• Aerogen (Mountain View, California) said it has received fast track designation from the FDA for its combination product, Amikacin Pulmonary Delivery System for Ventilator-Associated Pneumonia (VAP). The product is Aerogen's lead drug/device combination product incorporating the company's OnQ Aerosol Generator technology adapted for high-efficiency aerosol delivery to patients on mechanical ventilators. The fast track program was created by the FDA to facilitate the development and expedite the review of a new product that is intended for the treatment of serious or life-threatening conditions and demonstrates the potential to address unmet medical needs for such conditions.

• Biosite (San Diego) said the FDA has accepted the company's Triage Stroke Panel premarket approval application (PMA) for further review. The panel is intended for use as an aid in the assessment and diagnosis of cerebral ischemia, or stroke. The Triage Stroke Panel consists of multiple biomarkers and uses a proprietary algorithm to calculate a single MultiMarker Index result. Biosite submitted its PMA for the Triage Stroke Panel in December. Existing methods to diagnose stroke and confirm symptoms utilize radiographic imaging, such as computed tomography, which are subject to interpretation and often unable to detect the most common form of stroke until 12 to 24 hours after an event. Currently in the U.S., there is no rapid, in vitro diagnostic test using protein markers from a blood sample commercially available for use as an aid in the diagnosis of stroke.

• CryoVascular Systems (Los Gatos, California) said Texas Heart Institute (Houston) physician Zvonimir Krajcer, MD, said during the International Congress on Endovascular Intervention in Phoenix that the company's CryoPlasty cooling therapy to treat blood vessel blockages showed success in remedying difficult-to-treat blockages. “Our early findings suggest the CryoPlasty technique is a simple, yet very effective therapy for treating a wide variety of PAD [peripheral artery disease] blockages,“ said Krajcer, program director for the peripheral vascular program at Texas Heart Institute and St. Luke's Episcopal Hospital (also Houston). “We had very good success treating the blockages with CryoPlasty therapy alone.“ In the single-center study, 51 patients received CryoPlasty therapy via the PolarCath System for 64 blockages, the majority in the thighs, abdomen or lower legs and follow-up ranged from three months to one year. After CryoPlasty therapy, only two of the blockages (3%) required placement of a stent. Fifty-three percent of the patients had critical limb ischemia, meaning their lower leg arteries were so severely blocked that they suffered pain in their legs and were at risk of amputation of a foot or leg. To date none of the patients have required amputation. CryoPlasty therapy cools and opens arteries clogged with plaque due to PAD, which is estimated to affect about 10 million people in the U.S.

• Medtox Scientific (St. Paul, Minnesota) said it has filed a 510(k) application with the FDA for clearance to market its Sure-Screen drugs-of-abuse point-of-collection test device. Sure-Screen is intended to provide lower detection levels for eight commonly abused drugs. Sure-Screen will provide lower detection levels on eight drugs (marijuana, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamines and MDMA (Ecstasy) by an average of about 50% each. The company said it believes there is a demand for lower detection levels in certain markets, including probation, parole, rehabilitation, hospital emergency departments and corporate clients interested in lower detection levels for pre-employment testing.