FDA

Telix Pharmaceuticals Limited announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TLX007-CDx
News | Radiopharmaceuticals and Tracers
FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent

July 24, 2024 — Telix Pharmaceuticals Limited announced that the United States (U.S.) Food and Drug Administration (FDA) ...

Time July 24, 2024
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Healthcare artificial intelligence (AI) systems provider, Qure.ai, has announced its receipt of a Class III medical device license from Health Canada for all its medical imaging AI solutions according to a statement released by the company, led by co-founder and CEO, Prashant Warier.
News | Artificial Intelligence
Qure.ai Receives Class III Medical Device License Approval from Health Canada 

July 22, 2024 — Healthcare artificial intelligence (AI) systems provider, Qure.ai, has announced its receipt of a Class ...

Time July 22, 2024
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NeuroLogica Corp, a subsidiary of Samsung Electronics Co. Ltd., announced its latest configuration of the mobile computed tomography (CT) OmniTom Elite with Photon Counting Detector (PCD) technology has received U.S. Food and Drug Administration (FDA) 510(k) clearance
News | Computed Tomography (CT)
NeuroLogica Corp Receives FDA 510(k) Clearance for Enhanced OmniTom Elite with Ultra-High Resolution PCD Technology

July 18, 2024 — NeuroLogica Corp, a subsidiary of Samsung Electronics Co. Ltd., announced its latest configuration of ...

Time July 18, 2024
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Addition of 21.3-inch High-Definition Mammography Monitor Helps Accelerate LG’s B2B Medical Device Business Growth
News | Flat Panel Displays
LG Launches 5MP Diagnostic Monitor for Breast Imaging

July 17, 2024 — LG Electronics (LG) is accelerating its B2B medical device business, expanding its lineup of diagnostic ...

Time July 17, 2024
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The total number of Hyperfine AI-powered marketing authorizations places the company in a leading position on recently published FDA list
News | Artificial Intelligence
Hyperfine Announces FDA Clearance of Software Update That Enables Faster Acquisition of Best-in-Class Ultra-Low-Field Brain Images

July 17, 2024 — Hyperfine, a groundbreaking medical device company that has redefined brain imaging with the world’s ...

Time July 17, 2024
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NeuroLogica Corp, a subsidiary of Samsung Electronics Co. Ltd., announced its latest configuration of the mobile computed tomography (CT) OmniTom Elite with Photon Counting Detector (PCD) technology has received U.S. Food and Drug Administration (FDA) 510(k) clearance
News | Computed Tomography (CT)
NeuroLogica Corp Receives FDA 510(k) Clearance for Enhanced OmniTom Elite with Ultra-High Resolution PCD Technology

July 15, 2024 — NeuroLogica Corp, a subsidiary of Samsung Electronics Co. Ltd., announced its latest configuration of ...

Time July 15, 2024
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Digital workflows help to improve diagnostic accuracy and efficiency by integrating pathology into broader precision diagnostic systems and IT infrastructure
News | Digital Pathology
Philips Strengthens its Leadership in Digital Pathology as its Philips IntelliSite Pathology Solution Receives 510(k) Clearance

July 12, 2024 — Diagnosing cancer and providing the personalized therapy it often requires, is a collaborative effort ...

Time July 12, 2024
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Last Read
Feature | Radiology Business
Last Read

ITN conducts a bi-monthly survey to its readers on a variety of topics, which is used to create the Last Read, a unique ...

Time July 08, 2024
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Clarius Mobile Health has announced that is has obtained U.S. Food and Drug Administration (FDA) clearance for the Clarius OB AI fetal biometric measurement tool.
News | Artificial Intelligence
FDA Clears Clarius OB AI for Handheld Ultrasound for Prenatal Monitoring

June 27, 2024 — Clarius Mobile Health, which provides high-definition handheld ultrasound systems, has obtained U.S ...

Time June 27, 2024
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Thirona, a provider of advanced lung image analysis with artificial intelligence, led by scientist now CEO Eva van Rikxoort, has recently announced multiple partnerships.
News | Artificial Intelligence
Thirona Announces Partnerships to Enhance AI-based Lung Image Analysis

June 27, 2024 — Thirona, a Netherlands-based global company providing high-precision advanced lung image analysis with ...

Time June 27, 2024
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System is aimed at the hospital and outpatient market and incorporates features to improve image quality and workflow, and reduce patient dose
News | Computed Tomography (CT)
Fujifilm Launches 128-Slice Computed Tomography System, FCT iStream, with Vision Modeling Iterative Reconstruction

June 25, 2024 — Fujifilm Healthcare Americas Corporation, a leading provider of diagnostic and enterprise imaging ...

Time June 25, 2024
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Automated workflows contribute to greater flexibility and independence for clinicians, providing more time to focus on achieving the best possible outcomes for patients
News | Mobile C-Arms
Philips Zenition 90 Motorized receives FDA 510(k) clearance, helping clinicians deliver high quality care with a high-powered and fast motorized mobile C-arm

June 19, 2024 —Royal Philips, a global leader in health technology, today announced the launch of Philips Image Guided ...

Time June 19, 2024
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Addresses all clinical needs, including oncology, theranostics, cardiology, and neurology
News | FDA
Siemens Healthineers Receives FDA Clearance for High-Performance Biograph Trinion PET/CT Scanner

June 10, 2024 — Siemens Healthineers announces the Food and Drug Administration clearance of the Biograph Trinion, a ...

Time June 10, 2024
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VUZE Medical has announced its receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its second-generation VUZE System.
News | FDA
Vuze Medical Announces FDA 510(k) Clearance for 2nd Generation Software-based 3-D Guidance System for Spine Surgery

May 30, 2024 — Vuze Medical, which develops medical technology to transform intra-operative guidance in spinal ...

Time May 30, 2024
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The U.S. Food and Drug Administration (FDA) has issued a recall of the Hologic, Inc. BioZorb marker due to complications with implanted devices.
News | FDA
Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices

May 22, 2024 — The U.S. Food and Drug Administration (FDA) has issued a recall of the Hologic Inc. BioZorb marker due to ...

Time May 22, 2024
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This 510(k) clearance allows HALO AP Dx to be utilized in conjunction with the Hamamatsu NanoZoomer S360MD Slide scanner for in-vitro diagnostic use and sets the stage for use with additional FDA-cleared slide scanners in the future
News | FDA
Indica Labs Receives First FDA Clearance for HALO AP Dx Digital Pathology Platform

May 14, 2024 — Indica Labs, the leading provider of digital pathology solutions, announced today that it received FDA ...

Time May 14, 2024
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Swedish biotech company Ascelia Pharma has announced its liver imaging drug candidate, Orviglance, significantly improved visualization of focal liver lesions, having successfully met the primary endpoint in the pivotal Phase 3 study, SPARKLE. CEO Magnus Corftizen shown here, offered an update on the first-in-class contrast agent for use in liver MRI in patients with severely impaired kidney function which has been granted FDA Orphan Drug Designation.
News | Contrast Media
Ascelia Pharma Meets Primary Endpoint in Phase 3 Study of Orviglance Liver Imaging Contrast Agent Drug Candidate

May 8, 2024 — Swedish biotech company Ascelia Pharma AB has announced that its liver imaging drug candidate, Orviglance ...

Time May 08, 2024
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A look at ITN's top-viewed content for April 2024
Feature | Radiology Business | By Melinda Taschetta-Millane
Top 10: What Viewers Were Reading in April

One on One interviews with radiology trailblazers and historic FDA clearances made the top-read list for April. Take a ...

Time May 03, 2024
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Sectra and Leica Biosystems First in the World to Gain FDA Clearance to Utilize DICOM Images for Pathology Diagnostics
News | FDA
Sectra and Leica Biosystems First in the World to Gain FDA Clearance to Utilize DICOM Images for Pathology Diagnostics

April 30, 2024 — International medical imaging IT and Cybersecurity company Sectra’s digital pathology solution together ...

Time April 30, 2024
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Elekta Instrument AB recalls disposable biopsy needle kit for Leksell Stereotactic System for possibly containing microscopic stainless steel febris on the inside of the biopsy needle
News | FDA
FDA Announces Elekta Recall of Biopsy Needle Kit for Leksell Stereotactic System

April 29, 2024 — The U.S. Food and Drug Administration (FDA) announced Elekta Instrument AB is recalling Disposable ...

Time April 29, 2024
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