• bioMérieux (Marcy L’Etoile, France) has received FDA clearance to market Vidas B R A H M S PCT. The test will be used with critically ill patients on their first day of admission to the ICU as an aid to assess their risk for progression to severe sepsis and septic shock. The Vidas platform is well suited to emergency situations, with Vidas B R A H M S PCT providing test results in 20 minutes. The new test completes the large Vidas emergency panel available in the U.S., which includes markers of cardiac necrosis (Vidas Troponin I, CK-MB) and venous thromboembolism (Vidas D-Dimer Exclusion). BioMérieux specializes in in vitro diagnostics.

• CMS (St. Louis) received FDA clearance for Monaco, its IMRT planning platform. This clearance allows CMS to begin distributing Monaco for clinical use in the U.S. Monaco features biological cost functions with multi-criterial constrained optimization, a powerful leaf sequencer, and a robust Monte Carlo dose calculation algorithm. CMS makes radiation treatment planning and workflow management solutions.

• Ingen Technologies (Nyucaipa, California) said that OxyAlert is expected to receive an “exempt” status from the 510(k) filing in 60 days. OxyAlert is a new medical technology that uses wireless communication to send information related to the status of an oxygen delivery system to a remote receiver. Using a special microchip referred to as ZigBy, OxyAlert complies with the medical standards for wireless communication, and at the same time provides patients and caregivers the ability to distance themselves from the oxygen delivery system and still monitor the amount of oxygen being delivered. Ingen Technologies is a medical device manufacturer.

• InterSystems (Cambridge, Massachusetts) reported that the Group Health healthcare system has completed rolling out the Progeny Anatomic Pathology (AP) information system from PathView Systems, an InterSystems application partner. The implementation, which has already delivered significant error reduction and a dramatic increase in workflow efficiency, is built on the InterSystems CACHÉ high-performance object database. Its product line includes the InterSystems CACHÉ object database, InterSystems Ensemble rapid integration platform, and InterSystems HealthShare platform for regional and national electronic health records.

• Medical Decisions Network (Charlottesville, Virginia) reported FDA clearance of its MDN-CGS IV insulin dosing software. The MDN-CGS software is used by hospital nurses to quickly and accurately calculate the dosage of intravenous insulin administered to patients with elevated levels of blood glucose, the simple form of sugar the body converts to energy for survival. The MDN CGS is a networked application, accessible from any computer on a hospital’s network. This means that clinicians can continue a patient’s infusion progress even when the patient is moved to a new unit. Medical decisions network makes connectivity solutions for clinical laboratory point-of-care data management.

• Nihon Kohden America (Irvine, California) reported the development of Prefense, an early detection and notification system that allows hospital patients to freely ambulate while measuring HR, NIBP, Sp0₂ and respiration — 4 of the 7 critical parameters that trigger a rapid response team. Prefense is combined with the company’s NTX wireless telemetry transmitters. Prefense is the only solution that seamlessly integrates the mobility of Nihon Kohden America’s NTX, the advance warning capabilities of continuous trend analysis and the proven effectiveness of rapid response teams. Nihon Kohden America makes patient monitoring systems.

• PerkinElmer (Waltham, Massachusetts) reported a complete analytical solution for the determination of melamine adulteration in protein-based foods. With the release of the Melamine Analyzer, based on the innovative Clarus 600 T Gas Chromatograph/Mass Spectrometer (GC/MS), PerkinElmer is the first in the industry to provide such a solution using GC/MS technology, it said. The Melamine Analyzer includes all instrumentation, consumables and applications resources needed to screen for melamine contamination, conforming with the most recent guideline from the FDA. Melamine is a nitrogen-rich industrial chemical that became well-known in North America recently after its presence in wheat gluten was linked with renal failure in dogs and cats. PerkinElmer specializes in the health sciences and photonics markets.

• Positron (Hoston) introduced their new dedicated Cardiac PET system at the annual meeting of the American Society of Nuclear Cardiology. Positron’s new Attrius molecular imaging system incorporates software and hardware technology for the diagnosis and treatment of patients with heart disease. Positron offers a combination of low cost technology and disease specific software solutions differentiating themselves from all other medical device manufacturers. Positron makes cardiac molecular imaging devices using single photon emission computed tomography and positron emission tomography.

• Smiths Detection (Boston) said that it will launch a portable detection system that will enable veterinarians to carry out on-site diagnosis of animal diseases such as foot-and-mouth and avian flu. This new technology means vets will be able to diagnose diseases in livestock and birds in the field in less than 90 minutes rather than having to send samples for laboratory analysis. The new portable device is specifically designed to be used by vets wherever livestock are kept and comprises a simple-to-use sample preparation cartridge and a rugged portable instrument. The technology employed is a novel form of polymerase chain reaction (PCR), a well established technique for the detection and analysis of infectious diseases. Smiths Detection is part of the global technology business Smiths Group. It makes integrated security solutions for customers in civil and military markets.

• SonoSite (Bothell, Washington) introduced the S-ICU visualization tool, the first ultrasound device custom-designed for the intensive care physician. With the S-ICU tool, intensivists get the image quality of SonoSite’s M-Turbo system with the user interface, software and controls specialized to address the point-of-care exams and procedures commonly performed in a hospital ICU. The system boots from a cold start in seconds and the optimal image can be acquired immediately with just two controls. Weighing 8.35 pounds, the S-ICU tool can be easily carried, mounted on an IV pole, or fixed on a wall or ceiling for zero footprint, and survive being dropped from three feet onto a hard surface. Its sealed interface can be easily wiped down with disinfectant, which is crucial for reducing infection risk in an ICU. SonoSite makes hand-carried ultrasound products.