FDA

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.

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

The V6 ultrasound system is specifically designed to offer clinicians a versatile solution that efficiently supports the daily clinical demands in Women’s Health and Urology.

News | Ultrasound Imaging

Samsung Launches New Ultrasound System ‘V6’ Where Performance Meets Efficiency

November 16, 2023 — Boston Imaging, the United States headquarters of Samsung’s digital radiography and ultrasound ...

November 16, 2023

Further enhancing comprehensive trauma care solution

News | Artificial Intelligence

RapidAI Receives FDA Clearance of AI Module for Detection of Hemispheric Subdural Hematomas

November 9, 2023 — RapidAI, a global leader in developing artificial intelligence (AI) and technology workflow solutions ...

November 09, 2023

Whiterabbit’s WRDensity is the first FDA-cleared AI-driven breast density product on ACR’s platform

News | Breast Density

Whiterabbit Collaborates with the American College of Radiology to Enable Democratized Access to Artificial Intelligence

November 7, 2023 — Whiterabbit.ai, an AI-technology company dedicated to making late-stage diseases a rarity, announced ...

November 07, 2023

Paige Lymph Node detects the presence of breast cancer metastases with near-perfect sensitivity with the power of AI

News | Artificial Intelligence

U.S. FDA Grants Paige Breakthrough Device Designation for Cancer Detection in Breast Lymph Nodes

October 30, 2023 — Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications that ...

October 30, 2023

This AI model accelerates decision-making by detecting and locating suspicious lesions in chest X-rays

News | Artificial Intelligence

DeepTek.ai secures US FDA clearance for its groundbreaking Chest X-ray AI solution

October 18, 2023 — DeepTek.ai, a leading medical imaging AI company in India has announced that it has received ...

October 18, 2023

Advanced ultrasound technology with artificial intelligence applications to support clinicians of all skill levels in efficiently diagnosing lung pathology and traumatic injury

News | Teleradiology

Rology Earns the First FDA Clearance for a 2-sided and On-demand Teleradiology Platform

October 16, 2023 — Rology, a leading AI-assisted teleradiology platform in the Middle East and Africa, announced that it ...

October 16, 2023

Advanced artificial intelligence (AI) algorithms are now integrated across all Swoop® ultra-low-field brain imaging system sequences

News | Magnetic Resonance Imaging (MRI)

Hyperfine, Inc. Receives FDA Clearance for Updated AI-powered Software with Improved Image Quality for All Swoop System Sequences

October 12, 2023 — Hyperfine, Inc., a groundbreaking medical device company that has redefined brain imaging with the ...

October 12, 2023

Mobile 1.5T system brings high-quality diagnostic imaging to offsite locations

News | Magnetic Resonance Imaging (MRI)

Siemens Healthineers Announces FDA Clearance of Magnetom Viato.Mobile Magnetic Resonance Scanner

September 28, 2023 — Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Magnetom ...

September 28, 2023

The IGAR system is the first and only robotic guidance and placement system cleared to work inside an MRI bore, one of the most challenging hospital environments

News | Magnetic Resonance Imaging (MRI)

Insight Medbotics Announces World’s First FDA-Cleared, MRI-Compatible Robot

September 14, 2023 — Insight Medbotics, a medical device company combining the accuracy of MRI with the precision of ...

September 14, 2023

First ever radiology triage device to be awarded this status under the FDA Breakthrough Devices Program

News | FDA

Annalise.ai Receives FDA Clearance and Breakthrough Device Designation

September 13, 2023 — Annalise.ai, a leader in AI-powered medical imaging solutions, announced the receipt of 510(k) ...

September 13, 2023