RADLogics Secures FDA Clearance for AI-Powered Chest X-Ray App for Triage & Prioritization

RADLogics Secures FDA Clearance for AI-Powered Chest X-Ray App for Triage & Prioritization
RADLogics Secures FDA Clearance for AI-Powered Chest X-Ray App for Triage & Prioritization

What You Should Know:

– RADLogics today announced that it has secured
510(k) clearance from the FDA for the company’s novel AI-Powered chest X-ray pneumothorax application,
which identifies and prioritizes chest X-ray scans that appear
to contain a pneumothorax, a collapsed lung, for urgent radiologist review.

– RADLogics’ FDA cleared CT and X-ray solutions
– including this application – are available to hospitals and
healthcare systems throughout the U.S. for patient triage and
management. All of these applications are available immediately through
the Nuance AI Marketplace for Diagnostic Imaging.


RADLogics, a healthcare company developing AI-Powered solutions that support image analysis to improve radiologists’ productivity while enhancing patient outcomes, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its novel AI-Powered chest X-ray pneumothorax application. The clearance paves the way for healthcare providers, hospital networks, and clinicians to have access to artificial intelligence (AI) software that is trained via pattern recognition to process chest X-rays and immediately flag scans with a suspected pneumothorax, a collapsed lung, for urgent radiologist review.

How RADLogics AI-Powered Solution Works

Operating in parallel with existing workflow, RADLogics’
chest X-ray solution uses an artificial intelligence algorithm to analyze
images for features suggestive of pneumothorax. It then makes case-level output
available to a PACS workstation for worklist prioritization or triage. The
AI-Powered solution integrates into a comprehensive, seamless, and secure
workflow to augment acute care teams with deep clinical insight and actionable
data in minutes. The application was validated and trained by a multi-center
study for detecting pneumothorax in hundreds of chest X-rays.

In accordance with FDA guidance for imaging systems and
software to address the COVID-19 public health emergency, RADLogics has made
its FDA cleared X-ray and CT solutions available to hospitals and healthcare
systems throughout the U.S. for patient triage and management. Designed for
easy integration and installation both on-premise and via the cloud –
RADLogics’ algorithms are supported by the company’s patented workflow software
platform that enables rapid deployment at multiple hospitals, and seamless
integration with existing workflows.

“We are very pleased to receive FDA 510(k) clearance for our AI-Powered chest X-ray pneumothorax application, which adds to our array of AI-Powered solutions for CT and X-ray that are designed to improve efficiency and reduce burnout for radiologists that are under greater pressure than ever before,” said Moshe Becker, CEO and Co-Founder of RADLogics. “From extreme pressure on capacity and resources to a major financial strain due to the ongoing COVID-19 pandemic, there is no question that the healthcare system is in need for new solutions such as AI to augment caregivers to alleviate the increased burden and support better outcomes.”

Availability

The application is available immediately through the Nuance
AI Marketplace for Diagnostic Imaging.

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