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- Mammography
Biopsys resolves FDA labeling issue
Mammography biopsy developer Biopsys of Irvine, CA, announcedlast week that the Food and Drug Administration has accepted itsplan to resolve the agency's concerns about labeling of the company'sMammotome biopsy device. The FDA was concerned about
Mammography biopsy developer Biopsys of Irvine, CA, announcedlast week that the Food and Drug Administration has accepted itsplan to resolve the agency's concerns about labeling of the company'sMammotome biopsy device. The FDA was concerned about marketingmaterials for Mammotome that suggested that the device could beused for therapeutic applications, such as complete excision ofsuspicious breast lesions (SCAN 2/19/97).
As part of the resolution, Biopsys on Feb. 12 submitted a new510(k) application for Mammotome indicating that the product isspecifically intended for breast biopsy for diagnostic purposes.Biopsys will be able to continue selling Mammotome while the FDAreviews the new 510(k).
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.
