The iBreastExam, a handheld device cleared by the FDA, reportedly enhances routine clinical breast examinations.
In a new distribution agreement with the manufacturer UE LifeSciences, Siemens Healthineers plans to launch the iBreastExam, a handheld cancer screening modality that helps clinicians identify non-palpable breast lumps in a matter of minutes.
In addition to reportedly being a painless alternative to help alleviate patient anxiety about breast examinations, the iBreastExam may serve as an effective tool to facilitate early screening for breast cancer, a disease that is currently expected to claim the lives of approximately 43,250 women in the U.S. in 2022. The launch of the iBreastExam in the United States will begin this month, according to Siemens Healthineers.
“We’re committed to improving breast cancer-related outcomes by recognizing unmet needs in healthcare delivery, and UE LifeSciences’ iBreastExam clearly addresses a well-defined niche in primary care,” said Niral Patel, the vice president of X-ray products for Siemens Healthineers. “With iBreastExam, we’re making women’s health more equitable and inclusive for all populations.”
In a 2020 study published in JCO Global Oncology, researchers said the iBreastExam and clinical breast exams can be used synergistically as triage tools to “significantly reduce the numbers of patients who need additional diagnostic imaging in resource-limited areas.” The iBreastExam had a specificity of 80.3 percent and a negative predictive value of 94 percent, according to the study.
Siemens Healthineers added that the iBreastExam provides automated digital documentation that can be linked to a patient’s electronic health record.
“An objective, quick, and painless documentation of routine breast exams informs and empowers care providers and women, especially those younger than 40, with dense breasts, or with family history,” noted Brian Englander, M.D., the chairman of the Department of Radiology at Pennsylvania Hospital.