FDA Authorizes New Technology to Measure Heart Inflammation
The artificial intelligence platform analyzes routine coronary CT angiography to estimate patients' 10-year cardiovascular risk.
Category: Standards
Standards
Latest
Standards
Latest
FDA Clears PACS Viewer for Integrated EHR Imaging Workflows
The diagnostic imaging viewer enables clinicians to access and process medical images directly within the company's electronic health record platform, eliminating the need to switch between separate imaging and clinical systems.
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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AASM Updates Sleep Center Standard to Require Electrical Safety Inspection Rather Than Testing
The revision to the standard, effective June 1, 2026, specifies that annual electrical safety inspection by a certified electrician or biomedical engineer satisfies the equipment maintenance requirement for in-lab sleep testing programs.
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FDA Clears New Contrast Management System for Cardiovascular Procedures
The ACIST Pro Diagnostic System provides automated contrast delivery to improve efficiency and safety in cardiac catheterization labs.
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