Resonance Health preparing FDA submission for pulmonary embolism AI alerts

Medical imaging and research company Resonance Health (ASX: RHT) continues to advance a new artificial intelligence solution for automated alerts for patients with a suspected pulmonary embolism (PE), blood clots that block arteries in the lungs. 

The research and development has now led to the Pre-Submission filing of ALERT-PE to the United States Food and Drug Administration where Resonance Health has requested feedback that would enable a formal application. 

Using neural network training on extensive radiology datasets, ALERT-PE reviews CT scans of patients and is intended to assist hospitals and radiologists by flagging and communicating suspected PE pathologies which are frequently missed by human review of the scans. 

PE is part of the venous thromboembolism (VTE) spectrum, which ranges from asymptomatic deep vein thrombosis to fatal PE, and is a blockage of the pulmonary arteries in the lungs caused by blood clots. 

Autopsy studies have shown that approximately 60% of patients who have died in hospital had PE, with the diagnosis having been missed in up to 70% of the cases, highlighting the need for new diagnostic tools. 

Due to the time sensitivity of blood clots in the lungs, Resonance Health considers AI-driven alerts to be highly beneficial to positive patient outcomes to draw immediate attention to cases of suspected PE. 

The FDA pre-submission comes six months after Resonance Health filed a submission to the FDA for HepaFat-AI, their fully automated artificial intelligence (AI) software tool that measures a patient’s liver fat that can be integrated directly into existing radiology workflows.