Sonus turns up volume in ultrasound tussle
Sonus turns up volume in ultrasound tussle Competitors stepped up their efforts to derail the FDA's consideration of Molecular Biosystems Inc. 's FS069 ultrasound imaging agent as a device, as Sonus Pharmaceuticals Inc. filed a citizen petition asking the FDA to regulate all ultrasound contrast media as drugs, and asking the agency to stay its decision to file the PMA for FS069.
Another ultrasound company, Bracco Diagnostics Inc .(Milan, Italy) filed a similar petition in January (see BioCentury, Jan. 27).
In its petition, SNUS (Bothell, Wash.) asked that all ultrasound contrast media be regulated through the Center for Drug Evaluation and Research (CDER) rather than