FDA | Imaging Technology News

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 ...

January 08, 2024

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 ...

January 08, 2024

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 ...

January 04, 2024

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 ...

December 22, 2023

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 ...

December 20, 2023

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 ...

December 20, 2023

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 ...

December 19, 2023

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 ...

December 13, 2023

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 ...

December 11, 2023

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 ...

December 08, 2023

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 ...

December 08, 2023

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 ...

December 08, 2023

Pixyl has announced FDA 510(k) clearance for Pixyl.Neuro, the next-generation AI software for brain MRI analysis that recently demonstrated enhanced detection rates up to 28%

News | Artificial Intelligence

Pixyl receives FDA clearance for AI-powered brain MRI software Pixyl.Neuro

December 5, 2023 — Pixyl has announced FDA 510(k) clearance for Pixyl.Neuro, the next-generation AI software for brain ...

December 05, 2023

SyntheticMR announced that its next-generation imaging solution with isotropic resolution, SyMRI 3D, is FDA-pending for clinical use in the United States

News | Magnetic Resonance Imaging (MRI)

SyntheticMR Has Submitted Their Next Generation Solution, SyMRI 3D for 510(k) Clearance

November 27, 2023 — SyntheticMR announced that its next-generation imaging solution with isotropic resolution, SyMRI 3D ...

November 27, 2023

Feature | RSNA

RSNA 2023 Day One Highlights: Artificial Intelligence (AI), Radiomics, Regulatory Issues and Health Equity in Imaging

November 27, 2023 — The collective anticipation of the radiology community was palpable from early morning through ...

November 27, 2023

4DMedical, a global technology company and producer of advanced lung function imaging software, has received U.S Food and Drug Administration (FDA) clearance for its CT-based ventilation product (CT LVAS).

News | RSNA

FDA Clearance Granted to 4D Medical for Advanced Lung Function Imaging Software, CT LVAS

November 25, 2023 — 4DMedical, a global technology company and producer of advanced lung function imaging software, has ...

November 24, 2023

The new Siemens Healthineers system offers 20% performance improvement boost throughput

News | PET-CT

Siemens Healthineers Announces FDA Clearance of Biograph Vision.X PET/CT Scanner

November 22, 2023 — Siemens Healthineers has announced the U.S. Food and Drug Administration (FDA) clearance of the ...

November 22, 2023

Lunit INSIGHT DBT receives FDA 510(k) clearance, poised to enter the world's largest DBT marketLun

News | FDA

Lunit Nets FDA Nod for AI-Powered 3D Breast Tomosynthesis Solution, Lunit INSIGHT DBT

November 22, 2023 — Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today ...

November 22, 2023

IONIC Health will add multi-vendor, multi-modality remote scanning capabilities to GE HealthCare's portfolio of effortless operations solutions, including the recently FDA-cleared Digital Expert Access with remote scanning

News | Information Technology

GE HealthCare Announces New Version of Digital Expert Access, the First FDA 510(k)-Cleared Device to Enable Remote Patient Scanning, and Exclusive Distribution Agreement with IONIC Health

November 21, 2023 — GE HealthCare has received U.S. FDA 510(k) Clearance for the new version of Digital Expert Access ...

November 21, 2023

AI-powered NeuroShield automatically quantifies brain volumes using MRI data – the first of its kind with the capability to provide ethnicity-specific reference ranges

News | Artificial Intelligence

InMed AI Receives FDA 510(k) clearance for NeuroShield

November 20, 2023 — InMed.AI (InMed Prognostics Inc.), a pioneer in AI-driven predictive analytics using multi-modal ...

November 20, 2023