|
Echo IQ Limited has successfully completed the clinical validation of its AI-driven software EchoSolv HF, in collaboration with the Mayo Clinic Platform “Validate” program. The study analysed approximately 17,000 independent echocardiograms and delivered exceptional performance — achieving a sensitivity of 99.5% and a specificity of 91.0%. With this milestone now achieved, Echo IQ is preparing to lodge a formal submission for clearance via the U.S. Food & Drug Administration (“FDA”) 510(k) pathway. The implications are significant: heart failure continues to be under-diagnosed (with only ~50 % of cases accurately identified) and carries major financial and clinical burdens in the U.S. (accounting for 17 % of healthcare expenditure and a total addressable market estimated at US$60 billion). EchoSolv HF, once FDA cleared, will leverage Echo IQ’s existing U.S. footprint to support clinicians in earlier, more accurate detection of heart failure — with the potential to disrupt heart failure care pathways and improve patient outcomes. Source https://announcements.asx.com.au/asxpdf/20251124/pdf/06sd55wtxmcnpj.pdf Comments are closed.
|