FDAnews Device Daily Bulletin

The Bush administration nominated FDA acting Commissioner Lester Crawford as commissioner of the FDA, a position that has been vacant since March 2004.

St. Jude Medical has signed a definitive agreement to acquire the business of Velocimed, a privately owned company located in Maple Grove, Minn., that develops and manufactures specialty interventional cardiology devices.

Researchers recently implanted in the first patient in the U.S. a new, high-power investigational neurostimulation system being developed by Medtronic for chronic pain patients.

BIOLASE Technology, a medical technology company focused primarily on dentistry and related specialties, has been granted a new European patent protecting key areas related to its core water and laser technology.

Hospira, a developer of medication delivery systems, and Bridge Medical, a patient safety software and services company, and subsidiary of AmerisourceBergen, have announced a development agreement to create a new, wireless point-of-care medication management solution that links intravenous devices at the patient bedside with barcode enabled medication administration verification systems.

Vision-Sciences, which makes endoscopic products using disposable sheaths, has announced the sale of roughly 3.7 million shares of common stock for roughly $10 million in a private equity placement.

Clinical Data announced that it has entered into a distribution agreement with Daiichi Pure Chemicals of Tokyo. Under this agreement Clinical Data will serve as the master distributor for a new diagnostic assay for the measurement of Prostate Specific Antigen, or PSA, a marker for the presence of prostate cancer.

NanoHorizons, a maker of applied nanoscale materials and solutions, announced that it has been awarded a patent covering the company's deposited thin-film system for high-throughput small-molecule mass spectrometry.

Aesthera, a U.S.-based start-up founded by former Lumenis employees, announced that it had raised $6.5 million in its second financing round.

CardioSoft announced it has completed initial assessments and will proceed with commercialization of a novel High Frequency QRS Electrocardiogram (ECG) technology (HFQRS-ECG) through exclusive licensing from NASA.

Bio-Matrix Scientific Group announced that it is developing a proprietary polymer coating for its stem cell and tissue management instruments that will lead to reduced friction in procedures and greater predictability in outcomes for patients.

OrthoClear filed a multiclaim lawsuit in San Francisco County Superior Court against defendants Align Technology, a Delaware corporation, Thomas Prescott, Roger George, Eldon Bullington, Patricia Wadors, Gil Laks, David Thrower, Kelsey Wirth, among others.

Dynamic Decisions, a provider of independent analytical research and valuation analysis to fund managers and institutional investors worldwide, announced that it has initiated coverage of Milestone Scientific of Livingston, N.J., a company that has developed and currently manufactures, markets and sells a proprietary, computer-controlled system for the improved and painless delivery of local anesthetic.

ChromaVision Medical Systems, a technology and services resource for pathologists, oncologists and the pharmaceutical industry, announced that it is changing the name of the corporation to Clarient in order to better reflect a new strategy, direction and business plan that have been expanded to serve three distinct markets.