AAMI Updates Steam Sterilizer Standard for Medical Device Manufacturers
The revised ANSI/AAMI ST8:2026 standard adds new testing requirements, updates terminology, and revises manufacturer instructions for hospital steam sterilization systems.
Category: Standards
Standards
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Standards
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Masimo Receives FDA Clearance for Opioid-Induced Respiratory Depression Detection Feature
The new capability for the Radius VSM wearable monitor uses pattern-recognition technology to analyze continuous patient data and help clinicians identify early signs of opioid-related respiratory risk.
Standards
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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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Can Feedback Help CE/HTM Get Well-deserved Recognition?
Past equipment performance and maintenance experience can provide valuable feedback for future technology decisions while strengthening recognition of CE and HTM expertise.
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FDA Clears Six Siemens Healthineers Interventional Imaging Systems with AI
The new Artis portfolio features an AI-powered imaging chain designed to improve image quality and noise reduction during interventional procedures.
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ECRI Urges Congress to Strengthen Oversight of Digital Health Tools
The patient safety organization highlights risks associated with unvalidated wellness devices and lack of transparency in clinical decision support software.
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FDA OKs AI Early Warning System for Hospital Sepsis Detection
The technology, developed by Johns Hopkins University researchers, identifies sepsis cases up to 48 hours earlier than traditional methods and has reduced mortality rates by 18%.
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FDA Clears New Features for Portable Liver and Spleen Ultrasound System
The updates include a new spleen exam workflow, compatibility with Apple laptops, and direct connection to electronic health records.
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