FDA

Four FDA clearances and 61 EU MDR CE tags achieved for AI in 18 months
News | Artificial Intelligence
Qure.ai Adds New FDA Breakthrough Device Status to Growing List of Regulatory Milestones

February 6, 2024 — Medical imaging AI innovator, Qure.ai, has received breakthrough device designation from the Food and ...

Time February 06, 2024
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Augmento X-Ray is designed to significantly reduce radiologist workload and improve the quality of chest X-ray reporting
News | Artificial Intelligence
DeepTek.ai Unveiled the World's First Commercially Available US FDA Cleared CADe Chest X-Ray AI Solution Covering the Entire Chest Region at RSNA23

February 2, 2024 — DeepTek.ai, a leading provider of artificial intelligence (AI) solutions for medical imaging ...

Time February 02, 2024
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IceCure Medical Ltd. has announced that the Food and Drug Administration (FDA) has granted its appeal and reopened its De Novo Classification Request for Marketing Authorization of its ProSense cryoablation technology for early-stage breast cancer.
News | FDA
FDA Grants IceCure Medical's Appeal: Reopens De Novo Classification Request for Marketing Authorization of ProSense for Early-Stage Breast Cancer

January 30, 2024 — IceCure Medical Ltd. has announced the U.S. Food and Drug Administration (FDA) has responded ...

Time January 30, 2024
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InkSpace Imaging gets FDA clearance for its Siemens 3T MRI compatible Small body array
News | Magnetic Resonance Imaging (MRI)
InkSpace Imaging receives FDA Clearance for a 24-channel Small Body Array Compatible with Siemens Healthineers 3T Systems

January 26, 2024 — InkSpace Imaging, a leader in innovative diagnostic medical device technology, is proud to announce ...

Time January 26, 2024
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RSNA23 kicked off on Nov. 26, welcoming attendees and exhibitors back to another year of showcasing new trends and technology in the field of radiology.
Gallery | RSNA | By Melinda Taschetta-Millane and Christine Book
Photo Gallery of Radiology Technology, Highlights from RSNA 2023

This gallery includes photos of the wide range of medical imaging technologies, scientific sessions, educational courses ...

Time January 26, 2024
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syngo Virtual Cockpit Enables remote scanning and support for up to three scanners simultaneously
News | FDA
Siemens Healthineers Announces FDA Clearance of syngo Virtual Cockpit Remote Scanning Technology

January 23, 2024 — Siemens Healthineers announces the Food and Drug Administration (FDA) clearance of syngo Virtual ...

Time January 23, 2024
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LungQ 3.0.0 builds on 10 years of clinical trials and 200+ publications to deliver advanced segmentation of pulmonary segments and subsegments
News | Artificial Intelligence
Thirona receives FDA 510(k) Clearance for LungQ v3.0.0 Software to Power AI Analysis of Chest CT Images

January 22, 2024 — Thirona, a global company specializing in advanced analysis of thoracic CT images with artificial ...

Time January 22, 2024
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With this new approval, people with a Proclaim DRG neurostimulation system can soon receive full-body MRI scans
News | Magnetic Resonance Imaging (MRI)
Abbott Secures FDA Approval for MRI Labeling Expansion for the Proclaim DRG Neurostimulation System

January 18, 2024 — Abbott announced that the U.S. Food and Drug Administration (FDA) has approved expanded MRI labeling ...

Time January 18, 2024
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Butterfly iQ3 will feature a brand-new ergonomic design, to be revealed soon. (Graphic: Business Wire)
News | Point-of-Care Ultrasound (POCUS)
Butterfly Network Announces FDA Clearance of its Next-generation Handheld Ultrasound System, Butterfly iQ3

January 8, 2024 — Butterfly Network, Inc., a digital health company transforming care through the power of portable ...

Time January 08, 2024
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This reinforces Qure.ai's position as a pioneer in the field of AI-powered advancements for plain film radiography and medical imaging
News | Artificial Intelligence
Qure.ai's AI-Driven Chest X-ray Solution Receives FDA Clearance for Enhanced Lung Nodule Detection

January 8, 2024 — Qure.ai, a leading global innovator in medical imaging solutions, has announced its 13th FDA clearance ...

Time January 08, 2024
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New features address major obstacles for scientific community, can advance research
News | Magnetic Resonance Imaging (MRI)
Siemens Healthineers Announces FDA Clearance of Magnetom Cima.X 3 Tesla Magnetic Resonance Scanner

January 4, 2024 — Siemens Healthineers announced the Food and Drug Administration clearance of the Magnetom Cima.X 3 ...

Time January 04, 2024
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Product significantly improves patient outcomes by enabling earlier diagnosis
News | Artificial Intelligence
Quibim’s AI-based Early-stage Neurological Disease Quantification Software for Quantification of Early Brain Atrophy and Lesions Authorized for Use in US, EU and UK

December 22, 2023 — Quibim, a company pioneering imaging biomarkers for Precision Medicine that has created AI-based ...

Time December 22, 2023
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Terran Biosciences, Inc., a biotech platform company developing therapeutics and technologies for patients with neuropsychiatric illnesses, has received FDA clearance to market NM-101
News | Magnetic Resonance Imaging (MRI)
Terran Biosciences Receives FDA Clearance for NM-101, the Industry’s First Software for the Analysis of Neuromelanin-sensitive MRI

December 20, 2023 — Terran Biosciences, Inc., a biotech platform company developing therapeutics and technologies for ...

Time December 20, 2023
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The FDA has identified this as a Class I recall, the most serious type of recall
News | Magnetic Resonance Imaging (MRI)
Philips North America LLC Recalls Panorama 1.0T HFO Due to a Risk of Explosion

December 20, 2023 — According to the U.S. Food and Drug Administration (FDA), Philips North America LLC is recalling ...

Time December 20, 2023
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Embedded AI and user assistance features deliver workflow efficiencies
News | Computed Tomography (CT)
Siemens Healthineers Announces FDA Clearance of Somatom Pro.Pulse Dual-Source CT Scanner

December 19, 2023 — Siemens Healthineers announced the Food and Drug Administration (FDA) clearance of the Somatom Pro ...

Time December 19, 2023
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News | Radiology Business
Merger Announced by 4D Medical and Imbio Creates Cardiothoracic Image Analysis Portfolio

December 13, 2023 — The global medical technology company 4DMedical has announced it has entered a binding agreement to ...

Time December 13, 2023
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Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway (gadopiclenol) in the European Union
News | Contrast Media
The European Commission Grants Marketing Authorization to Bracco Imaging for Vueway (gadopiclenol) Contrast Agent in the European Union

December 11, 2023 — Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions ...

Time December 11, 2023
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As part of the latest Critical Care Suite 2.1 offering, new on-device AI helps detect and localize pneumothorax (PTX) – providing immediate notification and overlay for the presence or absence of PTX
News | Artificial Intelligence
GE HealthCare Expands On-Device Triage Capabilities of Critical Care Suite with FDA Clearance of Algorithm for Pneumothorax Detection, Notification, Triage and Diagnosis

December 8, 2023 — GE HealthCare announced an industry-first US FDA 510K clearance of Critical Care Suite 2.1 featuring ...

Time December 08, 2023
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With the FDA clearance, the company is now able to commercially provide the AI solution to medical professionals and healthcare institutions in the U.S.
News | Artificial Intelligence
Bering Limited Secures FDA Clearance for AI-Based Chest X-Ray Triage Solution

December 8, 2023 — Bering Limited, a London-based medical AI company, today announced it received U.S. Food and Drug ...

Time December 08, 2023
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Siemens Healthineers Introduces Acuson Maple Workhorse Ultrasound System
News | Ultrasound Imaging
Siemens Healthineers Introduces Acuson Maple Workhorse Ultrasound System

December 8, 2023 — Siemens Healthineers introduced the Acuson Maple¹, a powerful, versatile, and affordable ultrasound ...

Time December 08, 2023
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