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Fdanewsdevicedailybulletin

April 7, 2005

Vol. 2 No. 69

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FDA Clears Cyberkinetics' NeuroPort System

Cyberkinetics Neurotechnology Systems has obtained 510(k) clearances for its NeuroPort Cortical Microelectrode Array and NeuroPort Neural Signal Processor (NSP).

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Applied Biosystems Announces Developments in Two Proceedings

Applied Biosystems, an Applera business, recently announced developments in two separate legal proceedings.

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BioElectronics Announces Distribution Agreement With PD-Rx

BioElectronics, a developer of advanced, disposable, therapeutic medical devices, announced that it has entered into an agreement with PD-Rx for PD-Rx to distribute ActiPatch Therapy to physicians and healthcare providers that participate in the PD-Rx programs.

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CardioTech Announces Launch of Interventional Cardiology Start-Up

CardioTech International announced that CorNova has successfully completed its Series A financing of $3 million, enabling CorNova to continue executing its business plan.

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Xilas Gets $880,000 Grant to Advance New Device for Diabetics

Xilas Medical said that the National Institutes of Health (NIH) awarded the local company an $880,000 grant to conduct Phase II clinical trials on its TempTouch RM infrared temperature remote-monitoring device.

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International Isotopes Announces Agreement Completion With AOS

International Isotopes announced completion of a four-year Cobalt Source Recycle Agreement with Alpha-Omega Services (AOS) of Bellflower, Calif. AOS designs and develops radioactive sources and accessories for the brachytherapy market.

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Covalon Responds to FDA's Request for Further Information

Covalon Technologies announced that it has responded to the FDA's request for further information regarding the company's 510(k) premarket notification for its ColActive wound dressing.

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IMPAC Medical Systems Acquired

Sweden's Elekta AB said it completed the $250 million acquisition of Mountain View, Calif.-based IMPAC Medical Systems, following approval of the transaction by IMPAC's stockholders.

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ThermoGenesis to Supply Thrombin Kits to Biomet

ThermoGenesis announced that the company and Biomet reached agreement for the company to supply Biomet's subsidiary, Cell Factor Technologies, with disposable kits that produce stable, activated thrombin from the patients own blood in less than 30 minutes.

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Criticare Announces Introduction of Veris MRI

Criticare Systems announced the introduction of the Veris MRI monitoring system, a joint development effort of MEDRAD and Criticare.

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Fisher Scientific Completes Sale of Atos Medical

Fisher Scientific International completed its sale of Atos Medical AB, a manufacturer of ear, nose and throat medical devices with 2004 sales totaling $35 million, to Nordic Capital for $110 million in cash.

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Gen-Probe Prevails in Arbitration With Bayer

Gen-Probe announced that it has received a tentative award in its arbitration with Bayer HealthCare concerning the parties' collaboration for the development and sale of nucleic acid diagnostic tests for viral organisms.

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