MBI passes milestone in contrast effort
The Food and Drug Administrationhas granted Molecular Biosystems (MBI) an "approvable letter"for its Albunex ultrasound contrast agent, the San Diego pharmaceuticaldeveloper reported last week. The letter outlines some final requeststhat, once
The Food and Drug Administrationhas granted Molecular Biosystems (MBI) an "approvable letter"for its Albunex ultrasound contrast agent, the San Diego pharmaceuticaldeveloper reported last week. The letter outlines some final requeststhat, once met, will mean that the agent fulfills all requirementsfor final FDA approval. If approved, Albunex would be the firstultrasound imaging agent cleared for commercialization in theU.S.
MBI indicated that most of the requests were minor, relatingto labeling and other specifications, and the firm will respondto them "in the next few days." The agency has alsoasked that MBI conduct postapproval studies on any adverse deviceeffects (ADEs) of Albunex. MBI indicated that all ADEs of Albunexfound during clinical trials were minor and resolved without treatment.
Mammography Study Compares False Positives Between AI and Radiologists in DBT Screening
May 8th 2025For DBT breast cancer screening, 47 percent of radiologist-only flagged false positives involved mass presentations whereas 40 percent of AI-only flagged false positive cases involved benign calcifications, according to research presented at the recent American Roentgen Ray Society (ARRS) conference.
