• Regulatory NewsRegulatory News

    Abbott Recalls 465,000 Pacemakers for Cybersecurity Patch

    Medical device maker Abbott on Monday announced it is voluntarily recalling some 465,000 pacemakers to install a firmware update to patch cybersecurity vulnerabilities in the devices. The recall affects six pacemaker models—Accent, Accent MRI, Accent ST, Allure, Anthem and Assurity—that Abbott acquired when it completed its purchase of St. Jude Medical last January. Patients with the devices are being told to speak to their doctors to determine whether they should recei...
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    FDA Warns Abbott Device Manufacturing Plant in California

    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. The warning letter for the Sylmar, CA-based site, which manufactures implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, followed a 10-day FDA inspection in February. FDA previously issued a Form 48...
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    FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices

    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). The Merlin@home device is used to communicate with a range of St. Jude's ICDs, including its radio frequency-ena...
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    FDA Approves First PFO Occluder From St. Jude

    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. The device – which was marketed more than a decade ago under a humanitarian device exemption (HDE) but was voluntarily withdrawn by St. Jude in 2006 after FDA concluded that the target population for it was greater than 4,000 patients – is specifically for s...
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    FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest

    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. Richard Page, chair of the Department of Medicine at the University of Wisconsin School of Medicine and Public Health, currently serves as chairman of the Circulatory System Devices advisory committee, which reviews and evaluates data concerning the safety and effective...
  • Report: FDA Developing UDI Barcode System for Medical Devices

    A report in The Wall Street Journal and The Gray Sheet indicate the US Food and Drug Administration (FDA) is working to develop and roll out a Unique Device Identification (UDI) system. The policy- long in development and long held-up at the White House's Office of Management and Budget (OMB)-was mandated under the Food and Drug Administration Amendments Act (FDAAA) and is intended to standardize how medical devices are tracked. FDA has been attempting to harmo...
  • After Regulatory Issues Raised, Medtronic Plans to Heighten Postmarketing Safety Monitoring

    After a string of "headline-grabbing" recalls involving medical devices in recent months, Minneapolis-based medical device manufacturer Medtronic is announcing its intent to increase its postmarketing safety surveillance of its implantable products, reports Reuters . "The US Food and Drug Administration (FDA) alone does not have the infrastructure," said Medtronic CEO Omar Ishrak in an interview with Reuters , "so companies have to play a leading role in this." "We ne...
  • Report: Postmarketing Regulatory Troubles at St. Jude Depress Share Value

    The regulatory issues faced by St. Jude as a result of unfavorable reports concerning the safety of its Riata defibrillator leads-as well as the company's cessation of sales for its Quicksite and QuickFlex defibrillator leads-are causing more than just publicity problems for the company, reports Reuters . The regulatory issues are "raising concerns on Wall Street that doctors will curb use of the company's products, weakening its position in the $6.5 billion global mark...
  • As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance

    A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude's requests to retract an article implying defibrillator leads on St. Jude's Riata products were less safe than previously known, reports various sources. St. Jude had previously released a press release on 6 April calling on the journal to retract the article in light of what it said were "numerous mistakes and oversights," repo...
  • Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions

    The medical device industry is being shaken by a series of issues involving St. Jude Medical's defibrillator leads, reports The New York Times , leading to serious questions about transparency, adequate regulation and patient safety. The medical device leads have been implicated in a series of serious adverse events, including some where the wire contained inside the defibrillator leads have failed, leaving the wires to become exposed. The Times reports two other med...