FDA Issues Early Alert for Becton Dickinson Needle Sets Following Reports of Injuries and Deaths
The agency warns of a high-risk issue where needle components may lock during insertion, potentially delaying critical care.
Category: Standards
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Fresenius Kabi Issues Correction for Ivenix Infusion Pumps Following Impact Damage
The Food and Drug Administration classifies the recall as the most serious type after reports of touchscreen malfunctions caused by dropped or jarred devices.
Siemens Healthineers Awarded $6.9 Million for Medical Device Cybersecurity Research
The project focuses on using artificial intelligence to automate security updates and protect hospital equipment from cyberattacks.
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FDA to Exempt Several Unclassified Medical Devices from Premarket Notification
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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FDA Clears 3D Imaging Platform for Existing Surgical C-Arms
The CBeam system enables 3D visualization using existing hospital infrastructure during orthopedic and neurological procedures.
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FDA Clears New AI Tool for Cardiac Ultrasound Assessments
The tool from Clarius Mobile Health automates heart function measurements to assist clinicians in primary care and emergency settings.
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Philips Adds AI Measurement and Lesion Classification Tools to Ultrasound Systems
The FDA-cleared update automates measurement tasks and provides clinical decision support to improve imaging workflow.
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Joint Commission Releases Voluntary Responsible Use of AI in Healthcare Certification
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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Senator Requests FDA Investigation Into Chinese Medical Device Cybersecurity
The request seeks a review of devices cleared before 2023 to protect patient data from potential foreign interference.
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Advanced Global Health Starts with Safe Medical Device Repairs
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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AI System for Predictive Burn Wound Assessment Receives FDA De Novo Clearance
The system utilizes multispectral imaging and algorithms to help clinicians determine the healing potential of burn wounds.
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React Health Removes VOCSN V+Pro Ventilators
A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.
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Medical Device Recalls Declined in Q1 2026 Amid FDA Quality System Changes
Sedgwick’s latest report shows fewer medical device recall events in Q1 2026, while sterility-related recalls drove the majority of impacted units.
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FDA Issues Alert for Draeger Atlan Anesthesia Workstations
Draeger expands its correction for Atlan models due to potential mechanical ventilation failure.
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