Echo IQ, the developer of AI-driven medical software to support the diagnosis of heart structural illnesses, has been awarded 510(k) clearance by the US FDA for its EchoSolv software, which aims to help in early diagnosis of severe aortic stenosis.
The company’s software technology has been designed to help clinicians automate the process of identifying aortic stenosis based on AI-powered phenotype analysis and clinical practice guidelines, with an effectiveness of up to 97%. Eco IQ received the approval following an application it made in May 2024.
The company’s AI-powered diagnostic software could help in the early detection of aortic stenosis, which has a high mortality rate of up to 50% in its severe stage. Early detection of the illness could allow for early medical interventions, leading to improved treatment outcomes.
Revolutionizing Aortic Stenosis Detection With AI
Founded in 2010 in Australia, Echo IQ joined the US market just two years ago, providing advanced heart-health diagnostic AI solutions for cardiologists.
Recently, the company raised $4.7 million (A$7.1 m) to support the development of more health-focused diagnostic solutions and fuel its global expansion plans, which include extending its software solutions to more health facilities.
With the FDA’s 510(k) approval, the company will now focus on selling its software solutions to customers in the United States.
Meanwhile, the company has already begun initial talks with a number of healthcare organizations and is exploring licensing deals with pharmaceutical companies and device manufacturers for integration of EchoSolv, according to executive chair Andrew Grover.