FDA

The V6 ultrasound system is specifically designed to offer clinicians a versatile solution that efficiently supports the daily clinical demands in Women’s Health and Urology.
News | Ultrasound Imaging
Samsung Launches New Ultrasound System ‘V6’ Where Performance Meets Efficiency

November 16, 2023 — Boston Imaging, the United States headquarters of Samsung’s digital radiography and ultrasound ...

Time November 16, 2023
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Further enhancing comprehensive trauma care solution
News | Artificial Intelligence
RapidAI Receives FDA Clearance of AI Module for Detection of Hemispheric Subdural Hematomas

November 9, 2023 — RapidAI, a global leader in developing artificial intelligence (AI) and technology workflow solutions ...

Time November 09, 2023
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Whiterabbit’s WRDensity is the first FDA-cleared AI-driven breast density product on ACR’s platform
News | Breast Density
Whiterabbit Collaborates with the American College of Radiology to Enable Democratized Access to Artificial Intelligence

November 7, 2023 — Whiterabbit.ai, an AI-technology company dedicated to making late-stage diseases a rarity, announced ...

Time November 07, 2023
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Paige Lymph Node detects the presence of breast cancer metastases with near-perfect sensitivity with the power of AI
News | Artificial Intelligence
U.S. FDA Grants Paige Breakthrough Device Designation for Cancer Detection in Breast Lymph Nodes

October 30, 2023 — Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications that ...

Time October 30, 2023
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This AI model accelerates decision-making by detecting and locating suspicious lesions in chest X-rays
News | Artificial Intelligence
DeepTek.ai secures US FDA clearance for its groundbreaking Chest X-ray AI solution

October 18, 2023 — DeepTek.ai, a leading medical imaging AI company in India has announced that it has received ...

Time October 18, 2023
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Advanced ultrasound technology with artificial intelligence applications to support clinicians of all skill levels in efficiently diagnosing lung pathology and traumatic injury
News | Teleradiology
Rology Earns the First FDA Clearance for a 2-sided and On-demand Teleradiology Platform

October 16, 2023 — Rology, a leading AI-assisted teleradiology platform in the Middle East and Africa, announced that it ...

Time October 16, 2023
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Advanced artificial intelligence (AI) algorithms are now integrated across all Swoop® ultra-low-field brain imaging system sequences
News | Magnetic Resonance Imaging (MRI)
Hyperfine, Inc. Receives FDA Clearance for Updated AI-powered Software with Improved Image Quality for All Swoop System Sequences

October 12, 2023 — Hyperfine, Inc., a groundbreaking medical device company that has redefined brain imaging with the ...

Time October 12, 2023
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Mobile 1.5T system brings high-quality diagnostic imaging to offsite locations
News | Magnetic Resonance Imaging (MRI)
Siemens Healthineers Announces FDA Clearance of Magnetom Viato.Mobile Magnetic Resonance Scanner

September 28, 2023 — Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Magnetom ...

Time September 28, 2023
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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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