FDAnews Device Daily Bulletin

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.

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.

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

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

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.

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.

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.

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

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.

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

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.

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.

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