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Fdanewsdevicedailybulletin

April 8, 2005

Vol. 2 No. 70

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Boston Scientific Stent Gets FDA Direction

Boston Scientific said that the FDA approved new directions for its Taxus Express2 drug-coated coronary stent, allowing doctors to perform magnetic resonance imaging (MRI) on a patient soon after receiving the device.

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Ypsomed, Safety Syringes Announce UltraSafe Collaboration

Ypsomed, in collaboration with Safety Syringes, has designed a reusable Autoinjector specifically for use with Safety Syringes' UltraSafe Drug Delivery Systems.

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ResMed to Launch S8 Escape Flow Generator

ResMed has launched its newest CPAP device, the S8 Escape, inaugurating a new generation of high quality flow generators.

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FDA Releases Information From Mentor's Implant Application

Mentor, a supplier of medical products in the U.S. and internationally, announced that the FDA has posted information related to Mentor's silicone gel breast implant premarket approval (PMA) application on its web site.

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MIR and TMD Form Alliance to Broaden Services

Wilbur Leopold, president of MIR Preclinical Services (MIR), a Michigan-based corporation, and Sarah Bacus, founder, CEO and CSO of Targeted Molecular Diagnostics (TMD), an Illinois limited liability company, today announced the companies have formed a strategic alliance to offer greater services and cost savings to clients.

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Transoma Uses Agile PLM to Meet Regulatory Requirements

Agile Software, a provider of product lifecycle management solutions, announced that Transoma Medical, a company specializing in the use of wireless implantable sensors for monitoring vital signs in biomedical research animals, is using Agile 9 to help manage their business processes and meet compliance regulations as they develop their first medical device.

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Toshiba Releases Upgrades to the Infinix-i X-Ray System

Toshiba America Medical Systems released exclusive software upgrades (v3.5.1) for the Infinix-i series vascular and cardiac imaging system to improve the Vitrea 2 workstation.

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Fresenius Medical Gets Subpoena From U.S.

Fresenius Medical Care, a provider of kidney dialysis, got a subpoena from U.S. authorities conducting a civil and criminal probe into its relationships with doctors.

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Medtronic Renames Surgical Navigation Business

Medtronic announced that Medtronic Surgical Navigation Technologies has changed its name to Medtronic Navigation.

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MAQUET and Cardiopulmonary Announce Distribution Partnership

MAQUET and Cardiopulmonary announced a distribution partnership for the Bernoulli Ventilator Alarm System for the critical care hospital market.

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Vivascience Launches Vivapure for HIS-Tagged Protein Purification

Vivascience, a subsidiary of Sartorius AG, introduced the Vivapure 8-to-96 well cobalt-chelate kit, a complete system for simultaneous purification of multiple HIS-tagged proteins by Immobilized Metal Affinity Chromatography (IMAC).

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Firm's Stroke Treatment Begins Second Round of Tests

Tucson, Ariz.-based ImaRx Therapeutics announced the beginning of treatment for the first patient in a new Phase II clinical trial for its stroke treatment.

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Neoprobe Licenses RIGS-Related Patents

Neoprobe, a diversified developer of innovative oncology diagnostic and treatment products and cardiovascular surgical and diagnostic products, announced that it has completed a license agreement for U.S. Patent Nos. 6,418,338 and 6,760,612 B2 issued July 9, 2002 and July 6, 2004, respectively.

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