IBM Report Finds AI-Enabled Data Breaches Cost Organizations Average of $6 Million
Malicious attacks using artificial intelligence increased 56% over the previous year, according to the 2026 Cost of a Data Breach Report.
Category: Standards
Standards
Latest
Standards
Latest
FDA Issues Early Alert for Becton Dickinson Needle Sets Following Reports of Injuries and Deaths
The agency warns of a high-risk issue where needle components may lock during insertion, potentially delaying critical care.
What Joint Commission’s AI Certification Means for HTM
As AI becomes more common across healthcare technology, the voluntary certification gives hospitals a way to demonstrate they have processes in place to govern its use.
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Masimo Receives FDA Clearance for Opioid-Induced Respiratory Depression Detection Feature
The new capability for the Radius VSM wearable monitor uses pattern-recognition technology to analyze continuous patient data and help clinicians identify early signs of opioid-related respiratory risk.
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FDA Clears New Software for Draeger Evita V800 Ventilator
The update introduces features designed to assist clinicians in managing patients with pulmonary diseases like acute respiratory distress syndrome.
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Medline Facility Fire Highlights Healthcare Supply Chain Vulnerabilities, Staritas Says
The healthcare analytics firm emphasizes the importance of prep-work and functional equivalents before supply disruptions occur.
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Safe Repair Requires Access, Not Monopoly
In a response to a recent right-to-repair op-ed, representatives of the American College of Clinical Engineering argue that giving qualified technicians access to service information, parts, and diagnostic tools can improve equipment uptime, reduce costs, and support patient care.
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US Copyright Office Opens Petitions for DMCA Exemptions
The tenth triennial proceeding allows stakeholders to seek renewals or new exemptions for bypassing technological measures that control access to protected works.
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FDA Issues Warning Letter to Zoll Medical Over Quality System Violations
The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.
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CMS Establishes New Office to Lead Health Technology and Product Strategy
The Office of Health Technology and Products will oversee digital modernization, data exchange, and artificial intelligence initiatives across federal health programs.
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Medtronic Receives FDA Clearance for Pulse Oximetry System
The new technology is designed to improve oxygen saturation monitoring reliability across diverse skin tones and patient populations.
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Siemens Healthineers Awarded $6.9 Million for Medical Device Cybersecurity Research
The project focuses on using artificial intelligence to automate security updates and protect hospital equipment from cyberattacks.
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FDA to Exempt Several Unclassified Medical Devices from Premarket Notification
New guidance identifies low-risk devices in eight medical specialties that will no longer require 510(k) submissions to reduce regulatory burdens.
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FDA Clears 3D Imaging Platform for Existing Surgical C-Arms
The CBeam system enables 3D visualization using existing hospital infrastructure during orthopedic and neurological procedures.
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