FDA Clears Avatar Medical Vision for 3D Imaging and Surgical Planning
The software supports CT and MR image visualization across standard displays, glasses-free 3D systems, and virtual reality environments.
Category: Standards
Standards
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Standards
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FDA Clears Philips AI-Powered Spectral CT Imaging System
The system uses artificial intelligence for image reconstruction to improve diagnostic precision and workflow efficiency in radiology, cardiology, and oncology.
MARS Bioimaging Gains FDA Clearance for Portable Photon-Counting CT Scanner
The extremity-focused system is designed for point-of-care use, including clinics and ambulatory settings.
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Could Vermont Crack the Code on Right to Repair? (Editor’s Message)
A recent hearing in Vermont shows lawmakers are asking more pointed questions about medical device repair. What happens next may depend on whether HTM professionals speak up.
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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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