FDA eases rules on digital mammography devices

Nov 3, 2010

The U.S. Food and Drug Administration has downgraded the classification of full-field digital mammography devices from high risk to medium risk, making it easier for companies to bring the technology to market, the agency announced today.

Click here to read the rest of the article.

Latest in Breast
Hologic Rsna 2019 400
Hologic highlights results from a study on AI-powered mammography
December 16, 2025
Doctor Patient Consult Tablet
Study highlights risk-based breast cancer screening; ACR responds
December 12, 2025
Images depict a 50-year-old woman with a lesion detected during screening ultrasound. (A) Transverse and (B) longitudinal images reveal a 0.5-cm hypoechoic lesion (arrow) in the left breast. (C) Transverse color Doppler ultrasound image does not show an increase in vascularity. Two readers classified the lesion as a mass, whereas two others categorized it as a nonmass lesion, leading to its designation as a controversial nonmass lesion. Ultrasound-guided core needle biopsy and subsequent pathologic examination confirmed a nonproliferative breast change.
Radiologists can designate nonmass lesions on breast ultrasound
December 9, 2025
Acr Logo 2023 400
ACR talks BI-RADS version 2025 with AuntMinnie
December 8, 2025
Related Stories
2010 09 07 11 17 05 930 Durictalk Thumb
Ultrasound
Whole-breast ultrasound tomography shows promise
2010 08 19 12 35 41 749 Destounis thumb 08 10 Sm
Breast
Breast CAD helps find lobular carcinoma in situ lesions
2009 06 23 14 37 33 976 Second Opinion Am
Breast
The breast screening hullabaloo: Where are we today?
2010 08 04 12 49 39 380 Dave Figure 1 E Thumb
Ultrasound
Subharmonic breast ultrasound technique shows promise
More in Breast
Hologic highlights results from a study on AI-powered mammography
By AuntMinnie.com staff writers
Hologic's Genius AI Detection flagged 32% of false-negative cases and nearly 90% of identified cancers.
December 16, 2025
Hologic Rsna 2019 400
Study highlights risk-based breast cancer screening; ACR responds
By Amerigo Allegretto
A study showing the potential benefits of risk-based breast cancer screening has drawn criticism from the ACR.
December 12, 2025
Doctor Patient Consult Tablet
Radiologists can designate nonmass lesions on breast ultrasound
By Amerigo Allegretto
Breast radiologists achieved moderate to substantial interreader agreement for classifying nonmass lesions on ultrasound.
December 9, 2025
Images depict a 50-year-old woman with a lesion detected during screening ultrasound. (A) Transverse and (B) longitudinal images reveal a 0.5-cm hypoechoic lesion (arrow) in the left breast. (C) Transverse color Doppler ultrasound image does not show an increase in vascularity. Two readers classified the lesion as a mass, whereas two others categorized it as a nonmass lesion, leading to its designation as a controversial nonmass lesion. Ultrasound-guided core needle biopsy and subsequent pathologic examination confirmed a nonproliferative breast change.
ACR talks BI-RADS version 2025 with AuntMinnie
By Amerigo Allegretto
ACR members discussed the need to release the latest version of BI-RADS and what changes breast radiologists can expect.
December 8, 2025
Acr Logo 2023 400
DeepHealth unveils DeepHealth Breast Suite
By AuntMinnie.com staff writers
DeepHealth has unveiled the DeepHealth Breast Suite, a collection of AI-powered applications for breast cancer screening and detection.
December 2, 2025
Artificial Intelligence Ai Binary Code
ACR releases updated BI-RADS manual
By AuntMinnie.com staff writers
The ACR has released its Breast Imaging Reporting and Data System (BI-RADS) v2025 Manual.
December 1, 2025
Acr Logo 2023 400
Ikonopedia adds CEM to its offerings
By AuntMinnie.com staff writers
Ikonopedia has added contrast-enhanced mammography (CEM) to its integrated reporting platform.
November 30, 2025
Breast Cancer2 400
FDA signs off on GE HealthCare’s 3D mammography software
By AuntMinnie.com staff writers
GE HealthCare has received premarket approval from the U.S. Food and Drug Administration (FDA) for Pristina Recon DL.
November 26, 2025
Ge
Radiologist performance, patient factors tied to interval cancer risk
By Amerigo Allegretto
Breast density, family history of breast cancer, and inadequate radiologist performance influence interval breast cancer risk.
November 26, 2025
2025 11 25 Radiology Mammograms Interval Cancers Thumbnail
House members reintroduce Find It Early Act
By Amerigo Allegretto
Members of the U.S. House of Representatives have reintroduced the Find It Early Act to remove barriers to breast imaging.
November 21, 2025
Capitol Hill Government
Breast Cancer Canada releases 2025 Progress Report
By AuntMinnie.com staff writers
Breast Cancer Canada has released its 2025 Annual Progress Report.
November 20, 2025
Canada Flag 400
AI-driven workflow delivers equitable breast cancer care
By Amerigo Allegretto
An AI-powered workflow increased cancer detection while not adding to disparities in race and breast density.
November 19, 2025
Doctors Working Monitor Consult 400 (1)
Page 1 of 576
Next Page