News | Artificial Intelligence | 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.

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.

December 8, 2023 — Bering Limited, a London-based medical AI company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest X-Ray triage solution, ‘BraveCX’. 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’s BraveCX is a radiological computer-assisted triage and notification software that analyzes adult (≥18 years old) chest X-ray (CXR) images for the presence of pre-specified suspected clinical findings. The product was designed to triage and prioritize emergency cases such as pleural effusion and pneumothorax immediately after the exam. Findings are notified to the physician, providing a “second opinion” and reducing the time-to-diagnosis of urgent cases.

The product was developed on over 1,000,000 CXRs acquired across diverse clinical settings and further fine-tuned with over 50,000 CXRs labeled by board-certified radiologists. BraveCX shows excellent performance of 95%-97% specificity and ROC AUCs of 0.96 and 0.98 on pleural effusion and pneumothorax respectively.

The FDA clearance allows the company to accelerate its sales expansion in the U.S. market. Using a flexible deployment model of a cloud-based service, directly on premises, or integrated with CXR hardware systems, Bering can leverage new and existing partnerships to rapidly bring this device to market.

Dr. Ignat Drozdov, CEO and founder of Bering said: “After over three years of research and collaboration with clinical teams, it’s so exciting to see BraveCX emerge as a state-of-the-art tool that has actually ‘listened to the end user’. FDA clearance means BraveCX prioritises patient safety, whilst still delivering the most advanced Risk Stratification algorithms where they are needed the most.”

For more information: https://beringresearch.com/


Related Content

News | Radiology Imaging

Feb. 12, 2026 — Siemens Healthineers and Mayo Clinic are expanding their strategic collaboration to enhance patient care ...

Time February 13, 2026
arrow
News | Digital Pathology

Feb. 11, 2026 — Leica Biosystems has announced the global launch of the Leica CM1950 Cryostat with DualEcoTec Cooling ...

Time February 11, 2026
arrow
Feature | Radiology Imaging | Paul Mott

Hospitals across the U.S. are facing a growing crisis that hits right at the heart of patient care: There simply aren’t ...

Time February 10, 2026
arrow
Feature | Cardiac Imaging | Kyle Hardner

Advances in coronary CT angiography (CCTA) have reached the point where image quality and AI capabilities are creating ...

Time February 06, 2026
arrow
News | Magnetic Resonance Imaging (MRI)

Feb. 5, 2026 — Eyas Medical Imaging, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ...

Time February 06, 2026
arrow
News | Ultrasound Women's Health

Feb. 5, 2026 — BrightHeart, a global provider of AI-driven prenatal ultrasound, has announced the availability of its B ...

Time February 05, 2026
arrow
News | Lung Imaging

Feb. 3, 2026 — RevealDx, a leader in the characterization of lung nodules, recently announced FDA clearance of RevealAI ...

Time February 04, 2026
arrow
News | FDA

Jan. 29, 2026 — GE HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MIM ...

Time February 03, 2026
arrow
News | Interventional Radiology

Feb. 2, 2026 — GE HealthCare has announced that Allia Moveo has received U.S. Food and Drug Administration (FDA) 510(k) ...

Time February 02, 2026
arrow
News | Radiology Imaging

Jan.26, 2026 — SimonMed Imaging has unveiled an updated brand and the launch of SimonMed Longevity, a new division ...

Time January 27, 2026
arrow
Subscribe Now