East To Meet West On Cardiovascular Clinical Trial Design
This article was originally published in The Gray Sheet
Executive Summary
FDA and Japanese regulatory authorities will meet in January to discuss a project for establishing "global" cardiovascular device clinical studies capable of satisfying approval requirements in both countries
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Novasys Medical CEO: Renessa non-surgical stress urinary incontinence device maker tapped Scott Cramer as its new CEO last week to replace the departing Debra Reisenthel. Cramer was formerly CEO of peripheral vascular device firm Bacchus Vascular, which Covidien acquired in 2009. Prior to Bacchus, Cramer was a senior VP with varicose vein treatment firm VNUS Medical Technologies, which was also purchased by Covidien last year (1"The Gray Sheet" May 11, 2009). Reisenthel was a nine-year veteran of Novasys. She is pursuing a "position where I can use my leadership and fundraising skills to 'make a difference' and improve people's lives," she says
People In Brief
Novasys Medical CEO: Renessa non-surgical stress urinary incontinence device maker tapped Scott Cramer as its new CEO last week to replace the departing Debra Reisenthel. Cramer was formerly CEO of peripheral vascular device firm Bacchus Vascular, which Covidien acquired in 2009. Prior to Bacchus, Cramer was a senior VP with varicose vein treatment firm VNUS Medical Technologies, which was also purchased by Covidien last year (1"The Gray Sheet" May 11, 2009). Reisenthel was a nine-year veteran of Novasys. She is pursuing a "position where I can use my leadership and fundraising skills to 'make a difference' and improve people's lives," she says
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Europe, United States, Japan: For medical device companies seeking an international market, this is a well-trod path