FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
Tag: defibrillators
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A New Type of Defibrillator Met Safety, Effectiveness Goals in Clinical Study
A new extravascular implantable cardioverter-defibrillator met safety and effectiveness goals for participants in a premarket clinical study.
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Officials Exploring Whether AED Drone Delivery Could Work Within U.S. EMS System
The feasibility of drone delivery for emergency medical services is becoming a more realistic proposition for healthcare systems in the U.S.
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FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
iPhone 12 Can Interfere with Pacemakers, Apple Confirms
Placing an iPhone 12 or its magnet-containing MagSafe accessories near a pacemaker can interfere with the medical device’s ability to function.
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FDA Pushes Back AED Accessory Compliance Date
FDA has changed the deadline for filing PMA applications for previously cleared AED accessories in response to the impact from COVID-19.
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Formalized AED Data Protocol May Help Make Timely Decisions
A formalized protocol to transfer AED data upon hospital arrival for cardiac arrest patients may help staff decision-making and lessen the strain on hospital resources.
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Philips Launches Pre-Hospital Wireless Monitoring Technology
Royal Philips has launched a wireless remote monitoring and defibrillator solution (Tempus ALS) for pre-hospital settings in the United States.
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FDA Lifts Injunction on Manufacture and Distribution of Philips’ Defibrillators
Philips has resumed the manufacturing and shipping of external defibrillators for the United States, following FDA notification that the injunction prohibiting those activities has been lifted.
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Defibrillators Market Growth Steady at 3.1% CAGR
The defibrillators market is forecast to reach $10.88 billion by 2022 from $9.32 billion in 2017 at a compound annual growth rate (CAGR) of 3.1%, according to market research firm ReportsnReports.
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Defibrillator Analyzer Load Bank Receives FDA 510(k) Clearance
BC Group, a company that manufactures, services, and sells biomedical testing equipment, has announced that its DA-2006-VL variable load box, an external load bank for the BC Biomedical line of defibrillator analyzers, has received FDA 510(k) clearance.