Advanced Accelerator Applications Sa, of Saint-Genis-Pouilly, France, reported a positive opinion from the European Medicines Agency on the marketing authorization application for the company's Somakit TOC 40µg, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for PET imaging of somatostatin receptor over expression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors for localizing primary tumors and their metastases. The European Commission decision on marketing authorization is expected in the coming months, the company noted.
Compulink Business Systems Inc., of Thousand Oaks, Calif., launched Otolaryngology Advantage, specific to the ear, nose, and throat space. The solution includes the company's Onetab, a single-tab exam layout designed so that physicians can view and document the exam from one screen.
Lumenis Ltd., of Yokeneam, Israel, introduced Otolase, an otology-designated enhancement for the company's Acupulse products, designed specifically for middle ear surgery.
Marqmetrix Inc., of Seattle, developed a Touchraman spectroscopy measurement device and is partnering with Metrohm Inc., of Riverview, Fla., to make Raman spectroscopy more accessible, accurate, and reliable. The Metrohm Mira is a compact Raman spectrometer for rapid, non-destructive identification of samples from a variety of industries.
The FDA cleared Shockwave Medical Inc.'s Lithoplasty system to treat calcified plaque in patients with peripheral artery disease. Shockwave, of Fremont, Calif., said the device integrates the calcium-disrupting power of sound waves with the simplicity of angioplasty balloon catheter devices. Intermittent lithotripsy pulses disrupt both superficial and deep vascular calcium, while minimizing soft tissue injury, and an integrated angioplasty balloon expands blockages at low pressures to restore blood flow.
Supersonic Imagine Sa, of Aix-Em-Provence, France, upgraded Aixplorer, its ultrasound system. In addition to better performance and efficiency, the software update includes a new Aixplorer breast package, Trivu real-time simultaneous mode with B-mode, Shearwave Elastograph and, color flow imaging. The software also includes a new feature called Trivu, which is designed to allow simultaneous visualization of anatomy, flow and tissue stiffness without any compromise.