Australian artificial intelligence and medical technology company Echo IQ (ASX:EIQ) has submitted its full and complete US FDA application for market clearance of its proprietary artificial intelligence (AI) backed decision support tool to assist in detecting aortic stenosis.
The tool EchoSolv, a novel machine learning algorithm, was developed by the company using access to cardiac data covering millions of echocardiographic data points.
The company said its application has been developed over the last 12 months and follows a positive pre-submission meeting with the FDA and the completion of a US Reader
"A number of large US healthcare groups have indicated that FDA clearance would mark an important step in their consideration for deployment of the technology, and the Company anticipates that a positive response by the FDA will lead to increased commercial uptake," said Echo IQ.
Executive chairman Andrew Grover said, “The Company’s FDA submission marks a major milestone in its regulatory compliance strategy and concludes an extensive period of clinical studies highlighting the solution’s potential. We are confident that clearance from the regulator, which is expected in 90 days, will unlock a significant opportunity for commercial deployment. Our team has nurtured a robust pipeline of potential customers, laying the groundwork for future growth and success.”