Sonus Pharmaceuticals has settled a class action suit brought against it in a California Superior Court. The litigation, filed in San Diego, claimed that the company did not communicate clearly about the status of the Food and Drug Administration’s
Sonus Pharmaceuticals has settled a class action suit brought against it in a California Superior Court. The litigation, filed in San Diego, claimed that the company did not communicate clearly about the status of the Food and Drug Administrations clearance of EchoGen, the companys ultrasound contrast agent. Although Bothell, WA-based Sonus believes that the complaint was without merit, it chose to settle rather than engage in the litigation. Terms of the settlement were not disclosed, although Sonus did state that the terms were not monetary.
On the EchoGen front, at the end of September Sonus filed a complete response to conditions outlined in the FDAs approvable letter, which the company received in April (SCAN 4/28/99). Sonus believes that it has provided sufficient answer to the agencys letter, and continues to wait for its response, according to Greg Sessler, CFO.
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.