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.
Category: Standards
Standards
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Standards
Latest
What 2025’s Healthcare Breaches Taught Us and Why 2026 Raises the Stakes
Lessons from 2025’s breaches point to a tougher reality in 2026, as AI adoption accelerates and cybersecurity becomes inseparable from patient care.
Standards
Latest
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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What HTM Needs to Know About The Joint Commission’s New Accreditation Model
As Accreditation 360 rolls out in January 2026, the Joint Commission explains what’s changing, what isn’t, and how HTM teams can prepare.
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GE HeathCare Recalls Carestation Anesthesia Systems Due to Shutdown Risk
GE HealthCare is updating use instructions after reports certain systems may not switch to battery mode during AC power loss, potentially disrupting ventilation and agent delivery.
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HSCC’s AI Cyber Guidance Is a Map. HTM Pros Are the Guides (Editor’s Message)
New AI cybersecurity guidance is set to roll out in early 2026, as AI becomes more embedded in healthcare technology.
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Congress Removes Military Right to Repair Provisions from Defense Bill
Bipartisan provisions that would have expanded military access to repair data and technical information were removed from the final FY26 defense authorization bill.
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FDA Launches Digital Health Pilot for Chronic Disease Technologies
The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.
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Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue
The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.
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