FDAnews Device Daily Bulletin

Medtronic has obtained CE Mark approval on its Valiant Thoracic Stent Graft with Xcelerant Delivery System for commercial release in Europe.

Stratagene, a developer, manufacturer and marketer of specialized life science research and diagnostic products, announced that its wholly owned subsidiary, Hycor Biomedical, has received clearance from the FDA to market its Anti-Tissue Transglutaminase (tTG) IgG (Immunoglobulin G) autoimmune test in the U.S.

Ev3, a privately held endovascular medical device company, has received approval to include the SpideRX Embolic Protection Device in the second arm of the company's carotid clinical trial.

Andromed has initiated its clinical validation study on Androflo, a noninvasive diagnostic tool allowing the continuous real-time measurement of respiratory rate.

Molecular Devices announced the introduction of its third IMAP Substrate Finder for kinases, following the launch of its first two in 2004.

Quantum Dot announced the launch of the Mosaic Gene Expression Assay System.

Micro Dynamics (MDC), a provider of electronic contract manufacturing services (EMS), announced its Eden Prairie, Minn., facility has achieved ISO 13485:2003 certification.

SurModics, a provider of surface modification and drug delivery technologies to the healthcare industry, announced that its board of directors has elected Bruce Barclay to the position of president and CEO, effective July 1.

Merlyn Associates has announced the introduction of four additional products to their innovative EndoFlex line, which features endotracheal tubes with a patented adjustable distal tip.

ParAllele BioScience has announced the issuance by the U.S. Patent Office of a key patent (6,858,412) covering its Molecular Inversion Probe (MIP) technology.

MedCap announced that the AccuScan Drugs of Abuse have received Health Canada manufacturers' certificate to cover the export of medical devices.

HealthSouth completed a $715 million refinancing arrangement that the company's chief executive called "another significant step" toward rectifying 18 months of fraud-related issues.

ThromboScience, a provider of blood tests that determine cardiovascular risk, announced that it has measured a new risk factor that strongly predicts complications from heart disease in patients who have had coronary artery stenting.

Southwestern Medical Solutions announced that it has contracted the firm Instant Diagnostics to conduct final scientific support data studies on its Labguard product line.