Fdanewsdevicedailybulletin

Feb. 11, 2005

Vol. 2 No. 30

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FDA Extends STED Pilot Program Until July 2006

The FDA's Center for Devices and Radiological Health has extended its pilot program for evaluating globally harmonized medical device premarket applications, accepting submissions in this format until July 2006.

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Distribution of Powerheart AEDs Begins to U.S. Hospitals

Cardiac Science has announced that GE Healthcare initiated marketing and distribution of Cardiac Science's line of Powerheart-branded automated external defibrillators (AEDs) and fully automatic, in-hospital defibrillator-monitors (CRMs) to hospitals in the U.S. and Canada.

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LeMaitre Vascular Acquires Endomed

LeMaitre Vascular has acquired Endomed, a maker of endovascular stent grafts for the minimally invasive treatment of thoracic and abdominal aortic aneurysms.

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Delphi Adds to Its Global Distribution Network for IVantage

Delphi Medical Systems has signed an exclusive distribution agreement for the U.S. for its IVantage infusion pumps, accessories and disposables with Progressive Medical.

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Vascular Concepts' Stent Undergoing Clinical Trials

Away from the global attention on Indian drug companies, fledgling Bangalore-based medical devices company Vascular Concepts is undertaking the clinical trial of its innovative stent, coated with a combination of two drugs.

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Cytyc Buys Ga.-Based Proxima for $160 Million

Women's health product maker Cytyc paid $160 million in cash to acquire Proxima Therapeutics, a Georgia-based maker of radiation systems for treating cancer.

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Sequenom Announces Resignation of CEO Schuh

Sequenom has announced that Antonius Schuh resigned from his position as the company's president and chief executive officer and a member of the company's board of directors by mutual agreement with the board.

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Bio-Matrix Submitting Patents for Stem Cell, Tissue Devices

Bio-Matrix Scientific is in the process of submitting its first set of patents on its medical devices.

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ZOLL Introduces New AED Product for Professional Rescuers

ZOLL Medical, a manufacturer of resuscitation devices and software solutions, has expanded its line of automated external defibrillators (AEDs) with the introduction of the ZOLL AED Pro.

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BioElectronics Announces Formation of Surgery, Wound Care Group

BioElectronics is a developer and marketer of advanced, inexpensive, FDA- and European Union-cleared, disposable, drug-free, medical devices.

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R2 Signs Sole Source Agreement With FirstChoice

R2 Technology, a maker of medical computer aided detection (CAD), has announced a new contract designating R2 Technology as a provider of CAD systems as an aid to radiologists for the earlier detection of breast cancer.

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Qiagen Announces Supply Agreement With Roche

Qiagen has entered into a manufacturing and supply agreement with Roche Molecular Systems, Pleasanton , Calif., a unit of Roche Diagnostics Basel, Switzerland, who will market Qiagen's media sample preparation kits under their AmpliLute trademark.

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Swedish Cancer Institute Adds Groundbreaking Technology

The Swedish Cancer Institute will sign a strategic partnership and technology-applications agreement with medical-technology leader Elekta for Elekta Synergy.

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