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Cranfield, UK, 30th July 2024 – Personal ECG vendor AliveCor announced a major milestone this month, with the news that its Kardia 12L ECG System, only given FDA approval in June, has been granted new CPT Category III Codes by the American Medical Association (AMA). The new codes, effective from 1st January 2025, will cover:
- 0903T Electrocardiogram, algorithmically generated 12-lead ECG from a reduced-lead ECG; with interpretation and report
- 0904T ECG ALG 12 algorithmically generated 12-lead ECG from a reduced-lead ECG; tracing only
- 0905T Electrocardiogram, algorithmically generated 12-lead ECG from a reduced-lead ECG; interpretation and report only
According to AliveCor, its Kardia 12L ECG System is the world’s first AI-powered, handheld 12-lead ECG system with a single-lead design that can detect ‘life-threatening conditions, including heart attacks’. AliveCor is also keen to emphasise that Kardia 12L has been designed, from a form factor and workflow perspective, for ‘resource-limited or rural settings’. Its KardiaStation app guides users in selecting one of two lead set placement options depending on the patient’s symptoms. Due to its reduced lead-set, patients do not need to fully disrobe during a reading and all ECG recordings are automatically uploaded to AliveCor’s KardiaPro web portal. KardiaPro can also be paired with the company’s QT Screening solution, KardiaStation.
The Signify View
AliveCor has been one of the lead disruptors in the Diagnostic Cardiology market since its founding in 2010, having released a range of personal ECG devices for the healthcare and consumer markets. Signify Research has previously written about the multiple partnerships (often including funding) the company has entered into with major healthcare technology vendors, including Biotronik and Omron. A partnership with GE HealthCare, announced in late 2022, saw the integration of its KardiaMobile 6L device with GE HealthCare’s market-leading ECG Management System, Muse.
This latest development represents a step-change for AliveCor on a number of levels. Firstly, Kardia 12L is the first AliveCor product that has been developed exclusively for use by healthcare professionals, unlike its existing portfolio of personal ECG devices which cover the direct-to-consumer, payor, employee, and life sciences markets (it’s Kardia 6L device, while used by providers, is also available over the counter and as part of payor and employee programmes).
The granting of CPT codes feels particularly significant in this regard, as fee-for-service-based reimbursement is still a critical enabler of technology adoption. This is especially so in the resource-constrained healthcare settings for which Kardia 12L has been designed. These settings, for various reasons, have been slower to implement the value-based models of care that incentivise the adoption of new technologies. It also follows on from previous AI-ECG-related CPT Category III codes granted to Anumana in July 2022, and Vektor Medical in October 2023.
That said, it should be noted that all Category III CPT codes require further study and evaluation before becoming eligible for standard billing (Category I), a process which can take up to five years. Even with a limited reimbursement regime in place, rapid adoption will be far from guaranteed. For example, a study published in late 2023 revealed that, between January and June 2023, only 435 claims were made for Anumana’s AI-ECG related CPT Codes. Those caveats aside, it is still a promising development which should encourage further progress.
Expanding the Toolbox
Despite recent advances in ambulatory cardiology devices, the traditional 12-lead Resting ECG is still considered ‘the Gold Standard’ and the de facto first point on the clinical pathway for millions of cardiac patients. However, rural or other resource-poor healthcare settings can lack the basic hardware, clinical specialists, and integrations with larger ECG management systems to fully leverage the diagnostic potential of a 12-lead ECG reading. Even in the most advanced health systems, 12-lead ECG readings have, until very recently, been restricted to diagnosing arrythmias, with costly imaging procedures required to diagnose other cardiovascular conditions.
In combining a smaller, more portable and user-friendly 12-lead ECG device with enhanced analytical capabilities, Kardia 12L offers a potential solution to many of these issues. For the short-to-medium term at least, it will also complement, rather than directly compete with, other recent advances in the Resting ECG market. For example, while several AI-ECG vendors have developed algorithms to detect structural heart conditions (including Anumana, Powerful Medical, and Viz.ai), these algorithms currently interpret signals from traditional 12-lead Resting ECG devices. The lack of these devices in remote healthcare settings being the very problem for which Kardia 12L has been developed as a solution.
This may change as more ECG modalities enter the market, such as HeartBeam’s AIMIGo or HeartSciences’ MyoVista AI-powered devices, and more vendor partnerships are announced. Anumana’s recently announced partnership to integrate its ECG-AI LEF algorithm into InfoBionic.Ai’s continuous and remote cardiac monitoring platform being an example of the latter.
That said, AliveCor’s existing partnerships with industry heavyweights such as Omron and GE HealthCare should continue to open doors for the company. With existing AliveCor integrations with GE HealthCare’s Muse ECG Management System, one would assume something is being worked on in the background with Kardia 12L. Alternative solutions and partnerships may be required for health systems lacking high-end (or any) ECG Management Systems. With vendors and providers alike now placing a high premium on interoperability, these partnerships should, in theory, be achievable (all the usual provisos around healthcare aside).
What benefits AliveCor can draw from its relationship with Omron will also be worth tracking. Omron, which first invested in AliveCor back in 2017, has been undergoing something of a digital transformation itself of late, though it still retains a strong footprint in acute and primary care settings courtesy of its range of non-invasive blood pressure (NIBP) monitors. The two companies have also previously developed a combined ECG/NIBP device.
Final Thoughts
AliveCor has form when it comes to disruptive technologies in the Diagnostic Cardiology market that complement, rather than directly compete with existing vendor’s solutions. Kardia 12L appears to be a continuation of this though, significantly, it is the first solution AliveCor has released specifically targeting healthcare providers.
Echoing sentiments of clinicians, MedTech companies, and industry analysts alike, there is no silver bullet (or should that be scalpel?) when it comes to healthcare. That said, this latest development has the potential to significantly expand the range of tools available to cardiologists in the ongoing battle with cardiovascular disease.
Related Research
Signify Research recently published ‘Diagnostic Cardiology – World – 2024’, the third iteration of its global market report on the Diagnostic Cardiology Market. The report provides a quantitative overview of the market, including 5-year forecasts, and analysis of the key regional market drivers and barriers. Signify Research also published ‘AI in Diagnostic Cardiology ECG – World – 2023’, in December 2023. The report provides an in-depth, qualitative overview of the key technological and market trends, including detailed profiles of key vendors in the market.
About The Author
Gareth joined Signify Research in 2021 as Senior Market Analyst in the Digital Health team, where he covered emerging markets including Remote Patient Monitoring (RPM) and Ambulatory Diagnostic Cardiology. In 2023, Gareth joined Signify’s Clinical Care team where, his coverage areas include Diagnostic Cardiology and Patient Monitors.
About the Clinical Care Team
The clinical care team provides market intelligence and detailed insights on the clinical care equipment and IT markets. Our areas of coverage include patient monitoring, diagnostic cardiology, infusion pumps, ventilators, anaesthesia devices, and high-acuity IT. Our reports provide a data-centric and global outlook of each market with granular country-level insights. Our research process blends primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.
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