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.
Category: Clearances
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FDA Clears Nanox.ARC X Imaging System
The system is cleared to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal, and paranasal indications.
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FDA Authorizes Omron’s AI-Powered AFib Detection
Omron Healthcare has received FDA de novo authorization for its IntelliSense blood pressure monitors, which use AI to detect atrial fibrillation with 95% sensitivity and 98% specificity.
Clearances
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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.
FDA OKs SamanTree Medical Histolog Scanner
SamanTree Medical’s Histolog Scanner has received FDA 510(k) clearance for imaging the internal microstructure of tissues, such as cells and vessels.
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FDA OKs AISAP Cardio Ultrasound Platform
AISAP has received U.S. FDA 510(k) clearance for its AI-powered AISAP Cardio platform, which provides comprehensive point-of-care cardiac ultrasound diagnostics and integrates into clinical workflows.
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FDA Clears Procept BioRobotics Hydros Robotic System
Procept BioRobotics has received FDA clearance for its AI-powered Hydros Robotic System, which integrates advanced imaging to improve urology procedures and will be available in U.S. hospitals soon.
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FDA OKs Siemens Healthineers Acuson Origin
Siemens Healthineers has received U.S. FDA clearance for the AI-powered Acuson Origin cardiovascular ultrasound system and the AcuNav Lumos 4D ICE catheter, both designed to improve cardiac diagnostics and patient care.
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Masimo W1 Watch Receives FDA Clearance for Connectivity
The Masimo W1 medical watch received FDA clearance for connectivity, enabling integration with the Masimo SafetyNet telemonitoring solution.
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Diality Receives FDA Clearance for Moda-flx Hemodialysis System
Diality has received U.S. FDA 510(k) clearance for its Moda-flx Hemodialysis System, designed to support various dialysis treatments and improve usability across multiple care settings.
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Varian Receives FDA Clearance for IntelliBlate Ablation System
Varian received FDA 510(k) clearance for its IntelliBlate microwave ablation system, designed for soft tissue ablation.
