Sonus Pharmaceuticals has announced that the Food and Drug Administration will not require a Medical Imaging Drug Advisory Committee (MIDAC) meeting to complete the review of the Bothell, WA-based company's EchoGen ultrasound contrast agent. In reaching
Sonus Pharmaceuticals has announced that the Food and Drug Administration will not require a Medical Imaging Drug Advisory Committee (MIDAC) meeting to complete the review of the Bothell, WA-based company's EchoGen ultrasound contrast agent. In reaching its decision, the FDA indicated that it was comfortable with the general issues regarding the class of products including ultrasound contrast agents, according to the company.
The comfort level apparently evolved out of a Radiology Device Advisory Committee meeting held earlier this year for FS069 (now Optison), an ultrasound contrast agent from Molecular Biosystems (SCAN 3/5/97). The ruling bypassing the need for an advisory committee meeting was exclusive to EchoGen, however, said Kelly Ford, communications director for Sonus. Officials at Molecular Biosystems were unavailable for comment. Sonus would not speculate on how much time the FDA's decision would cut off EchoGen's review time.
FDA Clears Virtually Helium-Free 1.5T MRI System from Siemens Healthineers
June 26th 2025Offering a cost- and resource-saving DryCool magnet technology, the Magnetom Flow.Ace MRI system reportedly requires 0.7 liters of liquid helium for cooling over the lifetime of the device in contrast to over 1,000 liters commonly utilized with conventional MRI platforms.
SNMMI: Botox May Facilitate Relief from Dry Mouth Side Effect of PSMA-Targeted Radiopharmaceuticals
June 25th 2025For patients being treated with radiopharmaceutical agents for metastatic prostate cancer, the combination of botulinum toxin and an anti-nausea patch led to a 30 percent reduction in PSMA uptake in the salivary glands, according to preliminary research findings presented at the SNMMI conference.