CMS and FDA Launch RAPID Pathway to Speed Access to Breakthrough Medical Devices
The new pathway aims to cut red tape and bring predictability to Medicare coverage for Breakthrough devices.
Category: Standards
Standards
Latest
Standards
Latest
AI in Diagnosis, Rural Care Gaps, and Preventable Diseases Lead ECRI’s 2026 Patient Safety Concerns
The annual report highlights risks tied to emerging technologies, access barriers, and workforce challenges that can contribute to preventable harm.
Standards
Latest
EPA Proposes Rolling Back Ethylene Oxide Emission Rules Tied to Medical Device Sterilization
The proposed amendments target Biden-era standards the agency says threatened the domestic supply of sterilized medical equipment used across health care settings.
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Do CE/HTM Professionals Lack Empathy?
Why empathy may not be the issue—and what’s actually behind communication gaps in HTM.
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Report: Medical Equipment Repair Restrictions Are Increasing Equipment Downtime and Delaying Patient Care
A new US PIRG Education Fund report finds that manufacturer-imposed barriers are hampering the work of biomeds and healthcare technology managers, with rural hospitals bearing a disproportionate burden.
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Stryker Hit by Cyberattack Linked to Iran-Tied Hacking Group, Causing Global Network Outage
The attack, attributed to pro-Palestinian hacking group Handala, reportedly wiped Windows devices across Stryker’s enterprise environment and disrupted ordering systems.
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Vermont Bill Would Give Hospitals and Independent Servicers the Right to Repair Medical Devices
H.160 would require original equipment manufacturers to provide documentation, parts, and tools needed to diagnose, maintain, and repair medical equipment on fair and reasonable terms.
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GE HealthCare Receives FDA Clearance for Diagnostic Imaging Viewer
The zero-footprint diagnostic viewer is designed to give radiologists browser-based access to imaging studies and visualization tools within the Genesis Radiology Workspace.
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FDA Recognizes AAMI CR515 for AI- and ML-enabled Device Cybersecurity
The consensus report is now on FDA’s recognized standards list, giving manufacturers a clearer reference point and hospitals another document to ask about during purchase and support discussions.
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Joint Commission Partners With STS and ACC on Outcomes-Based Cardiac Certification
The new certification will use existing clinical registry data from STS and ACC to measure patient outcomes while reducing reporting burden for hospitals.
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Joint Commission to Align Sentinel Events List With NQF Serious Reportable Events
The change, effective in 2027, is intended to simplify patient safety reporting and reduce administrative burden for healthcare organizations.
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FDA Clears GE HealthCare’s MIM LesionID Pro for Automated Tumor Burden Analysis
The AI-enabled software automates whole-body tumor burden analysis for PSMA PET/CT and SPECT/CT studies to help clinicians assess treatment eligibility and monitor response.
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FDA Clears Platform for Noninvasive Cardiac Conduction System Visualization
The CTA-based system creates a patient-specific 3D map of the cardiac conduction system to support planning and guidance during procedures such as TAVR and conduction system pacing.
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FDA Clears Single-Use Articulating Laparoscope for Minimally Invasive Surgery
The 5mm Saberscope features a 90-degree articulating tip and integrated camera designed to reduce fogging and eliminate reprocessing needs.
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