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Center for Devices and Radiological Health

FDA approves first subcutaneous heart defibrillator

Monday, October 1, 2012 11:51 AM

The FDA has approved Cameron Health’s subcutaneous implantable defibrillator (S-ICD) system, a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted subcutaneously instead of connected directly into the heart.

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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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