Tag: medical devices

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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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When a Patch Becomes a Problem: Hidden Risks in ‘Smart’ Medical Devices

Blindly deploying vendor patches can sideline critical devices and jeopardize patient safety.

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FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

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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.

Getting Stakeholder Input Right in Infusion System Development

Jul 21, 2025

Effective stakeholder analysis and requirements gathering are critical to safe, compliant infusion system design.

FDA Clears Siemens’ New Two-in-One Radiography/Fluoroscopy Platforms

Jul 21, 2025

The platforms, which switch between radiography and fluoroscopy applications, enable remote and tableside exams and feature AI-powered workflows.

SunMed Holdings Removes Adult Manual Resuscitator Devices

Jul 18, 2025

The Class I recall involves devices with incorrectly assembled B/V filters.

BD Recalls Certain Alaris Pump Infusion Sets Over Accuracy Issues

Jul 15, 2025

Use with select infusion sets may lead to over- or under-infusion, bolus inaccuracies, and alarm delays, BD warns in recall notice.

FDA Clears Home Airway Clearance System That Syncs Breathing with Chest Compressions

Jul 10, 2025

The FDA has cleared a new home airway clearance system that synchronizes breathing with chest compressions to support patients with chronic lung diseases such as COPD, cystic fibrosis, and bronchiectasis.

AAMI Aligns with National Academy of Medicine AI Code of Conduct

Jul 7, 2025

AAMI intends to leverage the code to inform its work addressing the use of AI and machine learning in medical devices.

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3D Imaging Tool for Ultrasound Gains FDA Clearance

The system allows US healthcare providers to transform traditional 2D ultrasound into AI-supported 3D tomographic imaging.