FDA Issues Warning Letter to Zoll Medical Over Quality System Violations
The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.
Tag: defibrillators
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Mindray Unveils BeneHeart Defibrillator Technology
The new defibrillators offer comprehensive diagnosis and monitoring tools, and introduce a whole-process quality improvement solution, according to Mindray.
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ASSURE Wearable Cardioverter Defibrillator System Demonstrates Low False Alarm Rates
Kestra Medical Technologies’ ASSURE WCD system is effective at reducing false-positive shock alarms, according to clinical evaluation results.
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FDA Issues Warning Letter to Zoll Medical Over Quality System Violations
The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.
Kestra Medical Technologies Nabs FDA Premarket Approval for Wearable Cardioverter Defibrillator
Kirkland, Wash.-based KestraMedical Technologies, Inc., announces that it has received U.S. FDA Premarket Approval for the ASSURE wearable cardioverter defibrillator system, which monitors and treats patients at risk of sudden cardiac death.
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St. Jude Agrees to Pay $27M for Allegedly Selling Defective Heart Devices
The government alleges that St. Jude failed to disclose serious adverse health events in connection with the premature depletion of the battery in certain models of its implantable defibrillators.
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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.
