FDAnews Device Daily Bulletin

I-Flow has announced that a long-term study on the use of ON-Q PainBuster following breast cancer surgery showed that the benefits of ON-Q not only reduced acute pain after surgery, but also helped patients have less pain with daily activities over time.

The FDA has approved Roche Diagnostics' COBAS AmpliScreen HIV-1 and hepatitis C (HCV) tests to screen cadaveric organ and tissue donations -- the expanded claim for screening blood samples from these donors is in addition to testing whole blood, source plasma and potential living organ donors.

The Scripps Clinic has initiated a physician-sponsored clinical trial of FlowMedica's Benephit Infusion System in patients with chronic kidney disease who are undergoing cardiovascular procedures and are at increased risk for developing a potentially life-threatening condition called radiocontrast nephropathy (RCN).

Siemens Medical Solutions has introduced the SOMATOM Emotion 16, its newest 16-slice computed tomography (CT) system.

RheoGene announced that it has granted a nonexclusive worldwide license to Genomatix to produce custom DNA vectors that incorporate RheoGene's RheoSwitch inducible gene regulation technology.

ChondroGene reported that it has received a contribution from National Research Council's Industrial Research Assistance Program (NRC-IRAP) in support of the development of a blood-based molecular diagnostic assay that will be able to detect early, asymptomatic osteoarthritis as well as stage the severity of the disease.

Coronado Industries, the manufacturers of unique proprietary pneumatic devices for the non-invasive treatment of glaucoma through its wholly owned subsidiary, Ophthalmic International, announced they have recently entered into a services agreement with ClinReg Consulting Services of Irvine, Calif., to assist the company in achieving the regulatory approval necessary to allow the introduction of Coronado's PNT (Pneumatic Trabeculoplasty) technology in the U.S.

VIASYS Healthcare announced that it has signed a definitive agreement to acquire Micro Medical for a purchase price of approximately $39 million.

Akers Biosciences announced the company has received $2.5 million, the principal amount of promissory notes convertible into shares of the company's common stock.

Huntleigh Healthcare announced a new three-year contract with Novation, the supply company of VHA and the University HealthSystem Consortium, effective April 1. The agreement covers Huntleigh's Flowtron Line of Intermittent Pneumatic Compression Devices for the prevention of deep vein thrombosis.

Aviva Systems Biology announced the launch of the ChIP-GLAS (Chromatin Immunoprecipitation-Guided Ligation And Selection) system, the core of its Gene Regulation Elements Mapping and Analysis (GREMA) Technology.

Gen-Probe, which develops, makes and markets nucleic acid tests, said its Aptima assay for the detection of Neisseria gonorrhoeae (GC) received marketing clearance from the FDA.

Illumina announced that it plans to release, by June 2006, a whole-genome microarray offering that will utilize the company's new Infinium assay and enable researchers to genotype one million Single Nucleotide Polymorphisms (SNPs) on a pair of Sentrix BeadChips.

Sky Capital Enterprises announced that its 40 percent owned subsidiary Advanced Spinal Technologies (AST) has completed and filed an application with the FDA seeking approval of the use in the U.S. of the pamm3 MicroManipulator to be marketed in the U.S. as the Technology Assisted Micro-manipulation and Reflex Stimulator -- an instrument intended for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine.