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.
Category: Standards
Standards
Latest
Standards
Latest
New FDA-Approved Therapy Brings At-Home Electrical Field Treatment to Pancreatic Cancer Care
The wearable system uses alternating electrical fields to disrupt cancer cell division and can be used continuously during daily activities.
Standards
Latest
Baxter Removes Sigma Spectrum Infusion System Platforms
The removal is tied to incorrect software installations that could result in inaccurate flow rates and user confusion during clinical use.
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Most Healthcare Organizations Report Operational or Clinical Impact From Cyber Threats
More than 70% of respondents reported financial, operational, or clinical impacts from cyber incidents, according to a recent survey.
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Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking
The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.
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ECRI Leaders Share System-Level Falls Prevention Insights at National Patient Safety Meeting
ECRI leaders discussed how technologies such as AI-based monitoring and safety systems can affect falls prevention and why system-level evaluation is critical to avoid unintended risk.
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FDA Flags Recall Involving IMRIS MRI Systems Linked to Siemens 3T Magnet Issue
The recall affects IMPRIS Neuro III-SV models that use Siemens 3T magnets, citing a risk of blocked helium venting during a magnet quench.
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FDA Issues Recall Early Alert for Olympus Single-Use Ligating Devices
Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention.
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BD Advises Biomed Inspection of Dropped Alaris Pump Modules
The company advises taking any dropped or severely jarred modules out of service and sending them to biomedical engineering for inspection before reuse.
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Coalition Urges HHS to Withdraw Proposed HIPAA Security Rule
More than 100 healthcare organizations are calling on HHS to withdraw the proposed HIPAA Security Rule update and pursue a collaborative approach to cybersecurity standards.
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FDA Clears for Augmented Reality Navigation Platform for Neurosurgery
The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.Â
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FDA to Accept De-identified Data for Certain Medical Devices Submissions
New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.Â
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Survey Reveals Disconnect Between Hospital Cybersecurity Goals and IoMT Device Risk Management Practices
43% of hospital security leaders name IoMT visibility as their top cybersecurity challenge, while internal process issues create the biggest obstacle to effective risk management.
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Advocacy Group Renews Push for Medical Right to Repair
US PIRG is surveying HTM professionals to document how repair restrictions affect patient care, downtime, and costs.
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