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 Study Assesses Long-Term Outcomes of PSMA PET Use in PCa Recurrence Cases
October 24th 2024For patients with biochemical recurrence of prostate cancer, PSMA PET imaging may facilitate a 12.8 percent lower incidence of prostate cancer mortality in contrast to the combination of CT and bone scan, according to long-term outcome estimates from a new decision-analytic modeling study.
Can Diffusion MRI Predict Patient Response to Neoadjuvant Chemotherapy for Breast Cancer?
October 23rd 2024A model emphasizing time-dependent diffusion MRI was 15 percent more effective than apparent diffusion coefficient (ADC) measurements at predicting pathologic complete response to neoadjuvant chemotherapy for women with breast cancer, according to new research.