The nationwide recall affects Hudson RCI neonatal and infant heated wire breathing circuits following reports of melting, smoke, and localized thermal damage at the humidifier connector.
A joint advisory from CISA, the FBI, the NSA, and international partners urges healthcare organizations to secure vulnerable networking devices against Russian state-sponsored actors.
The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.
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The Office of Health Technology and Products will oversee digital modernization, data exchange, and artificial intelligence initiatives across federal health programs.
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The new technology is designed to improve oxygen saturation monitoring reliability across diverse skin tones and patient populations.
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The project focuses on using artificial intelligence to automate security updates and protect hospital equipment from cyberattacks.
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New guidance identifies low-risk devices in eight medical specialties that will no longer require 510(k) submissions to reduce regulatory burdens.
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The CBeam system enables 3D visualization using existing hospital infrastructure during orthopedic and neurological procedures.
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The tool from Clarius Mobile Health automates heart function measurements to assist clinicians in primary care and emergency settings.
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The FDA-cleared update automates measurement tasks and provides clinical decision support to improve imaging workflow.
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Following initial guidance in 2025, the new certification will recognize US healthcare organizations and health systems adopting and implementing the technology responsibly.
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The request seeks a review of devices cleared before 2023 to protect patient data from potential foreign interference.
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A HIMSS Foundation executive argues that expanding right-to-repair policies to healthcare could create patient safety and cybersecurity risks tied to medical device repair.
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The system utilizes multispectral imaging and algorithms to help clinicians determine the healing potential of burn wounds.
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