• PARI Respiratory Equipment (Midlothian, Virginia) said its new PARI Hydrate G, the first heat and humidification system that uses C-Force technology, received FDA 510(k) clearance and will be available for sale in July. Infant, pediatric, and adult patients that are put on oxygen through a nasal cannula need humidified gas at the correct temperature for proper treatment. Hydrate not only delivers saturated and heated gas but is small and light enough to introduce the therapy near the patient, eliminating the need for large bore tubing or heated wires, the company said. The PARI Hydrate G.33 with C-Force Technology uses a capillary force vaporizer, which is about the size of a large aspirin tablet and made of ceramic to heat and humidify up to 50 L/min of gas flow. When water is supplied to the bottom of the disc, capillary forces draw the liquid into the disc, similar to the way water is brought to the top of a tree. Heat is then applied through the top of the disc and the water undergoes phase transition into a vapor, expands, and is released under pressure through an opening. PARI is a worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, and cystic fibrosis.

• Positron (Houston), through its R&D affiliate, has filed a provisional patent for a device that is capable of detecting illicit radioactive sources at a distance. The processes and techniques used in the development of the radiation detection devices arose as a result of Positron's long history in the field of medical imaging and positron emission mammography, or PET scanners. A PET scanner is a sensitive radiation detection device that detects cancer-seeking radiopharmaceuticals injected into the human body. PET scanners operate at close distances to the body. Radiation detection devices for Homeland Security must be able to detect potential nuclear threats at much lower dose levels than used in PET and in a much shorter time period, from as far as 100 meters away. The new stand-off radiation scanner (SORAC) incorporates solid-state photodetectors developed by the Positron affiliate's scientific team.

• USGI Medical (San Clemente, California) reported the use of its recently FDA-cleared EndoSurgical Operating System (EOS) in two different surgical procedures. Incisionless EndoSurgery is the next wave in minimally invasive surgery and this new technique has generated intense interest among physicians in the surgical areas of Obesity, GERD, Natural Orifice Translumenal Endoscopic Surgery and advanced therapeutic endoscopy, the company said. USGI was founded in 2001 to develop technology for Incisionless EndoSurgery.

• Verax Biomedical (Worcester, Massachusetts), a developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has submitted a 510 (k) application to the FDA for its Platelet PGD Test. The filing is based on data gathered at three major U.S. hospitals and is intended to demonstrate that the performance of the product is substantially equivalent to existing FDA cleared tests for the detection of bacterial contamination in platelets. FDA clearance of the test would permit Verax to market the device, which cuts the detection time for bacterial contamination to about 30 minutes compared to the one- to three-day detection times of currently available tests. Recently, Abbott Diagnostics (Abbott Park, Illinois) signed a worldwide exclusive agreement to market and distribute the product, and British Biocell International (BBI; Cardiff, Wales) signed a 10-year contract to provide gold colloid and manufacturing.

• Wyndgate Technologies (Denver) reported that it has submitted a 510(k) application to the FDA for its ElDorado Donor Doc software for clearance. Donor Doc is an electronic health history questionnaire and physical exam tracking system intended to assist blood donor centers with screening donors and capturing relevant medical information. This software has been designed to automate screening processes to provide data quality assurance and supporting regulatory compliance. The software is intended to interface with central blood management systems, to allow easy access to donation information, to identify missing or suspect data, to record physical exam results, as well as to capture digital signatures and donor photographs. Wyndgate is a division of Global Med Technologies (El Dorado Hills, California), an e-Health medical information technology company.