Why Did Echo IQ’s CPT Code Application Fall Short and What’s Next?
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.
- Category III CPT code application for EchoSolv AS rejected by AMA
- Resubmission planned before June 11 deadline for September review
- Current US usage and technology integration remain unaffected
- Ongoing FDA clearance and partnership developments progressing
- Company confident in reimbursement strategy and subscription model
Echo IQ Faces Regulatory Hurdle in US Market
Echo IQ Limited, an Australian AI-driven medical technology company, has encountered a setback in its efforts to secure a Category III Current Procedural Technology (CPT) code for its EchoSolv AS product in the United States. The American Medical Association’s (AMA) CPT Editorial Panel recently deemed the company’s application unsuccessful, a critical step for reimbursement and wider adoption in the US healthcare system.
Despite this initial rejection, Echo IQ is not deterred. The company is actively engaging with the AMA and reimbursement advisors to address the feedback received and plans to resubmit its application ahead of the June 11, 2025 deadline. This will allow Echo IQ to present its revised submission at the September 2025 panel meeting, aiming to secure the coveted CPT code shortly thereafter.
Maintaining Momentum Amid Challenges
Importantly, Echo IQ assures investors and stakeholders that this regulatory hurdle has not disrupted the current deployment and use of EchoSolv AS across existing US sites. Technology integration efforts continue unabated, and the company’s subscription-based revenue model remains intact. This resilience underscores management’s confidence in their reimbursement strategy and commercialisation roadmap.
CEO Dustin Haines acknowledged the disappointment but framed the outcome as a common part of the regulatory process, emphasizing the value of the AMA’s feedback in strengthening future submissions. Echo IQ is simultaneously advancing FDA clearance for its EchoSolv HF product and pursuing new product development, licensing, and partnership opportunities, all progressing on schedule.
Looking Ahead: Strategic Engagement and Investor Communication
To keep investors informed, Echo IQ has scheduled a webinar on May 23, 2025, where CEO Haines will provide further updates on the CPT application status, US commercialisation strategy, and other initiatives. This transparent communication approach aims to maintain investor confidence and provide clarity on the company’s path forward.
While the CPT code remains a pivotal milestone for Echo IQ’s US market ambitions, the company’s broader strategy appears robust, balancing regulatory navigation with ongoing commercial and technological progress.
Bottom Line?
Echo IQ’s regulatory setback is a temporary detour, not a roadblock, as it refines its US reimbursement strategy.
Questions in the middle?
- What specific feedback did the AMA provide, and how will Echo IQ address it in the resubmission?
- How might the delay in CPT code approval affect revenue projections for the US market?
- What progress is being made on FDA clearance for EchoSolv HF and potential new partnerships?
