FDA to rule on MBI agent this month
The Food and Drug Administration has told ultrasound contrast developer Molecular Biosystems of San Diego that it expects to issue a final decision on ultrasound contrast regulation by July 28. The ruling should help clear up a regulatory morass that has
The Food and Drug Administration has told ultrasound contrast developer Molecular Biosystems of San Diego that it expects to issue a final decision on ultrasound contrast regulation by July 28. The ruling should help clear up a regulatory morass that has halted the review of most ultrasound contrast agents (SCAN 4/30/97).
The FDA in April suspended its regulatory review of MBI's Optison agent (formerly known as FS069) in response to citizen's petitions filed by competitors Bracco, Sonus Pharmaceuticals, and ImaRx Pharmaceutical and its partner Du Pont Merck. The FDA also froze its review of agents under development by those companies.
The petitioning companies charge that MBI has received preferential treatment from the FDA because Optison is being regulated by the agency's Center for Devices and Radiological Health, while their products are being reviewed by the Center for Drug Evaluation and Review.
In response to lawsuits filed by the three companies, the FDA was ordered by a U.S. District Court judge to review the merits of the citizen's petitions before proceeding with the review process. Late last month, MBI reported that the FDA has told the company that it expects to issue a final ruling on the matter by the end of this month.
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.
