ICD and Pacemaker Ecosystems Vulnerable to Hacks: Report
By Michael Mezher -
Published 05 June 2017
Cybersecurity firm WhiteScope says it has identified cybersecurity vulnerabilities in the device ecosystems for pacemakers and implantable cardioverter-defibrillators (ICDs) across four major vendors.
Categories: News, US, FDA, Medical Devices, Postmarket surveillance
Tags: Cybersecurity, Pacemakers, ICDs, Billy Rios, WhiteScope, DHS ICS-CERT
FDA Warns Abbott Device Manufacturing Plant in California
By Zachary Brennan -
Published 13 April 2017
The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design verification and design validation.
Categories: News, US, FDA, Due Diligence, Medical Devices, Quality
Tags: warning letter, Abbott, St. Jude Medical, ICDs, CRT-Ds