The FDA has approved a label change to Bracco Diagnostics‘ MultiHance MRI contrast agent. The company’s product can now be used to visualize lesions with abnormal vascularity of the brain and spine in patients younger than two years old. Data collected in pediatric patients under the age of two showed that a dose of 0.05 mmol/kg […]
Bracco Imaging has launched a new effort at its Switzerland-based R&D center to evaluate gas-filled microbubbles, usually used for diagnostic imaging, as a delivery vehicle for personalized gene therapies to treat chronic dysfunctional diseases linked to lipid metabolism. The research project is part of a deal that Bracco signed with startup SonoGene, which is developing platforms […]
Bracco Imaging said today it acquired real-time fluorescence image guided surgery start-up SurgVision for an undisclosed amount. Netherlands-based SurgVision is developing a real-time fluorescence image guided surgery platform which combines targeted imaging agent and a tumor visualization device designed for use during oncology surgical procedures, Bracco said. “With the acquisition of SurgVision, one of the […]
HLT said today that it launched a feasibility trial of its Meridian TAVR in a high-risk patient cohort. Maple Grove, Minn.-based HLT said the 20-patient Radiant study is a prospective, non-randomized, single-arm trial with an endpoint of all-cause mortality at 30 days. Follow-up is slated for 1, 5 and 12 months after implantation, and then annually to 5 […]
Bracco Imaging U.S. subsidiary Bracco Diagnostics said today that it won FDA approval for its Lumason microsphere contrast agent to be used in ultrasonography of the urinary tract in pediatric patients with suspected or known vesicoureteral reflux. “The approval of Lumason for voiding ultrasonography answers an unmet medical need for an effective imaging study to […]
Bracco Diagnostics said yesterday it won FDA premarket approval for its Lumason ultrasound imaging agent, now indicated for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients. Marketed in other countries as SonoVue, Lumason is a contrast agent made up of gas-filled microbubbles, or microspheres, that reflect sound […]
Simbionix USA Corp. acquired the Arthro VR arthroscopic training simulator line from Spain’s GMV for an undisclosed amount.
The deal broadens Simbionix’s footprint in the orthopedic training arena. The Arthro VR features a line of simulated procedures using fiberglass limb replicas, 3D images and haptic sensation.