spread, or metastasize, to other parts of the body.
• Invasive lobular carcinoma. Cancer cells begin in the lobules and then spread from the lobules to the breast tissues that are close by. These invasive cancer cells can also spread to other parts of the body.

What Is Breast Cancer Screening?

Breast cancer screening external icon means checking a woman’s breasts for cancer before there are signs or symptoms of the disease. All women need to be informed by their health care provider about the best screening options for them. When you are told about the benefits and risks of screening and decide with your health care provider whether screening is right for you—and if so, when to have it—this is called informed and shared decision-making.

Although breast cancer screening cannot prevent breast cancer, it can help find breast cancer early, when it is easier to treat. Talk to your doctor about which breast cancer screening tests are right for you, and when you should have them.

What Is a Mammogram?

A mammogram is an X-ray picture of the breast. Doctors use a mammogram to look for early signs of breast cancer. Regular mammograms are the best tests doctors have to find breast cancer early, sometimes up to three years before it can be felt.

MammoScreen Score:

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

About Therapixel:

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.

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