Latest EchoIQ (ASX:EIQ) News

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.

Echo IQ has completed a pivotal clinical validation of its EchoSolv HF software at the Mayo Clinic, achieving outstanding accuracy ahead of its FDA submission. This milestone sets the stage for potential US market entry into a $60 billion heart failure diagnostics sector.

Echo IQ Limited has advanced its EchoSolv heart failure solution towards FDA submission, driven by a landmark clinical validation study and a sharp rise in US platform adoption. Strategic partnerships and international expansion efforts underscore the company’s growing footprint in cardiology AI.

Echo IQ’s application for a Category III CPT code was declined by the AMA, but the company is exploring reconsideration and new AI-specific coding frameworks to advance US reimbursement.

Echo IQ reports a remarkable 153% increase in echocardiogram processing through its EchoSolv AS platform in the US, with a Mayo Clinic validation study nearing completion ahead of a critical FDA submission. The company is also advancing European market entry and strengthening its advisory team to accelerate global growth.

Echo IQ has completed its presentation to the CPT Editorial Panel for a Category III CPT code for EchoSolv AS, with a decision expected from the American Medical Association in the coming weeks. Meanwhile, the company is advancing US deployments and FDA clearance efforts.

Echo IQ Limited reported a sharp increase in losses for FY25 despite revenue growth, while securing FDA clearance and expanding its AI-driven cardiology platform across major US networks.

Echo IQ has secured a strategic collaboration with the Mayo Clinic Platform and raised $17.3 million, advancing its AI-driven cardiology tools towards FDA clearance and US commercial scale.

Echo IQ has secured a pivotal reseller agreement with US-based SARC MedIQ, unlocking access to over 300 healthcare facilities and accelerating adoption of its AI-driven EchoSolv AS technology across the American cardiology landscape.

Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.

Echo IQ’s application for a key US procedural code was rejected but the company plans a swift resubmission, maintaining confidence in its US commercial rollout.

Echo IQ has raised $17.3 million through a strongly supported institutional placement to fund US commercialization and FDA approval efforts for its EchoSolv AI cardiology products.