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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January 19

Roche takes $1B majority stake in Foundation Medicine to use genomic testing to personalize oncology treatments

BRANY launches software, iPad app to streamline protocol creation for investigator-initiated trials

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January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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