Designation of FDA breakthrough device granted for the AI mammography analysis tool

A new technology that exploits AI to analyze mammograms. Consequently, improve the precision of the personalized risk prediction of five years of a woman has received the designation of breakthrough devices from the Food and Drug Administration (FDA). Consequently, Developed by researchers from the Washington University School of Medicine by St. Similarly, Louis, the software has been authorized to Prognosia Inc., a Washu startup.

The system analyzes mammograms to produce a risk score that believes that a woman is developing breast cancer over. Furthermore, the next five years. Furthermore, The technology is compatible with the two types of mammography imaging available: the four 2D searches of the breast produced by the digital mammography in full field. In addition, the 3D synthetic view of the breast produced by the tomosynthesis of the digital designation fda breakthrough device granted breast. However, Above all. For example, the system produces an absolute risk of five years which makes it possible to compare the risk of a woman to an average risk based on national rates of incidence of breast cancer. Moreover, This provides a significant estimate that is aligned with national American risk reduction directives. Nevertheless, so that clinicians know what measures then take if the risk of a woman is high.

The designation of FDA breakthrough device provides an accelerated examination process for complete market approval in order to give patients. Furthermore, clinicians accelerated access to new medical devices. Nevertheless, The products that receive the designation have already undergone rigorous tests. Therefore, have shown an excellent promise in their potential for improving the treatment or diagnosis of debilitating or potentially fatal conditions.

The software, called Prognosia Breast, was developed by Graham A. Moreover, Colditz. Similarly, MD, Drph, professor of Niess-Gain designation fda breakthrough device granted surgery at Washu Medicine and associate director of prevention and control at the Cancer Center, based at Barnes-Jewish hospital and Washu medicine; And Shu (Joy) Jiang, PHD, associate professor of surgery in the public health science division in the Washu Medicine surgery department. Meanwhile, Colditz. For example, Jiang co -founded Prognosia in 2024 in collaboration with Washu’s Office of Technology Management (OTM) and Biogenerator Ventures, the latter, whose financial support and expertise in commercial strategy of the entrepreneur in residence David Smoller, PHD.

The software is a pre-formulated automatic learning system that analyzes mammography images. However, provides an estimate of the probability that a patient must develop breast cancer over the next five years, based solely on the images and the age of a woman. Similarly, According to the developers, Prognosia breast estimates the risk of a person of a person to develop breast cancer 2.2 times more precisely than designation fda breakthrough device granted the standard method. which is based on questionnaires which take into account factors such as age, race and family history. The system was formed on past mammograms of tens of thousands of people who have been screening for breast. cancer by the Cancer of Siteman. Some of them continued to develop cancer. teacher in the system what to seek in the first stages of tumor development. Such early signs of illness cannot be perceived even by a well -formed human eye.

We are delighted with the potential of this technology to improve risk forecast. breast cancer prevention, it doesn’t matter where a woman is detected. The long -term objective is to make this technology available to any woman who undergoes mammography of screening all. over the world. Regardless of the type of imagery they receive. our data shows the potential of the software to identify women at risk increased designation fda breakthrough device granted to develop breast cancer over the next five years, which offers them opportunities to take targeted measures to reduce this risk. “”

Graham A. Colditz. MD, Drph, Niess-Gain surgery teacher at Washu Medicine

The new device could have a significant impact on risk prediction because the infrastructure is already in place to start immediately using software mammography anywhere is provided. In addition, many women already receive regular mammograms. According to 2023 survey data for centers for disease control. prevention, more than 75% of women aged 50 to 74 have said they had received a mammography in the past two years.

Even with generalized screening. around 34% of patients with breast cancer in the United States are diagnosed at subsequent stages of the disease. According to investigators. being able to assess the risk up to five years before the start of cancer is likely to improve early designation fda breakthrough device granted detection, reducing the number of cancers at an advanced stadium diagnosed. Early detection has been shown to make treatment more effective and reduces death cancer deaths.

“The reception of a revolutionary device designation is a powerful validation of the extraordinary dedication. vision of this research team to improve the diagnosis and care of breast cancer,” said Doug E. Frantz, PhD, Vice-Chancellor of innovation and marketing at Washu. “It takes years of concerted efforts to produce software that could quickly be integrated into the workflow of any mammography center. considerably improving the clinical value of routine mammograms, regardless of where they are provided. This is an excellent example of the vital role of entrepreneurship. marketing in Washu in the transformation of advanced research into real technologies that improve patient care. »»

The device produces a five -year risk score which is intended to complete. and not to replace, the analysis provided designation fda breakthrough device granted by radiologists, which will continue to examine the mammography after the standard protocols. According to the American Society of Clinical Oncology. the US Preventive Services Task Force, a risk score of five years of 3% or more is considered high. According to the guidelines of these organizations. women with high scores must be referred to specialists who can advise them more on their additional screening and prevention strategies.

In the United States, around one in eight will receive a diagnosis of breast cancer during their lifetime. Those who are at high risk of this cancer have the possibility of receiving more frequent screening – which may include other types of imaging. such as MRI – and, in some cases, can choose to take a type of chemotherapy called Tamoxifen or endocrine treatment as a preventive treatment. With such options available. the identification of high -risk women is significant so that designation fda breakthrough device granted they have access to specialists who can guide them to make these important choices.

The developers provide a clinical trial at the siteman Cancer Center which will apply the risk score of the. breast of Prognosia in combination with the screening protocols of standard mammography. Standard screening protocols include the review of mammography and breast density measurements already provided to all patients. Individuals deemed at high risk will be referred to the health specialists of the siteman. who focus on helping individuals to navigate in the options they have to manage a high risk of breast cancer.

“Despite the sophistication of today’s breast imaging. its general use to identify existing tumors, today’s risk prediction for breast cancer is still based on the questionnaire and not very good to estimate future risks,” said Jiang. “Our work focused on filling this need for better methods. Going to the image -based risk prediction designation fda breakthrough device granted – that our studies have shown are much more precise – has. the potential to be revolutionary for patient care. »»

The current designation of the FDA applies to the analysis of the software of mammography images taken at one moment. In the future. researchers plan to update the breast of Prognosia to analyze several years of mammography of the same individual, which could still improve the precision of prediction.