• Allergan (Irvine, California) reported its Ozurdex injectable eye implant has been approved by FDA and is the first product sanctioned to treat the eye disorder macular edema when it is caused by blockage of the retinal vein. The Ozurdex eye implant treats macular edema by delivering a high concentration of the corticosteroid dexamethasone.

Baxa (Englewood, Colorado) reported the release of upgrades to its IntelliFlowRx workflow management system. IntelliFlowRx is designed to improve safety and accuracy in pharmacy-based IV admixture preparation. The system also streamlines compliance with sterile preparation regulatory steps while improving visibility to and oversight of IV room operations. The latest upgrade adds a number of features to the IntelliFlowRx System, including the ability to define specific workflows for different types of doses within the health-system pharmacy, i.e., preparation modes and drug delivery routes – enabling customers to prepare oral liquid doses using IntelliFlowRx.

• BioMimetic Therapeutics, (Franklin, Tennessee) reported it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its pre-market approval (PMA) application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The company intends to file the third and final module, containing the clinical data, in the 4Q09. BioMimetic Therapeutics, is developing and commercializing regenerative protein-device combination products for the healing of musculoskeletal injuries and disease, including orthopedic, spine and sports injury applications.

• Calypso Medical Technologies (Seattle) reported the publication of three new studies investigating the role of the Calypso 4D Localization System in guiding immediate adjustments to radiation delivery in response to tumor motion, a concept known as real-time adaptive radiation treatment. The first study demonstrates how the Calypso System is integrated with the linear accelerator – the equipment used to deliver radiation to cancerous tumors – to gate the radiation beam when the tumor motion exceeded certain thresholds. For the first time, the ability to automatically turn the beam on and off, termed "gating," has been demonstrated utilizing internal information that reflects how the tumor is moving rather than relying on external markers. Gating the beam based on actual tumor motion improves the quality of treatment that the patient receives. The other studies highlight that Calypso System data can be used to adapt treatment by guiding the multi-leaf collimator – the part of the linear accelerator used to shape the radiation beam – thereby moving it in real time.

• Misonix (Farmingdale, New York), a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, said that its subsidiary, Sonora Medical Systems,NULL, a supplier of after-market products, training, depot-level repair and support services, and test equipment to the medical imaging market, reported it has achieved ISO 17025 accreditation for its Acoustic Power Testing Laboratory. Acoustic power testing is a requirement for ultrasound system and probe manufacturers to obtain FDA 510(k) clearance of their products, as well as meet the International IEC60601 standards. In addition to the important foundation of a quality management system, the ISO 17025 standard specifically addresses the technical competence of the laboratory staff, the validity and appropriateness of the test methods, traceability of measurements to national standards, appropriate application of measurement uncertainty, suitability of test equipment and environment, and the quality of the test results and reports. Test data from ISO 17025 accredited laboratories is more readily accepted by worldwide regulatory and safety organizations, reducing cost and time to market globally for manufacturers.

Noldus Information Technology (Wageningen, the Netherlands) reported the release of the Observer XT 9.0, the company's behavioral research software. Along with this release, Noldus announced the launch of Pocket Observer 3.0. It helps perform behavioral coding on a handheld computer. New features include the advanced find functionality to explore results and retrieve information quickly, support for coding in Chinese and Japanese characters, a RSS feed integrated in the software for easy access to downloads and extensive documentation, and the opportunity to combine time sampling with continuous recording during the observation.

• Noteworthy Medical Systems (Phoenix) reported the release of NetPay, a web-based application that integrates with NetPracticePM to enable physicians' offices to collect all patient payments at the point of service when patients are still in the office. Powered by mPay Gateway, NetPay electronically collects deductibles, out-of-pocket patient payments and co-pays before the patient leaves the office. The software captures patient payment authorization at the point of service for automatic and immediate collection of patient balances upon receipt of a remittance advice from the patient's insurance typically 30 days later. This occurs without the practice ever sending a bill to the patient.