Protecting Medical Devices: Real-World Vulnerability Scenarios
Medical devices face critical cybersecurity risks but new technology and stricter regulations can protect data and device integrity.
Tag: FDA
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Masimo W1 Watch Receives FDA Clearance for Connectivity
The Masimo W1 medical watch received FDA clearance for connectivity, enabling integration with the Masimo SafetyNet telemonitoring solution.
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Baxter Recalls Life2000 Ventilator for Battery Charging Issue
Baxter is recalling the Life2000 Ventilator System due to potential battery charging dongle failure, which can prevent or hinder charging.
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Protecting Medical Devices: Real-World Vulnerability Scenarios
Medical devices face critical cybersecurity risks but new technology and stricter regulations can protect data and device integrity.
FDA Classifies Philips, Baxter, and Zoll Ventilator Recalls as Class I
Three major manufacturers—Philips Respironics, Baxter Healthcare, and Zoll Medical—have issued Class I recalls for their ventilators due to critical issues posing a risk of serious injury or death.
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FDA Clears Clarius Mobile Health OB AI Fetal Biometric Tool
Clarius Mobile Health has received U.S. FDA clearance for its OB AI tool, which uses deep learning to provide accurate fetal measurements.
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Medline Recalls Sub-G Endotracheal Tube for Choking Risk
Medline recalled the Sub-G Endotracheal Tube with Subglottic Suction due to risks of detachment, tearing, and potential airway obstruction.
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Clario Nabs FDA Clearance for SpiroSphere with Wireless ECG
Clario’s SpiroSphere platform received U.S. FDA clearance for its wireless COR-12 ECG device, consolidating spirometry and ECG data collection.
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Siemens Healthineers Biograph Trinion Receives FDA Clearance
Siemens Healthineers received FDA clearance for its Biograph Trinion PET/CT scanner, which offers improved performance and efficiency.
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OptumHealth Recalls Nimbus II Plus Infusion Pumps
OptumHealth Care Solutions is recalling Nimbus II Plus infusion pumps due to multiple failure modes, following an InfuTronix recall.
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FDA OKs InnoVoyce VYLO Laser System
InnoVoyce has received FDA 510(k) clearance for the VYLO Laser System, a 455nm blue light laser offering up to 30 watts of power.
