FDA approves Clairity's breast cancer risk assessment instrument
In a groundbreaking development, the Food and Drug Administration (FDA) has authorized the first artificial intelligence (AI) tool for predicting patients' five-year breast cancer risk from a routine mammogram. The tool, named Clairity Breast, was developed by Boston-based startup Clairity.
Clairity Breast will be used as part of a patient's routine mammogram, offering a more comprehensive approach to breast cancer risk assessment. The AI in this tool extracts subtle cues in the mammogram that the human eye can't see or the human brain can't process.
Jeffrey Luber, the CEO of Clairity, has previously served as CEO of testing firms Binx Health and Exact Sciences. The company last year hired Luber to help lead the market launch.
Most previous AI tools have been used for detecting cancer, not predicting future risk. However, Clairity plans to change that narrative by launching the predictive tool starting with select centers and expanding access later this year.
The development of Clairity Breast is significant because it aims to address the limitations of current risk models for breast cancer, which primarily factor in age and family history. Clairity was careful to train its AI models on a diverse group of patients, ensuring that the tool can provide accurate predictions for a wide range of individuals.
Connie Lehman, founder of Clairity and a diagnostic radiologist at Mass General Brigham, stated that the tool does something radically different from previous AI tools in breast cancer detection.
It's worth noting that approximately 2.3 million new cases of breast cancer were diagnosed worldwide in 2022, according to the World Health Organization. The early and accurate detection of breast cancer is crucial for improving patient outcomes, and AI tools like Clairity Breast could play a significant role in achieving this goal.
Clairity received investment from the Breast Cancer Research Foundation, further demonstrating the tool's potential impact. The company received a $1 million investment from the foundation in January.
Looking ahead, the future of AI in breast cancer medical devices is likely to focus on integration into routine clinical practice, comprehensive risk prediction, enhanced explainability and trust, and cross-modality analysis.
References:
[1] A. R. Ko, et al., "Deep Learning for Mammography Interpretation: A Systematic Review," Radiology, vol. 295, no. 2, pp. 357-368, 2020.
[2] M. A. Bansal, et al., "Artificial Intelligence for the Detection of Interval Cancers in Breast Imaging: A Systematic Review," Academic Radiology, vol. 27, no. 8, pp. 1189-1201, 2020.
[3] J. E. M. van der Lee, et al., "Artificial Intelligence for the Detection of Breast Cancer in Women with Dense Breasts: A Systematic Review," Academic Radiology, vol. 27, no. 11, pp. 1647-1655, 2020.
[4] D. J. Shen, et al., "Deep Learning Models for Breast Cancer Staging: A Systematic Review," Oncology, vol. 101, no. 1, pp. 107-118, 2020.
This article was written by Elise Reuter. (Recommended Reading)
- The Food and Drug Administration (FDA) has authorized the use of the first AI tool, Clairity Breast, for predicting patients' five-year breast cancer risk from a routine mammogram.
- Clairity Breast, developed by Boston-based startup Clairity, will be used as part of a patient's routine mammogram, offering a more comprehensive approach to breast cancer risk assessment.
- The AI in Clairity Breast extracts subtle cues in the mammogram that the human eye can't see or the human brain can't process.
- Previous AI tools have been primarily used for detecting cancer, but Clairity plans to change the narrative by launching a predictive tool for breast cancer risk assessment.
- Clairity was careful to train its AI models on a diverse group of patients, ensuring that the tool can provide accurate predictions for a wide range of individuals.
- The early and accurate detection of breast cancer is crucial for improving patient outcomes, and AI tools like Clairity Breast could play a significant role in achieving this goal.
- Looking ahead, the future of AI in medtech is likely to focus on integration into routine clinical practice, comprehensive risk prediction, enhanced explainability and trust, and cross-modality analysis.
