FDA

Siemens Healthineers Receives FDA 510(k) Clearance for MAMMOMAT B.brilliant Mammography System
April 4, 2024 — Siemens Healthineers announces the …
Top 10: Must-reads from the Month of March
Here is a snapshot of the Top 10 most-read content from ITN's viewers during the month of March:
Siemens Healthineers Announces FDA Clearance of MAGNETOM Terra.X 7-Tesla Magnetic Resonance Scanner
March 27, 2024 — Siemens Healthineers announces the
SyntheticMR Receives FDA 510(k) Clearance for its Next Generation Solution SyMRI 3D
March 27, 2024 — SyntheticMR announced that its next-generation imaging solution, SyMRI 3D, has received…
Siemens Healthineers Announces FDA Clearance of CIARTIC Move Self-Driving Mobile C-arm
March 21, 2024 — Siemens Healthineers has announced the Food and Drug Administration (

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

Here is a look at the most-read content during the month of March on itnonline.com

Feature | Radiology Business | By Melinda Taschetta-Millane

Top 10: Must-reads from the Month of March

Here is a snapshot of the Top 10 most-read content from ITN's viewers during the month of March: 1. Philips Teams with ...

April 04, 2024

Enabling off-site experts to remotely provide real-time guidance to the licensed technologist operating the scanner

News | Radiology Imaging

GE HealthCare Announces the FDA Clearance of nCommand Lite by IONIC Health

April 3, 2024 — GE HealthCare announced the U.S. FDA 510(k) Clearance of IONIC Health’s nCommand Lite technology. The ...

April 03, 2024

Delivers higher image resolution and visualization of smaller structures

News | Magnetic Resonance Imaging (MRI)

Siemens Healthineers Announces FDA Clearance of MAGNETOM Terra.X 7-Tesla Magnetic Resonance Scanner

March 27, 2024 — Siemens Healthineers announces the Food and Drug Administration (FDA) clearance of the MAGNETOM Terra.X ...

March 27, 2024

SyntheticMR announced today that their next-generation imaging solution with isotropic resolution, SyMRI 3D, has received FDA 510(k) clearance for clinical use in the United States

News | FDA

SyntheticMR Receives FDA 510(k) Clearance for its Next Generation Solution SyMRI 3D

March 27, 2024 — SyntheticMR announced that its next-generation imaging solution, SyMRI 3D, has received FDA 510(k) ...

March 27, 2024

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the CIARTIC Move, a mobile C-arm with self-driving capabilities.

News | FDA

Siemens Healthineers Announces FDA Clearance of CIARTIC Move Self-Driving Mobile C-arm

March 21, 2024 — Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the CIARTIC Move ...

March 21, 2024

For the first time in a commercial setting, physicians are able to see the extent of disease and provide more personalized and precise treatments for prostate cancer patients using AI

News | Artificial Intelligence

Avenda Health Announces First Commercial Use of Unfold AI on Prostate Cancer Patients in the US

March 21, 2024 — Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care ...

March 21, 2024

AI, including machine learning (ML), spans transformative technologies with the potential to revolutionize healthcare

News | Artificial Intelligence

Artificial Intelligence Paper Outlines FDA’s Approach to Protect Public Health and Promote Ethical Innovation

March 15, 2024 — Today, the U.S. Food and Drug Administration (FDA) released its “Artificial Intelligence and Medical ...

March 15, 2024

Medical imaging AI company DeepTek.ai will showcase its groundbreaking US FDA-cleared chest X-ray reporting AI solution, Augmento X-Ray, during HIMSS 2024 being held March 11-15 in Orlando, FL.

News | HIMSS

Deetptek.ai Showcases Chest X-ray AI solution, Augmento X-ray, at HIMSS 2024

March 8, 2024 — DeepTek.ai, a leading medical imaging AI company, will showcase its groundbreaking US FDA-cleared chest ...

March 08, 2024

News | Breast Imaging

Lumicell Announces FDA Advisory Committee’s Positive Recommendation on the Benefit-Risk Profile of LUMISIGHT in the Detection of Cancerous Tissue During Breast Conserving Surgery

March 8, 2024 — Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies ...

March 08, 2024

Lantheus announced that the U.S. Food and Drug Adminstration (FDA) has approved DEFINITY (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms, including those who have undergone heart transplant, or have Kawasaki disease or a congenital cardiovascular anomaly.

News | FDA

Lantheus Announces the FDA Approval of DEFINITY as Ultrasound Enhancing Agent for Use in Certain Pediatric Cardiovascular Patients

March 6, 2024 — Lantheus Holdings, Inc. (Lantheus), a radiopharmaceutical company, has announced that the U.S. Food and ...

March 06, 2024

HyperSight is designed to enhance accuracy in delivering radiotherapy treatments, with the goal of effective protection of healthy tissues

News | FDA

Varian Receives FDA 510(k) Clearance for TrueBeam and Edge Radiotherapy Systems Featuring HyperSight Imaging Solution

March 1, 2024 — Varian, a Siemens Healthineers company, announced that it has received 510(k) clearance from the U.S ...

March 01, 2024

The FDA recalls the Philips BrightView XCT

News | SPECT Imaging

Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling

February 15, 2024 — According to a release issued by the U.S. Food and Drug Administration (FDA), Philips is recalling ...

February 15, 2024

New guidance system marks significant advancement in breast cancer care, targeting tumor location in multiple dimensions for precise excision and successful surgeries

News | FDA

Merit Medical Receives FDA 510(k) Clearance for SCOUT MD Surgical Guidance System

February 15, 2024 — Merit Medical Systems, Inc., a global leader of healthcare technology, has received US Food and Drug ...

February 15, 2024

Butterfly iQ3 is built on the next-generation P4.3 Ultrasound-on-Chip technology with the world’s fastest digital data transfer, enhancing frame rates, frequency and new 3D imaging capabilities – all on a smaller, lighter and more ergonomically designed probe

News | Point-of-Care Ultrasound (POCUS)

Butterfly Network Launches Next-Generation Butterfly iQ3 in the United States

February 13, 2024 — Butterfly Network, Inc., a digital health company transforming care through the power of portable ...

February 13, 2024

Nanox’s HealthFLD is pioneering the use of a fully automated AI software for liver attenuation analysis from CT scans that has received FDA 510(k) clearance for use in general population

News | Artificial Intelligence

Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver

February 13, 2024 — Nanox, an innovative medical imaging technology company, today announced that its deep-learning ...

February 13, 2024

Proscia, a software company accelerating the transformation to digital pathology, has announced its receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Concentriq AP-Dx for the purpose of primary diagnosis.

News | FDA

Proscia Receives FDA Clearance for Digital Pathology Software Solution

February 12, 2024 — Proscia, a leading provider of digital and computational pathology solutions, has received 510(k) ...

February 12, 2024

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 ...

February 06, 2024