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.
Could Virtual Non-Contrast Images from Photon-Counting CT Reduce Radiation Dosing with CCTA?
March 28th 2024Emerging research on coronary artery calcium scoring for the assessment of coronary artery disease (CAD) suggests the use of virtual non-contrast images from photon-counting CT may lead to a nearly 20 percent reduction in radiation dosing.
FDA Clears CT-Based AI Tools for PE Detection and Stroke Severity Assessment
March 26th 2024The artificial intelligence (AI) modalities CINA-iPE and CINA-ASPECTS may facilitate improved detection of incidental pulmonary embolism and stroke evaluation, respectively, based on computed tomography (CT) scans.