FDAnews Device Daily Bulletin
Jan. 26, 2005 | Vol. 2 No. 18
Novadaq Technologies' SPY Intra-operative Imaging System has received 510(k) clearance from the FDA for use during Coronary Artery Bypass Surgery (CABG).
Angiotech has reported that European authorities handed down a favorable decision concerning the company's patents involving drug-coated stents.
The MedSystems business unit of VIASYS Healthcare, a provider of enteral feeding devices, has acquired substantially all of the assets of Navion Biomedical, manufacturer of the NAVIGATOR BioNavigation system.
Cook has announced the availability of the CODA balloon catheter to the endovascular market for the temporary occlusion of large blood vessels and expanding vascular prostheses.
Stereotaxis has entered into an agreement with Lake Region Manufacturing for the development and production of magnetically enabled guidewires for use with the Stereotaxis System, an advanced cardiology instrument control system that is designed, manufactured and marketed by Stereotaxis.
Southwestern Medical Solutions has announced that, as the final stages of development of Design 1 Labguard systems nears completion, it has already begun design analysis and discussions with manufacturing to develop its Design 2 Labguard, which will facilitate an even broader array of tests to be conducted with a single device.
Provident Healthcare Partners has announced that Market Street Medical, a subsidiary of private equity firm, Market Street Finance, completed the acquisition of iCare Medical Supply and affiliated companies.
Advanced Photometrics, a supplier of micro-infrared spectroscopy analyzers to OEMs, has changed its company name to Aspectrics as the company moves to launch its technologies into various chemical analysis and monitoring markets.
HyperBranch Medical Technology has raised $6 million in its first round of venture capital financing.
ABIOMED, a manufacturer of products for circulatory care and support, provided a clinical update for the AB5000 Circulatory Support System.
Vascular Solutions and B. Braun Medical have extended their agreement for a second contract year for the inclusion of Vascular Solutions' D-Stat Dry hemostatic bandage with B. Braun Medical's vena cava filters sold in the U.S.
Mor-Gal Plastic and The Next Phase Marketing Services (TNP-MS) closed an agreement for TNP-MS to market Mor-Gal Plastic's innovative SidePinch Clamp in North America.
The FDA approved Abbott's UroVysion DNA probe assay for use as an aid in the initial diagnosis of bladder cancer in patients with hematuria -- blood in urine -- suspected of having bladder cancer.
Global Concepts has announced that its Advance Medical Diagnostics (AMD) subsidiary had filled its first purchase order for HIV (1+2) Rapid Home Test Kits.
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