Sam Brusco, Associate Editor12.06.23
Bering Limited, a London-based medical artificial intelligence (AI) company, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest X-ray triage solution, BraveCX.
BraveCX is a radiological computer-assisted triage and notification software that analyzes adult chest X-rays for presence of pre-specified, suspected clinical findings. It triages and prioritizes emergency cases like plural effusion and pneumothorax immediately after the exam. The physician is then notified, offering a second opinion and reducing the time-to-diagnosis of urgent cases, Bering claimed.
The company said BraveCX was developed on over a million chest X-rays from diverse clinical settings and fine-tuned with more than 50,000 chest X-rays labeled by board-certified radiologists. It has shown 95-97% specificity and ROC AUCs of 0.96 and 0.98 of pleural effusion and pneumothorax respectively.
Bering plans to roll the product out with a flexible deployment model of a cloud-based service, directly on premises, or integrated with chest X-ray hardware systems.
Bering founder and CEO Dr. Ignat Drozdov told the press, "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 prioritizes patient safety, whilst still delivering the most advanced Risk Stratification algorithms where they are needed the most."
BraveCX is a radiological computer-assisted triage and notification software that analyzes adult chest X-rays for presence of pre-specified, suspected clinical findings. It triages and prioritizes emergency cases like plural effusion and pneumothorax immediately after the exam. The physician is then notified, offering a second opinion and reducing the time-to-diagnosis of urgent cases, Bering claimed.
The company said BraveCX was developed on over a million chest X-rays from diverse clinical settings and fine-tuned with more than 50,000 chest X-rays labeled by board-certified radiologists. It has shown 95-97% specificity and ROC AUCs of 0.96 and 0.98 of pleural effusion and pneumothorax respectively.
Bering plans to roll the product out with a flexible deployment model of a cloud-based service, directly on premises, or integrated with chest X-ray hardware systems.
Bering founder and CEO Dr. Ignat Drozdov told the press, "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 prioritizes patient safety, whilst still delivering the most advanced Risk Stratification algorithms where they are needed the most."