• Acusphere (Watertown, Massachusetts) reported the submission of a new drug application (NDA) to the FDA for approval to market its lead product candidate, Imagify (Perflubutane Polymer Microspheres for Injectable Suspension). Imagify is an ultrasound imaging agent for the detection of coronary artery disease, designed to assess blood flow in the heart (myocardial perfusion). The company believes it also is the first ultrasound imaging agent to demonstrate in large clinical trials clinically equivalent accuracy to nuclear stress testing, the current standard for assessing myocardial perfusion. Acusphere said Imagify is designed to provide "real-time perfusion information with quicker results, lower cost, broader access and no exposure to radiation compared with nuclear stress tests." Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using microsphere technology.

• Fluidigm (South San Francisco, California) reported the availability of its new BioMark IFC controller MX, part of the company's complete system for high-throughput genetic analysis. The BioMark IFC controller MX is targeted for set up of high-throughput gene expression, genotyping, and digital PCR experiments. It features a menu for automatically loading BioMark 48.48 dynamic arrays and 12.765 digital arrays. The IFC includes built-in software and a self-contained gas source for pressure-loading samples and assays into the dynamic arrays and digital arrays. The BioMark system is a combination of integrated fluidic circuit chips, instrumentation and applications software. Fluidigm makes integrated fluidic circuit systems.

• The Navigation and Intra-Operative Imaging division at Medtronic (Minneapolis) introduced the StealthStation S7 system. "The StealthStation S7 system is the next generation of navigation providing both flexibility and simplicity to enable a more efficient neurosurgical practice," said Jim Cloar, GM of the Navigation division at Medtronic. "The solution improves OR workflow and helps bridge the gap that can exist between the complexities of neurosurgery and the training pressures caused by rotating OR staff." The StealthStation S7 combines pre-operative images with live data during surgery to show surgeons exactly where they are in a procedure. It is designed to enhance a surgeon's ability to perform precise procedures, including Medtronic's own neuro-oncology, sinus, hydrocephalus, and deep brain stimulation therapies.

• Mirabilis Medica (Bothell, Washington) reported completion of its first human trial, which served as a preliminary demonstration of clinical feasibility of its prototype high intensity focused ultrasound (HIFU) system for treatment of uterine fibroids. Volunteer patients were treated with the Mirabilis system just prior to scheduled hysterectomies, after which the excised uterine tissue was examined by a pathologist for effects of treatment. Fibroids are extremely common benign tumors of the uterus which can substantially impact quality of life. Symptoms can include heavy or prolonged menstrual bleeding, pelvic cramps, urinary frequency or urgency, and pregnancy loss or infertility. Mirabilis Medica combines the application of therapeutic ultrasound under real-time guidance of imaging ultrasound.