FDAnews Device Daily Bulletin
April 8, 2005 | Vol. 2 No. 70
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.
Ypsomed, in collaboration with Safety Syringes, has designed a reusable Autoinjector specifically for use with Safety Syringes' UltraSafe Drug Delivery Systems.
ResMed has launched its newest CPAP device, the S8 Escape, inaugurating a new generation of high quality flow generators.
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.
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.
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.
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.
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.
Medtronic announced that Medtronic Surgical Navigation Technologies has changed its name to Medtronic Navigation.
MAQUET and Cardiopulmonary announced a distribution partnership for the Bernoulli Ventilator Alarm System for the critical care hospital market.
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).
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.
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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