• GenMark Diagnostics (Carlsbad, California) said it has submitted to FDA, for 510(k) clearance, a Respiratory Viral Panel for use on its eSensor XT-8 system. The test is designed to identify multiple viruses from individuals exhibiting signs and symptoms of respiratory infection. The eSensor Respiratory Viral Panel is designed to be a fast molecular diagnostic test to provide accurate results while requiring less technologist time. “The submission to the FDA of our eSensor Respiratory Viral Panel is an important step in GenMark's continued commitment to providing our customers with high quality in- itro diagnostic molecular tests for use with our award winning eSensor XT-8 system,“ said Hany Massarany, president/CEO of GenMark Diagnostics. The company says using GenMark's eSensor detection technology, GenMark's eSensor XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact workstation and self-contained, disposable test cartridges.

• Royal Philips Electronics (Amsterdam, the Netherlands) said Medical City Dallas Hospital is the first hospital in the U.S. to use Philips' HeartNavigator interventional tool in clinical practice. HeartNavigator is a new procedure planning and image guidance tool to help interventional cardiologists and cardiac surgeons perform minimally invasive heart valve replacements. Developed in cooperation with partner hospitals around the world, HeartNavigator is designed to increase the objectivity of the procedure planning and to simplify the procedure itself. By doing so, it aims to reduce the burden on patients and improve patient care. In contrast to open heart surgery, which involves significant opening up of the patient's chest, minimally invasive heart valve replacement only requires a small incision, through which catheters are inserted and guided to the heart with the aid of dedicated interventional X-ray systems.

• Syprosoft Engineering reported the completion of the design of a disposable drug delivery device for Surgin (both, Irvine, California). The design process included fluid flow analysis, stress calculations, materials selection, ergonomics, rapid prototyping and pre-clinical bench-top testing. The entire effort was completed in about five months. Surgin makes medical devices specializing in the design and manufacture of surgical devices for specialties including arthroscopy, ophthalmology, hand surgery, endoscopy and colon/rectal surgery.

Bioengineers at Tufts University School of Engineering (Somerville, Massachusetts) have developed a new silk-based microneedle system able to deliver precise amounts of drugs over time and without need for refrigeration. The tiny needles can be fabricated under normal temperature and pressure and from water, so they can be loaded with sensitive biochemical compounds and maintain their activity prior to use. They are also biodegradable and biocompatible. The Tufts engineers made the aluminum microneedle molding masters which were fabricated into needle arrays of about 500 (micro)m needle height and tip radii of less than 10 (micro)m. The elastomer polydimethylsiloxane (PDMS) was cast over the master to create a negative mold; a drug-loaded silk protein solution was then cast over the mold. When the silk was dry, the drug-impregnated silk microneedles were removed. Further processing through water vapor annealing and various temperature, mechanical and electronic exposures provided control over the diffusity of the silk microneedles and drug release kinetics.