FDA | Imaging Technology News

AI Tool Receives FDA Approval for Cervical Spine Fracture Detection

Sept. 19, 2024 – Medical imaging AI company Avicenna.AI recently announced it had received 510(k) clearance from the U.S ...

September 19, 2024

News | PET Imaging

PET Tracer Receives FDA Fast Track Designation for Alzheimer's Diagnosis

Aug. 28, 2024 – AC Immune SA recently announced that its partner Life Molecular Imaging (LMI) has received Fast Track ...

August 29, 2024

News | Cardiac Imaging

Nanox Receives FDA Approval for Latest Version of AI Cardiac Imaging Product

Aug. 21, 2024 — NANO-X IMAGING LTD recently announced that its deep-learning medical imaging analytics subsidiary, Nanox ...

August 23, 2024

News | Ultrasound Imaging

AISAP’s CARDIO AI-powered Diagnostic Assessment Software Receives FDA Clearance

Aug. 22, 2024 – AISAP has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for ...

August 22, 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

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) ...

July 24, 2024

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 ...

July 22, 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 18, 2024 — NeuroLogica Corp, a subsidiary of Samsung Electronics Co. Ltd., announced its latest configuration of ...

July 18, 2024

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 ...

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

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

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