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Emerging Israeli cardiovascular firms demonstrate innovation.
August 1, 2005... Emerging Israeli cardiovascular firms demonstrate innovation
By JEFFREY BERG, PhD
CDU Contributing Editor
Israel has been a source of innovative medical products in a wide range of medical specialties, including many for...
DES presentations lead late-breaking clinical trials sessions.(drug-eluting stents)
August 1, 2005... DES presentations lead late-breaking clinical trials sessions
By HOLLAND JOHNSON
CDU Associate Managing Editor
PARIS - A majority of the estimated 10,000 attendees crammed into the Palais de Congres for the EuroPCR 2005 meeting in...
'Surprised' by panel votes, two firms remain optimistic.(Acorn Cardiovascular and Abiomed on decision by Circulatory Systems Devices Panel)
August 1, 2005... 'Surprised' by panel votes, two firms remain optimistic
By CHRISTOPHER DELPORTE
CDU Washington Editor
WASHINGTON - Negative decisions by the FDA's Circulatory System Devices Panel vote in late June left officials at two...
Probe, recalls may impact J&J's planned purchase of Guidant.(Johnson and Johnson)
August 1, 2005... Probe, recalls may impact J&J's planned purchase of Guidant
By DON LONG
CDU Managing Editor
The possibility for a smooth and easy merger of Guidant (Indianapolis) into healthcare power Johnson & Johnson (New Brunswick, New...
International report.(Occam International receives European approval for drug-eluting stent)(Cardiac Science receives regulatory approval in China to sell automatic external defibrillators)(NMT Medical receives approval of UK clinical study for BioSTAR patent foramen ovale)
August 1, 2005... International report
Biosensors unit gets CE mark for DES
A CDU Staff Report
Biosensors International (Singapore) said last month that its European subsidiary, Occam International (Eindhoven, the Netherlands), has received CE mark...
Acquisitions.(ATS Medical partnership with Genesee BioMedical)(CardioTech International will not acquire CarTika Medical)(Quinton Cardiology Systems' merger with Cardiac Science)
August 1, 2005... Acquisitions
* ATS Medical (Minneapolis) has entered into a partnership with privately held Genesee BioMedical (Denver) to develop and manufacture a line of heart valve annuloplasty rings for use by surgeons for repair of damaged heart...
Business Developments.(ev3 product development)(Boston Scientific acquisition costs)(Johnson and Johnson Q2 results)
August 1, 2005... Business Developments
ev3 no longer mum on its prospects
Emerging from a Securities and Exchange Commission-mandated "quiet period" last month - and on the heels of its $165 million IPO in June - endovascular technology developer ev3...
Agreements.(ATS Medical in marketing agreement with Regeneration Technologies-Cardiovascular)(Wampole Laboratories agreement with Roche Diagnostics)(MediVas and Estracure sign contract for drug delivery technology)
August 1, 2005... Agreements
* ATS Medical (Minneapolis), which offers products and services focused on cardiac surgery, reported entering into an exclusive marketing services agreement with Regeneration Technologies-Cardiovascular (formerly Alabama Tissue...
Market Updates.(dealing with rising costs of Medical Device User Fee and Modernization Act)(Steven Ubl to head Advanced Medical Technology Association)(Lester Crawford named FDA commissioner)
August 1, 2005... Market Updates
Senate offers plan on FDA user fees
A Senate committee last month took a step forward in addressing the rising costs associated with the Medical Device User Fee and Modernization Act (MDUFMA), which have been a concern...
Personnel File.(Jim Bullock president and CEO of Atritech)(Robert Palardy resigns at Cambridge Heart)(Stephen Grant joins Celladon)
August 1, 2005... Personnel File
* Jim Bullock has been named president and CEO of Atritech (Minneapolis). Bullock, previously an entrepreneur-in-residence for Split Rock Partners, also has recently served as president and CEO of Endocardial Solutions....
Product Pipeline.(approval for Jarvik Heart ventricular assist device)(Biotronik receives FDA approval to market Protos CLS )(Brazil's first paclitaxel-coated stent to treat peripheral arterial disease implanted)
August 1, 2005... Product Pipeline
Jarvik Heart gets okay for VAD trial
Another company has taken a step toward U.S. approval for a ventricular assist device (VAD), reporting FDA approval for its pivotal trial. Jarvik Heart (New York) - the company...