Addition Tracks FDA Premarket Clearance on Breast CBCT Imaging
Annapolis, MD, November 26, 2024 —RadSite™, a leading accreditation body promoting quality-based imaging practices, announced that it is adding Cone Beam Breast CT (CBBCT) imaging to its Medical Cone Beam CT (CBCT) Standards, v 1.3. Other specialty areas covered by the CBCT Standards include:
- Dental
- ENT
- Maxillofacial
- Musculoskeletal
- Chiropractic
- Orthopedics
- Podiatry
“RadSite’s Cone Beam CT Standards Committee meets on a regular basis to improve the Standards for its accreditation program,” notes Adam Powell, PhD, RadSite’s Standards Committee co-chair and president of Payer+Provider Syndicate. “Among other changes, RadSite implemented the Cone Beam Breast CT accreditation as an interim upgrade to the Standards. RadSite will complete a major upgrade to the Advanced Diagnostic Imaging Standards in the next year.”
“After 14 years of research and development dedicated to Koning CBBCT imaging, a substantial body of work has been published in more than 160 peer-reviewed papers. This research addresses the many features and functions of dedicated breast imaging using a designated Cone Beam CT system,” notes David Georges, president of Koning Americas. “Without this international work, CBBCT may not have been awarded the US Federal Drug Administration Premarket Approval. Not to mention, the American Medical Association’s issuance of the vignettes and CPT codes that apply to conventional CT and Cone Beam CT.”
“RadSite is pleased with the Standards Committee and Boards decision to add CBBCT as a specialty to the ADI Standards,” adds Garry Carneal, JD, MA, RadSite’s president and chief executive officer. “The U.S. Centers for Medicare and Medicaid Services (CMS) also was informed of this change as part of RadSite’s reporting requirements.”
“The adoption of the CBBCT specialty by RadSite, with the support of CMS, is an important step in the broader adoption of this type of imaging,” adds Georges. “There are many case scenarios that demonstrate the clinical efficacy of Cone Beam CT for breast imaging, such as reducing the reliance on compressional mammography and the need for call backs for additional views and retakes for poor positioning. CBBCT can also improve the patient’s experience and increase patient compliance.”
To learn more about RadSite’s CBCT Accreditation Programs, click here. To listen to several webinars on CBCT imaging trends and RadSite’s accreditation review process, visit RadSite’s YouTube page and navigate to the CBCT Imaging Playlist.
About RadSite™
Founded in 2005, RadSite promotes quality-based practices for imaging systems across the United States and its territories. RadSite is recognized by the U.S. Centers for Medicare and Medicaid Services as an official accreditation organization under the Medicare Improvements for Patients and Providers Act of 2008. RadSite is also recognized by over 300 payers and has accredited over 1,500 imaging suppliers. The agency’s programs help assess, track, and report imaging trends to enhance imaging procedures and outcomes. RadSite also offers educational programs, publishes issue briefs, and underwrites research on a complimentary basis to raise awareness of safety issues and to promote best practices. The organization is governed by an independent advisory board and committee system, which is open to a wide range of volunteers to ensure transparency and accountability.