ACR outlines key changes in the new BI-RADS guidelines
After more than a decade without a major update, the American College of Radiology (ACR) has released BI-RADS Version 2025, a comprehensive revision that reflects sweeping changes in breast imaging technology, reporting standards and patient communication.
The ACR announced the release Dec. 1 during the Radiological Society of North America (RSNA) 2025 annual meeting. Radiology Business spoke with Dana Smetherman, MD, chief executive officer of the ACR and a longtime breast imager, about the update. She said it has been eagerly anticipated by the breast imaging community.
“I spent over 30 years as a breast radiologist, and so we are so excited,” she said. “It's actually been since 2013 that the last BI-RADS came out. That was the fifth edition. Now we're just calling this version 2025.”
Since the last update, breast imaging has evolved rapidly, prompting the need for sections covering new technologies and guidance.
“There has been so much new technology that's come around,” Smetherman explained. “Digital breast tomosynthesis was just starting out when the last version of BI-RADS came out. So we've expanded all the terminology for that.”
The new edition also added information on synthetic 2D mammography created from 3D mammography exams, and contrast-enhanced mammography. Neither technology was widely available, or not yet FDA approved, at the time of the last update. The scope of the new BI-RADS reflects those and many other changes.
“The old version was shorter. This one is over 900 pages and has over 900 images,” Smetherman said. “So it's going to be a tremendous resource and we're really excited about it.”
Among the biggest takeaways, Smetherman emphasized practical updates designed to help radiologists in daily practice.
“So, I think number one, we've expanded a lot of things,” she said. “I think it's going to be an even more helpful resource to people in practice. One key area is contrast-enhanced mammography and what the descriptors are going to be for [contrast-enhanced mammography] that people have been waiting for as they've employed these new technologies."
The update also includes changes aimed at harmonizing language with federal regulations.
“We're not calling the breast tissue descriptors 'breast composition,' we're calling it 'density,' which harmonizes with what the Mammography Quality Standards Act (MQSA), the revision that came out to make sure that that wording is not confusing for people.” Smetherman said. The new BI-RADS also include example form letters to inform patients about their breast density that align with updated FDA MQSA terminology.
She said several long-standing “pain points” were addressed, including clarification around BI-RADS category 0 recalls.
“Category zero is used when a patient needs something additional, but it's really just to get their old studies from another place for comparison,” Smetherman said. “But the wording was 'additional imaging evaluation' and now people will be able to say, no we just want to get previous studies.”
She noted that this new language is important not only for clinicians, but also for patients and referring physicians.
“I think it could be confusing for patients if they read the reports,” Smetherman said. “It could be confusing for the ordering physicians who think that the patient needs to come back.”
The growing dominance of digital breast tomosynthesis also influenced the update.
“So, tomosynthesis was really, really in its infancy,” she said. “I think it was only FDA approved in 2011, so in 2013, it really was just starting to be used and now it's much more in common practice.”
The guidelines also address synthetic 2D views generated from tomosynthesis data, which were not widely used a decade ago.
Breast density reporting and patient notification laws were another focus area.
“The awareness of the fact that breast density both makes it more difficult to identify cancers, but that women who have denser breast tissue are actually at an increased risk for breast cancer,” Smetherman said. She added that the updated BI-RADS aligns its nomenclature with the most recent MQSA revisions “just to try to remove any confusion for patients now that they have access to their reports as well.”
Finally, BI-RADS Version 2025 reflects a shift toward digital access. In the past, she said the document was primarily a print version that you could also get a digital version of, but now it is designed as a digital document, and the print run of hard copy books is limited.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]