FDA

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 ...

Time December 05, 2023
arrow
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 ...

Time November 27, 2023
arrow
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 ...

Time November 27, 2023
arrow
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 ...

Time November 24, 2023
arrow
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 ...

Time November 22, 2023
arrow
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 ...

Time November 22, 2023
arrow
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 ...

Time November 21, 2023
arrow
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 ...

Time November 20, 2023
arrow
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 ...

Time November 16, 2023
arrow
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 ...

Time November 09, 2023
arrow
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 ...

Time November 07, 2023
arrow
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 ...

Time October 30, 2023
arrow
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 ...

Time October 18, 2023
arrow
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 ...

Time October 16, 2023
arrow
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 ...

Time October 12, 2023
arrow
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 ...

Time September 28, 2023
arrow
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 ...

Time September 14, 2023
arrow
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) ...

Time September 13, 2023
arrow
Qure.ai has announced that its AI-enabled Chest X-ray solution for Pneumothorax and Pleural Effusion has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
News | Artificial Intelligence
Qure.ai Announces Receipt of FDA Clearance for Chest X-ray Solution for Pneumothorax and Pleural Effusion, Elevating ICU and ER Care Pathways

September 12, 2023 — Medical imaging Artificial Intelligence (AI) company Qure.ai has announced a pivotal 510(k) ...

Time September 12, 2023
arrow
The AURA 10 is now poised to help enhance surgical outcomes in the United States
News | PET-CT
XEOS Receives Approval by US FDA for the AURA 10 PET-CT Specimen Imager for the Operating Room

September 7, 2023 — The groundbreaking AURA 10 specimen imager by Belgian MedTech pioneer XEOS has been cleared by the ...

Time September 07, 2023
arrow
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now