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FDA enters consent decree with Medtronic, Inc.

May 21, 2015 By MedNews Leave a Comment

The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. [Read more…]

Filed Under: FDA News & Alerts Tagged With: cancer, Medtronic, Pain Management, S. Omar Ishrak, Synchromed II Implantable Infusion Pump Systems, Thomas M. Tefft

New Pacemaker Can Be Used Safely During MRI Exams

February 8, 2011 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods. [Read more…]

Filed Under: FDA News & Alerts, Heart Attack Tagged With: Inc., Medtronic, pacemaker, SureScan Pacing System

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