MITRE Report Outlines Cybersecurity Risks for Medical Devices Using AI and Cloud
The analysis identifies emerging threats to patient safety and device performance as manufacturers adopt new technologies and advanced encryption.
Category: Standards
Standards
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Standards
Latest
US and UK Regulators Strengthen Cooperation on Medical Device Approvals
The partnership between the Food and Drug Administration and the Medicines and Healthcare products Regulatory Agency aims to streamline technology access and reduce regulatory duplication.
GE HealthCare’s Photonova Spectra Photon-counting CT Receives FDA Clearance
The cleared system introduces photon-counting CT designed to capture spectral data in a single scan and reduce protocol complexity.
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Defibrillation Lead Wins FDA Approval for Conduction System Pacing
The defibrillation lead, approved for placement in the left bundle branch area, can deliver both life-saving shock therapy and physiologic pacing through the heart’s natural electrical system.
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CISA Issues Alert on Endpoint Management System Security After Stryker Cyberattack
Federal agency calls on healthcare and medical technology organizations to tighten endpoint management controls following attack on Stryker’s Microsoft environment.
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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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