Search Results for St. Jude Medical

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FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices By Michael Mezher - Published 11 January 2017

The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs).

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, Medical Device Cybersecurity, St. Jude Medical, MedSec, Muddy Waters Research, Merlin@home Transmitter

FDA Approves First PFO Occluder From St. Jude By Zachary Brennan - Published 28 October 2016

The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who previously had a stroke.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: PFO Occluder, St. Jude Medical, FDA device approval

FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest By Zachary Brennan - Published 09 May 2016

The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest.

Categories: News, US, CDRH, Clinical, Crisis management, Medical Devices, Regulatory intelligence

Tags: medical device panel, St. Jude Medical, Amplatzer, PFO Occluder, FDA advisory committee, conflict of interest

Report: FDA Developing UDI Barcode System for Medical Devices By Alexander Gaffney - Published 26 April 2012

Categories: FDA, CDRH

Tags: St. Jude Medical, Medtronic, UDI, UID, OMB, Latest News, Boston scientific, medical device