Fresenius Kabi Ivenix LVP Software Update to Address Issues
Fresenius Kabi advises updating Ivenix Infusion System software to avoid two anomalies risking under- or over-infusion.
Tag: FDA
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FDA OKs Inogen Simeox 200 Airway Clearance Device
The Inogen Simeox 200 Airway Clearance Device aids bronchial drainage in patients with chronic respiratory conditions using high-frequency oscillatory vibrations and intermittent negative pressure.
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LifeSignals UbiqVue 2A Monitoring System Earns FDA Clearance
LifeSignals’ UbiqVue 2A Multiparameter System wireless patient monitoring wearable has received FDA Class II 510(k) clearance.
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Fresenius Kabi Ivenix LVP Software Update to Address Issues
Fresenius Kabi advises updating Ivenix Infusion System software to avoid two anomalies risking under- or over-infusion.
Quest Expands Field Corrective Action Services for OEMs
Quest International has expanded its FCA services, offering medical device OEMs scalable solutions for regulatory compliance.
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Phasitron 5 Breathing Circuits Recalled for Nickel Coating Issue
Percussionaire is recalling Phasitron 5 breathing circuits due to a nickel coating issue that may aerosolize nickel and pose health risks. Customers are advised to dispose of or return affected products, with specific short-term use guidelines for necessary situations.
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FDA Clears Zeta Navigation System for Expanded Use
Zeta Surgical’s Zeta Navigation System has received FDA clearance for expanded instruments and enhanced hospital connectivity.
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GE HealthCare Updates EVair Compressor Recall for Ventilator Use
GE HealthCare has issued an update to the EVair Compressor recall, with testing results confirming safe usage across all patient groups.
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Paragonix Gets FDA Clearance for KidneyVault Perfusion Device
Paragonix Technologies received FDA 510(k) clearance for KidneyVault, a portable kidney preservation device with digital monitoring.
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REMI Vigilenz AI EEG Notifications Earn FDA Clearance
Epitel’s REMI Vigilenz AI For Bedside Notifications has received FDA 510(k) clearance, notifying clinicians of potential seizures.
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Michelle Tarver Officially Named Director of FDA’s CRDH
Michelle Tarver, PhD, MD, has been appointed director of the FDA's Center for Devices and Radiological Health (CDRH), bringing over 15 years of experience in medical device regulation, public health, clinical research, and policy development.
