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  • Regulatory NewsRegulatory News

    ICD and Pacemaker Ecosystems Vulnerable to Hacks: Report

    Cybersecurity firm WhiteScope says it has identified cybersecurity vulnerabilities in the device ecosystems for pacemakers and implantable cardioverter-defibrillators (ICDs) across four major vendors. Background In recent years, the US Food and Drug Administration (FDA) has advanced efforts to improve medical device cybersecurity, and has held three public workshops and issued two final guidances detailing device makers' pre- and postmarket cybersecurity responsibilitie...
  • Regulatory NewsRegulatory News

    MHRA Releases Recommendations for Leadless Pacemakers

    The UK's Medicines and Healthcare products Regulatory Agency's expert advisory group on leadless cardiac devices has released its initial recommendations for pre- and postmarket clinical studies for leadless pacemakers. According to MHRA, leadless pacemakers, which do not rely on wired leads to deliver a signal to the heart, have the potential to significantly benefit patients, as the most common adverse events caused by implanted cardiac devices involve the leads. "The...
  • Regulatory NewsRegulatory News

    FDA Down-Classifies External Pacemaker Pulse Generator Devices and PSAs

    The Food and Drug Administration (FDA) on Friday released a final order to reclassify external pacemaker pulse generator (EPPG) devices and pacing system analyzers (PSAs), which are currently class III devices, into class II (special controls). The final order also creates a separate classification regulation for PSAs and places single- and dual-chamber PSAs, which are currently classified with EPPG devices, and triple-chamber PSAs (TCPSAs), which are currently post-ame...
  • Regulatory NewsRegulatory News

    Australia’s TGA Cites Medical Device Batteries as a Growing Concern

    Australia’s Therapeutic Goods Administration (TGA) is calling attention to medical device battery issues, particularly for implantable devices, and saying manufacturers and health facilities should adopt procedures to reduce risk. A battery-related problem was listed as a potential contributing factor in more than 50 adverse event reports over the past 10 years involving deaths or serious injuries, the Australian regulator said, noting a range of safety alerts over the p...