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Claria Medical Secures FDA De Novo Clearance for Hysterectomy Tissue Extraction System
The Claria System is designed to improve safety and efficiency during minimally invasive hysterectomy procedures by providing a controlled tissue extraction approach.

nuaxia
Jul 143 min read


FDA Clears iHealthScreen’s AI Diabetic Retinopathy Screening Software
iPredict-DR uses artificial intelligence to analyse retinal images and support earlier detection of diabetic eye disease.

nuaxia
Jul 133 min read


FDA Clears Zeta Surgical’s AI-Powered Robotic TMS Navigation System for Treatment-Resistant Depression
Zeta Surgical’s robotic navigation platform uses AI and computer vision to improve precision and repeatability during transcranial magnetic stimulation procedures.

nuaxia
Jul 133 min read


FDA Clears AI-Powered Diabetic Retinopathy Screening Software from iHealthScreen
The AI-powered software analyses retinal images captured by the widely used iCare DRSplus camera, supporting earlier detection of diabetic retinopathy in primary care and community healthcare settings.

nuaxia
Jul 103 min read


Distalmotion Expands FDA Clearance for DEXTER Robotic System in Gynaecology
Swiss medical device company Distalmotion has secured additional US Food and Drug Administration (FDA) 510(k) clearance for its DEXTER robotic surgery system, further expanding its role in minimally invasive gynaecological procedures.

nuaxia
Jun 223 min read


KARL STORZ Secures FDA Clearance for RUBINA Lens, Expanding Fluorescence Imaging into Open Surgery
KARL STORZ has received US Food and Drug Administration (FDA) clearance for its RUBINA Lens exoscope, enabling the company to bring its near-infrared (NIR) fluorescence imaging technology into open surgical procedures.

nuaxia
Jun 133 min read


Subtle Medical Expands AI Imaging Platform with FDA Clearance for CT Enhancement Software
Subtle Medical has received FDA clearance for SubtleHD(CT), an AI-powered software platform designed to improve computed tomography (CT) image quality by reducing noise and enhancing low-contrast detectability.

nuaxia
Jun 123 min read


Philips Takes Ultrasound Into the AI Workflow Era with FDA Clearance for Elevate Plus
Philips has received FDA 510(k) clearance for Elevate Plus, an AI-enabled upgrade to its EPIQ Elite and Affiniti ultrasound systems, alongside CE mark approval in Europe.

nuaxia
Jun 73 min read
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