U.S. Surgical allowed to market ABBI
The Food and Drug Administration has notified U.S. Surgical thatit will allow the Norwalk, CT, company to continue to market itsAdvanced Breast Biopsy Instrumentation (ABBI) device under theproduct's existing 510(k) application. The FDA issued a
The Food and Drug Administration has notified U.S. Surgical that
it will allow the Norwalk, CT, company to continue to market its
Advanced Breast Biopsy Instrumentation (ABBI) device under the
product's existing 510(k) application. The FDA issued a warning
letter to U.S. Surgical last month, claiming that ABBI's 510(k)
application did not include an indication for breast biopsy (SCAN
6/19/96). U.S. Surgical denied the FDA's claims. The two sides
are in negotiations to resolve any remaining issues related to
ABBI advertising and labeling, according to the company.
Study Shows No Impact of Hormone Therapy on PET/CT with 18F-Piflufolastat in PCa Imaging
May 7th 2025For patients with recurrent or metastatic prostate cancer, new research findings showed no significant difference in the sensitivity of 18F-piflufolastat PET/CT between patients on concurrent hormone therapy and those without hormone therapy.
