FDAnews Device Daily Bulletin

Paradigm Medical Industries has announced it has been awarded the CE Mark for a new generation ultrasound biomicroscope (UBM), enabling the company to market the device in 19 Western European countries and some parts of the Pacific Rim.

VISX has announced it received approval from the FDA to market and sell Iris Registration technology, the first fully automated method of aligning and registering wavefront corrections for CustomVue treatment.

Atrium Medical has announced it received CE approval for the HyperLite LX Rapid Exchange PTCA Catheter.

SmartPill Diagnostics, developer of the SmartPill Capsule -- a noninvasive, ingestible medical device that captures biomedical data from within the patient's GI tract - has announced that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are now underway at Massachusetts General Hospital.

Archus Orthopedics has announced that it has received CE Mark approval of its Total Facet Arthroplasty System (TFAS).

DiaDexus has announced submission of a 510(k) Premarket Notification to the FDA seeking marketing clearance for the PLAC test as an in vitro diagnostic product to help predict the risk for ischemic stroke.

Sicel Technologies has received a second grant from the Sisko Foundation to further develop the company's implantable sensor technology.

Bio-Matrix Scientific Group is negotiating a long-term contract with a major engineering and manufacturing firm to assist the company in product development and manufacturing of its stem cell and tissue management instruments.

Designed to further enhance the accuracy and efficiency of ultrasound imaging in the diagnosis and treatment of heart failure, Toshiba America Medical Systems introduced Dyssynchrony Imaging as the latest innovation to the Aplio CV, the company's all-digital ultrasound system for advanced cardiac applications.

Global nanotechnology company pSivida has announced it has signed an agreement with U.S.-based PureTech Development to investigate and evaluate out-licensing opportunities for BioSilicon with an emphasis on tissue engineering, wound management and orthopedics.

Procyon Biopharma has announced that it has entered into a licensing and distribution agreement with Medicorp granting the latter the exclusive worldwide rights to develop, manufacture and commercialize PSP94-based test kits for research purposes as well as the rights to sub-license for clinical diagnostic applications.

ThermoGenesis, a supplier of cryogenic devices used by cord blood banks, said that it is lauding a ruling by the U.S. Patent Office.

Axial Biotech has announced that it has completed its Series A round of financing, which raised $4.1 million.

Biosite, a research-based provider of novel, rapid medical diagnostics, has announced that the FDA has granted the company clearance to market the Triage TOX Drug Screen with Acetaminophen (APAP), the first drug screen to include a rapid, point-of-care test for the qualitative detection of acetaminophen in urine.