Philips Receives FDA Clearance for Rembra CT Platform
Clearances for Rembra CT, Rembra RT, and Areta RT aim to enable high-throughput imaging at scale and elevate precision across the cancer care pathway.
Category: Clearances
Clearances
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Clearances
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FDA Clears Medtronic Surgical System for Cranial and ENT Procedures
The platform combines planning, navigation, and robotics, with AI-enabled features for imaging and workflow support.
Clearances
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FDA Clears Platform for Noninvasive Cardiac Conduction System Visualization
The CTA-based system creates a patient-specific 3D map of the cardiac conduction system to support planning and guidance during procedures such as TAVR and conduction system pacing.
Clearances
Latest
Philips Receives FDA Clearance for Rembra CT Platform
Clearances for Rembra CT, Rembra RT, and Areta RT aim to enable high-throughput imaging at scale and elevate precision across the cancer care pathway.
FDA Clears Elekta’s AI-Powered CT-Linear Accelerator
Elekta’s Evo system combines CT-guided radiation therapy with AI-enhanced imaging designed to support visualization of tumors and nearby organs at risk during treatment.
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FDA Clears Silicon Photonics System for Lung Biopsy Procedures
The system integrates depth imaging technology directly into biopsy tools to improve tissue sampling accuracy during bronchoscopy.
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FDA Clears Multi-Modality Breast Biopsy and Tissue Removal System
The newly cleared system is designed to support breast biopsy procedures across multiple imaging modalities using a single platform.
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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 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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FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound
The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.
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Clearances
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AI-Driven Coronary Physiology Software Gains FDA Clearance
The software, powered by artificial intelligence and deep learning, assesses angiography-derived coronary physiology in patients with ischemic coronary artery disease.
