FDA to hold digital mammography hearing
The Food and Drug Administration's radiological devices panel of the medical devices advisory committeewill be meeting on March 6 to discuss requirements for submissionsof digital mammography device approval applications. The meetingwill cover the FDA's
The Food and Drug Administration's radiological devices panel of the medical devices advisory committeewill be meeting on March 6 to discuss requirements for submissionsof digital mammography device approval applications. The meetingwill cover the FDA's proposal to regulate full-field-of-view digitalmammography products as class-three devices, a move that wouldrequire vendors to submit premarket approval applications (PMAs)to the FDA (SCAN 1/18/95).
The meeting will begin at 8 a.m. in Conference Room 20G inthe Corporate Building at the FDA's headquarters at 9200 CorporateBlvd., Rockville, MD. Industry comments before the meeting canbe directed to Dr. Steven C. Quay of Sonus Pharmaceuticals, whois serving as the industry representative on the radiologicaldevices panel. Dr. Quay can be reached at Sonus Pharmaceuticals,22026 20th Ave. SE, Suite 102, Bothell, WA 98021. His phone numberis 206/487-9500.
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.
Contrast-Enhanced Mammography and High-Concentration ICM Dosing: What a New Study Reveals
June 16th 2025New research showed a 96 to 97 percent sensitivity for contrast-enhanced mammography (CEM) with an increased iodine delivery rate facilitating robust contrast enhancement for women with aggressive breast cancer.
Mammography AI Platform for Five-Year Breast Cancer Risk Prediction Gets FDA De Novo Authorization
June 2nd 2025Through AI recognition of subtle patterns in breast tissue on screening mammograms, the Clairity Breast software reportedly provides validated risk scoring for predicting one’s five-year risk of breast cancer.
