• Accelrys (San Diego) reported the release of SciTegic Enterprise Server 7.0, a platform for the integration, analysis, and reporting of scientific data. Key features of the new release, which is the next generation of the Pipeline Pilot platform, include a service-oriented architecture environment, enterprise collaborative tools, interactive application building, and workflow parallelization. Accelrys makes scientific business intelligence software.

• 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.

• Angiotech Pharmaceuticals (Vancouver, British Columbia), received 510(k) clearance from the FDA for its 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC). The catheter is the first drug-eluting medical device product to be researched and developed completely in-house by Angiotech's R & D and clinical teams, without the aid of a corporate partner. The company said 5-FU, which it termed "a well-known and FDA-approved drug," has "effectively demonstrated" its ability to prevent catheter-related infections as compared with CH-SS-coated catheters. Angiotech said that, since 5-FU is not routinely used as either a systemic antibiotic or a hospital antiseptic, "There may be a reduced risk to the hospital or the community at large of creating a 'Super Bug' that is resistant to useful classes of antibiotics and antiseptics and may make infection control more complex."

• DynaMed Systems (New York) reported FDA approval of its investigational device exemption (IDE) application to study the Traxon Spinal Cord Repair Stimulation System (Traxon system) in acute spinal cord injured patients. The study is designed to assess the safety and effectiveness of the Traxon, a surgically implanted DC powered device, to improve motor function and other functional assessments in acute complete and incomplete SCI patients. DynaMed Systems' technology applies oriented and linear electrical fields to damaged nerve fibers. The clinical study will test the ability of the device to safely repair and improve function in those damaged nerves. DynaMed Systems makes products that promote the regeneration and recovery of the central nervous system, the peripheral nervous system and other soft tissues such as tendons, ligaments and skin.

• Response Biomedical (Vancouver, British Columbia) said it has received FDA 510(k) clearance for its rapid Influenza A+B test (Flu A+B test) and a new version of the RAMP Reader, the RAMP 200. The test manufactured by Response runs on the new RAMP 200 Reader and will be marketed and sold worldwide exclusively by 3M Health Care as the 3M Rapid Detection Flu A+B Test. It is a qualitative immunochromatographic assay indicated for use as an in vitro diagnostic product with the 3M Rapid Detection Reader, also manufactured by Response, to identify the presence of Flu A and Flu B nucleoprotein antigen in nasopharyngeal swab, nasopharyngeal aspirate, nasal wash/aspirate specimens. 3M Health Care said it anticipates launching prior to the 2008-09 flu season in certain markets around the world.