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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.
FDA Clears New Features in AI-Powered Mammography Software Suite
October 11th 2024Therapixel’s MammoScreen suite has received 510(k) FDA clearances for a breast density assessment feature and updated software that includes automated pre-reporting, which reportedly expedites reporting of mammography findings.
