FDA

The IGAR system is the first and only robotic guidance and placement system cleared to work inside an MRI bore, one of the most challenging hospital environments
News | Magnetic Resonance Imaging (MRI)
Insight Medbotics Announces World’s First FDA-Cleared, MRI-Compatible Robot

September 14, 2023 — Insight Medbotics, a medical device company combining the accuracy of MRI with the precision of ...

Time September 14, 2023
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First ever radiology triage device to be awarded this status under the FDA Breakthrough Devices Program
News | FDA
Annalise.ai Receives FDA Clearance and Breakthrough Device Designation

September 13, 2023 — Annalise.ai, a leader in AI-powered medical imaging solutions, announced the receipt of 510(k) ...

Time September 13, 2023
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Qure.ai has announced that its AI-enabled Chest X-ray solution for Pneumothorax and Pleural Effusion has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
News | Artificial Intelligence
Qure.ai Announces Receipt of FDA Clearance for Chest X-ray Solution for Pneumothorax and Pleural Effusion, Elevating ICU and ER Care Pathways

September 12, 2023 — Medical imaging Artificial Intelligence (AI) company Qure.ai has announced a pivotal 510(k) ...

Time September 12, 2023
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The AURA 10 is now poised to help enhance surgical outcomes in the United States
News | PET-CT
XEOS Receives Approval by US FDA for the AURA 10 PET-CT Specimen Imager for the Operating Room

September 7, 2023 — The groundbreaking AURA 10 specimen imager by Belgian MedTech pioneer XEOS has been cleared by the ...

Time September 07, 2023
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Kitware leveraged the cutting-edge 3D Slicer medical visualization platform to develop custom medical imaging software and provided support throughout the FDA application process
News | FDA
Kitware Supports Development and Launch of FDA Cleared MR Image Processing Software for Lung Ventilation Imaging

August 18, 2023 — Kitware, a leader in developing innovative medical visualization software, is pleased to announce its ...

Time August 18, 2023
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