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.
Tag: medical devices
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AI and the New Operating System of Healthcare
The technology is no longer a standalone tool, but connective tissue linking devices, data, and clinical workflows.
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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.
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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.
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.
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RSNA 2025: New Imaging Technologies Take Center Stage
From advanced scanners to adaptive AI workflows, RSNA 2025 exhibitors debuted imaging tools aimed at personalizing care and improving efficiency.
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HSCC Releases Updated Guidance on Model Contract Language for Medtech Cybersecurity
New guidance aims to clarify cybersecurity roles and expectations between health delivery organizations and medical device manufacturers.
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Philips Debuts AI Tool to Guide Mitral Valve Repair Devices in Real Time
The tool automatically tracks transcatheter repair devices and merges echo and X-ray for clearer intra-procedural guidance.
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Medcrypt Launches Platform to Support Cybersecurity Compliance for Device Manufacturers
The software is intended to help manufacturers demonstrate cybersecurity maturity as expectations from regulators and hospital purchasers continue to rise.
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FDA Clears AI Tool for Coronary Plaque Analysis
The clearance enables on-premise AI analysis of coronary CT angiography for quantifying calcified and non-calcified plaque.
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US Clinical Study for Robotic Microsurgery System Begins Patient Enrollment
The postmarket trial is designed to evaluate the performance of a surgical robotic system in free flap reconstruction and lymphatic repair procedures.
