• Bio-Medical Devices (Irvine, California) reported the release of its Maxair 710-DLC Computerized Air Purifying Respirator (CAPR). The company says the 710-DLC CAPR is the latest evolution of the patented hose-free MAXAIR Systems design is targeted specifically for routine infection prevention in hospitals and long-term care units. Bio-Medical claims the key ingredient of the new MAXAIR System is the DLC itself, a unique Disposable Lens-Cuff. When compared to an N95 mask respirator and goggles, it is easier to don and doff and provides inherently greater protection. It is price competitive with the N95 mask plus goggles that the healthcare professionals need to wear for minimum protection when caring for isolation patients with TB, various influenzas, etc.

• DxNA (St. George, Utah) said it has submitted a request to the FDA for Emergency Use Authorization (EUA) for its GeneSTAT pathogen platform, for the detection of the H1N1 virus (known as swine flu). The GeneSTAT platform includes a portable device that offers remote usage to rapidly detect pathogens where outbreaks are suspected. The device can be used in gateway airports, at local health departments and schools, where on-site rapid and non-invasive screening for highly contagious pathogens is advised. The GeneSTAT test module requires a swab of the mouth, nose or throat.

• Orthovita (Malvern, Pennsylvania), reported it received FDA 510(k) clearance to market Cortoss Bone Augmentation Material for treatment of vertebral compression fractures. Cortoss is an injectable, bioactive composite that mimics the physiological properties of human cortical bone and is the first alternative to polymethylmethacrlyate (PMMA) cement that has been evaluated in a large-scale, multi-center, randomized, controlled clinical study and now cleared in the U.S. for the treatment of vertebral compression fractures. "Every year roughly 250,000 people in the United States undergo augmentation procedures such as vertebroplasty and kyphoplasty for painful fractures in the spine. Since the inception of the vertebroplasty procedure in the mid 1980s, PMMA has been the only viable implant for vertebral augmentation," said President/CEO Antony Koblish. "Cortoss is the first FDA-cleared alternative in this product category. Our experience and research to date shows that physicians and their staff are pleased with the innovative handling and biomechanical characteristics that Cortoss offers." Cortoss Bone Augmentation Material is a blend of cross-linking resins and reinforcing fillers, which include the proprietary bioactive glass found in Orthovita's Vitoss Bioactive Foam products.

• Royal Philips Electronics (Andover, Massachusetts) introduced its microTEE, which it calls "the world's smallest transesophageal echocardiography (TEE) transducer for cardiac imaging of neonatal patients." As part of the latest Vision release for the Philips iE33 intelligent echocardiography system, the microTEE transducer provides pediatric cardiologists with a diagnostic tool for imaging the hearts of newborn patients. Philips microTEE is being showcased at the 20th annual American Society of Echocardiography meeting in Washington and will be available for sale globally this summer. Philips said that due to the larger size of previously available pediatric TEE transducers, small babies have been impossible to image during critical cardiac catheterization or surgical procedures. As a result, high-risk procedures have been done routinely on these tiny patients without transesophageal echocardiography images available to the interventionalist or surgeon. The microTEE transducer is roughly one-third the size of previous pediatric TEE transducers, allowing physicians to 'turn on the lights' for the first time for their tinier patients and providing the images they need during interventional procedures. The microTEE also is entering trials for adult patients requiring TEE imaging, but who have difficulty tolerating standard TEE probes.

• SleepEx (Blue Bell, Pennsylvania), a provider of lab and data management solutions in the growing sleep diagnostics industry, said it has elevated its online suite of electronic medical record solutions with ZMR Green. Citing increased functionality, reduced costs and its Go Green approach; SleepEx said it has transformed its product and the way it does business for 2009, "with benefits for the sleep community and the planet." In addition to financial savings related to implementing a paperless system, SleepEx makes extensive use of "virtualization" with respect to training, implementation, customization and even archiving of data. Some of the "green" results noted in ZMR include eliminating faxing, paper charts, burning DVDs and directly reducing fuel consumption and emissions by offering browser-based patient access for physicians who sometimes travel to five or six locations.