FDA

Addition of 21.3-inch High-Definition Mammography Monitor Helps Accelerate LG’s B2B Medical Device Business Growth

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 ...

July 17, 2024

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 ...

July 17, 2024

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 ...

July 15, 2024

Sponsored Content

News | Computed Tomography (CT)

New 128-Slice CT Delivers Big Performance in a Small Footprint

SPONSORED CONTENT — Fujifilm’s latest CT technology brings exceptional image quality to a compact and user- and patient ...

August 06, 2024

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 ...

July 12, 2024

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 ...

July 08, 2024

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 ...

June 27, 2024

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 ...

June 27, 2024

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 ...

June 25, 2024

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 ...

June 19, 2024

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 ...

June 10, 2024

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 ...

May 30, 2024

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 ...

May 22, 2024

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 ...

May 14, 2024

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 ...

May 08, 2024

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 ...

May 03, 2024

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 ...

April 30, 2024

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 ...

April 29, 2024

FDA clearance makes image-guided surgical procedures available to more US patients at lower cost

News | FDA

Philips Zenition 30 Mobile C-arm Receives FDA 510(k) Clearance

April 23, 2024 — Royal Philips , a global leader in health technology, today announced its Philips Zenition 30 mobile C ...

April 23, 2024

LUMISIGHT and Lumicell Direct Visualization System (DVS) offer 84% diagnostic accuracy in detecting residual cancer, in real-time, that may have been otherwise missed during lumpectomy surgery, while sparing some from second surgeries

News | FDA

Lumicell’s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer

April 18, 2024 — Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging ...

April 18, 2024

First completely redesigned mammography platform in over a decade

News | Mammography

Siemens Healthineers Receives FDA 510(k) Clearance for MAMMOMAT B.brilliant Mammography System

April 4, 2024 — Siemens Healthineers announces the Food and Drug Administration 510(k) clearance of the MAMMOMAT B ...

April 04, 2024