Artificial Intelligence and Medical Technology company Echo IQ (ASX:EIQ) has made a number of significant advancements in its strategy to establish a clear pathway to regulatory compliance in its priority target markets.
Echo IQ is conducting a Reader Study in the US to assess diagnostic accuracy and clinical performance for its EchoSolv technology in support of its application for FDA clearance. The Company advises that enrolment of the patient (studies) and clinical readers for the study has been fully completed and the study has now commenced.
This study, being conducted in a US hospital, is expected to form part of the Company’s final FDA 510(k) application.
The study protocols have been developed to comply with the FDA’s routine evaluation of clinical decision support software. This approach uses MRMC (Multiple Reader, Multiple Case) studies for computer-assisted diagnosis devices and aims to evaluate the performance and effectiveness of such systems.
Completion of the reader study is expected to take approximately 80 days, following which Echo IQ expects to submit its final FDA 510(k) application. The FDA currently publicises its timeframe for decision response as being a further 90 days from lodgement of final application.
On successful achievement of FDA clearance, the company has prioritised seeking to obtain New Technology Add-On Payment (NTAP) designation from the US Centres for Medicare and Medicaid Services (CMS).
NTAP designation would permit customers of EchoSolv to obtain reimbursement of usage costs, to a defined limit of the lesser of 60% of the cost of the underlying service or US$1040, and would be expected to accelerate wide-spread usage of the solution in hospital environments.
The company’s advisors have indicated that EchoSolv meets the key criteria for NTAP.
“Initial commercial uptake of EchoSolv has commenced and we continue to advance engagement with leaders in the valve, pharma, hardware and software and reporting sectors,” Executive Chair, Andrew Grover, said.
“The important steps towards US regulatory clearance we are announcing, along with the decision to prioritise NTAP designation, support both the roll-out of our fully AI-enabled suite of solutions for aortic stenosis and increase the speed with which we can deploy EchoSolv in a large range of healthcare facilities.
“Echo IQ remains focused on delivering a solution that is robust, effective and meets the needs of the cardiology community in a manner that is tested, safe and recognised by leading regulators internationally.”