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Fdanewsdevicedailybulletin

Feb. 2, 2005

Vol. 2 No. 23

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FDA Issues Alert for Preloaded Syringes

The FDA has issued a nationwide alert against the use of all IV Flush brand preloaded syringes containing either heparin or sodium chloride because the products have not received proper clearance and may be contaminated.

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WorldHeart Buys MedQuest Products

WorldHeart has signed a definitive agreement to acquire all of the assets of MedQuest Products, subject to certain approvals, consents and conditions.

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Spire Receives NSF Grant to Develop Blood-Compatible Catheters

Spire has announced the receipt of a two-year SBIR Phase II grant of $498,764 from the National Science Foundation to continue the development of blood-compatible dialysis catheters, used for the treatment of end-stage renal disease dialysis patients.

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Infectech Registers Identikit Test Kits With FDA

Infectech has received notification from the FDA's Center for Devices and Radiological Health of registration of the company and its initial product line for biophasic system devices.

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Angiotech Announces Joint Lawsuit Against Conor Medsystems

Angiotech Pharmaceuticals has announced that it, along with corporate partner Boston Scientific, has initiated legal proceedings in the Netherlands against Conor Medsystems.

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Healthcare Start-Up ETView Launches $1.5 Million Funding Round

Healthcare start-up ETView plans to raise $1.5 million. New York-based investment bank Burnham Securities will lead the funding round.

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Southwestern Advancing Designs for Carotid Endarterectomy Shunt

Southwestern Medical Solutions has announced that the company's design team has begun to advance the technical elements for a carotid endarterectomy shunt.

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FlowMedica Announces Study of Its Benephit Infusion System

FlowMedica, a medical device company developing intravascular systems for treating renal dysfunction related to cardiovascular diseases, has announced Scripps Clinic's initiation of a physician-directed clinical study of its FlowMedica Benephit Infusion System in patients with compromised kidney function who are undergoing coronary procedures.

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IOMAI Receives $2.9 Million Grant From NIH for Patch Technology

IOMAI, a private biopharmaceutical company, has announced the award of a $2.9 million grant from NIH to help develop a patch that is designed to improve responses to influenza vaccination.

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Aspect Medical Extends Distribution Deal

Aspect Medical Systems has extended a distribution agreement with Boston Scientific because further studies are needed to assess the use of its technology, which monitors patients' consciousness during surgery, in less-invasive procedures.

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Gebauer Announces Formation of New Business Unit

Gebauer, a 106-year-old medical device manufacturer and marketer of topical anesthetic skin refrigerants, has announced the formation of a new business unit, the Medical Device Development and Contract Manufacturing Group.

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Micro Therapeutics Receives $3.7 Million Payment

Micro Therapeutics (MTI) has received a $3.7 million payment resulting from the acquisition of certain assets of Genyx Medical, a company in which MTI held a minority equity interest, by C. R. Bard.

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Tecan Exhibits Cavro XLP6000, Cavro XCalibur Syringe Pumps

Tecan has exhibited new, Cavro-brand, OEM liquid handling components at Lab Automation 2005.

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