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- Molecular Imaging
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- Mammography
FDA clears new Biopsys 510(k) request
The Food and Drug Administration this month granted premarket notification clearance to a new 510(k) application filed by Biopsys Medical of Irvine, CA, for its Mammotome breast biopsy device. Biopsys filed the new 510(k) application on Feb. 12 as part
The Food and Drug Administration this month granted premarket notification clearance to a new 510(k) application filed by Biopsys Medical of Irvine, CA, for its Mammotome breast biopsy device. Biopsys filed the new 510(k) application on Feb. 12 as part of an agreement with the FDA to resolve labeling issues regarding Mammotome (SCAN 3/5/97). The agency's move allows Biopsys to market Mammotome for diagnostic breast biopsy applications.
New CT Angiography Study Shows Impact of COVID-19 on Coronary Inflammation and Plaque
February 5th 2025Prior COVID-19 infection was associated with a 28 percent higher progression of total percent atheroma volume (PAV) annually and over a 5 percent higher incidence of high-risk plaque in patients with coronary artery lesions, according to CCTA findings from a new study.
