LivaNova’s Heart-Lung Machine for Cardiopulmonary Bypass Gets FDA Clearance
Medical technology company LivaNova received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz Heart-Lung Machine (HLM).
Tag: patient monitoring equipment
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Malfunctioning Integra Intracranial Monitor Was Used on Patient Who Died: FDA
The U.S. FDA has identified one patient death that was tied to the use of Integra LifeSciences CereLink ICP monitors.
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Anelto’s Video Remote Patient Monitoring Platform Improves Patient Outcomes
Remote patient monitoring solutions provider Anelto has added a video remote patient monitoring system to its product portfolio.
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LivaNova’s Heart-Lung Machine for Cardiopulmonary Bypass Gets FDA Clearance
Medical technology company LivaNova received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz Heart-Lung Machine (HLM).
Texas Power Outages Hit Counties Where People Need Electricity for Medical Devices
Power outages from harsh weather conditions are highlighting the importance of ensuring that critical medical equipment can always function properly.
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HeartBeam, LIVMOR Partner for Cloud-Based Patient Monitoring Portal
HeartBeam signed a partnership agreement with digital health solutions company LIVMOR to build a remote patient monitoring portal.
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Masimo’s Pulse Oximetry Is Not Racially Biased, According to Company Officials
Masimo’s technology showed no clinically significant bias on user ethnicity, based on data collected from black and white volunteer subjects.
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Tips for Testing Patient Monitors
Vital signs monitors frequently top the U.S. FDA’s recall list, due to their ability to cause patient harm. In fact, the FDA database includes many reports of non-invasive blood pressure failures, incorrect oxygen values, electrocardiogram (ECG) signal errors, and more. This compounds the importance of ensuring patient monitoring systems are accurate and safe to use.
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