Carestream gets FDA nod for CR mammo

Lisa Fratt | | Health Exec | EMR/EHR
Carestream Health has received an approval letter from the FDA for its computed radiography (CR) system for mammography.

The company said its Carestream DirectView CR Mammography Feature enables mammography images to be captured digitally while utilizing a healthcare provider’s existing mammography x-ray unit and workflow processes. It is intended for use in the same clinical applications as traditional screen-film based mammography systems.

This optional mammography feature is available when purchasing a new Carestream DirectView Elite, Classic or CR 975 System, or as a retrofit to installed Elite, Classic or CR 850/950/975 systems.

With this feature, Carestream’s CR systems can be used for both general radiography and mammography exams. In addition, the optional Carestream DirectView CR Mammography Total Quality Tool is available to streamline objective mammography image testing and QC measurements, according to the Rochester, N.Y.-based company

Carestream has sold its CR mammography feature in Europe, Greater Asia, Japan and Latin America since 2005 and installed systems with its mammography capability in clinics, breast imaging centers and hospitals. In addition, Carestream has sold the system in Canada since 2007 after it received regulatory approval from Health Canada.

Once the FDA approves the final product labeling, Carestream said it will begin distribution in the U.S.


Lisa Fratt

Related Content

Private equity-backed cardiology group puts cloud-based technology in hands of its cardiologists
AI helps cardiologists deliver personalized healthcare—but there is still plenty of work to do
Indiana hospitals reduce nuisance alerts by 77% with medication decision support software
Leveraging machine learning to rapidly create clinical AI algorithms
How medication reconciliation data consolidation in the EHR enables better patient care
How are the best in KLAS Health IT vendor rankings created?

Around the web

Cardiovascular Business
Payment cuts and beyond: Key takeaways for cardiologists from the 2025 Medicare Physician Fee Schedule

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

AI in Healthcare
A modest proposal to rally AI regulators around a simple game plan

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

Cardiovascular Business
FDA commissioner urges clinicians to join fight against medical misinformation

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

Design by Adaptive Theme
Trimed Popup
Trimed Popup