October 2025 issue, BioElectRx Business Report
October 31, 2025 | This newsletter often covers the development of diagnostic devices that help identify disease severity and select suitable candidates for bioelectronic medicine therapies. A case in point is the use of cervical VNS for treating heart failure with reduced ejection fraction. Several clinical trials for HFrEF led by BioControl Medical, Boston Scientific, and LivaNova failed their primary endpoints, even though they were successful for a subset of patients.
According to Jeff Ardell, the UCLA cardiac neuromodulation pioneer who passed away earlier this year, the heterogeneity of HFrEF patients was a significant contributor to these failures. This is because patients experience HFrEF from various causes, which can range from ischemic coronary arteries (due to coronary artery disease or myocardial infarction) to heart hypertrophy, hypertension, and malfunctioning heart valves.
Ejection fraction is often measured using echocardiography, but this technique has limitations, including when measuring many other hemodynamic parameters such as pulmonary artery and wedge pressures or cardiac output, making it unsuitable for confirming the presence of HFrEF. Presently, invasive right heart catheterization is considered the gold standard for hemodynamic assessment due to its ability to measure direct pressures. This is a hospital-based cardiac procedure whereby ejection fraction is measured by injecting a contrast dye into the heart’s left ventricle followed by angiography. The development of simpler diagnostic tools for confirming HFrEF is, therefore, a key bottleneck in selecting candidates for bioelectronic medicine therapies and in monitoring therapy progress.
This situation may be about to change soon. Last month, the American Medical Association accepted a new temporary CPT code X486T for noninvasive augmentative AI hemodynamic assessment. If you are wondering why the CPT code was issued by the AMA and not the Centers for Medicare & Medicaid Services, it relates to their division of labor. While CMS issues HCPCS codes for most products and supplies, the AMA issues CPT codes for diagnostic services and therapeutic procedures. CMS (and commercial payers) then determines coverage and payment for both the CPT and HCPCS codes.
One of the first beneficiaries of this code will be Sensydia. The Los Angeles company is currently developing a novel diagnostic device for hemodynamic assessment. This device should be able to help differentiate between various causes of HFrEF by assessing cardiac output, pulmonary artery pressure, pulmonary artery occlusion pressure, and ejection fraction.
The best part about this technology is its use of augmentative AI, which analyzes various heart parameters to provide a clinically meaningful output and differential diagnosis. While a physician is still required for the final interpretation, the overall process is considerably faster than scheduling a patient for a cath lab to perform an invasive right and/or left heart catheterization. In contrast, Sensydia’s device can be used in an outpatient clinic by general cardiologists, does not require hospital facilities, and saves precious time between referral and testing. This is particularly important for high-risk patients who may require immediate therapy.
Details about this new CPT code will be published by the AMA in January 2026, and the code will become effective on July 1, 2026. After that, Sensydia will engage with payors to seek coverage and payment. Meanwhile, Sensydia is conducting their pivotal study, the results of which will be included in their FDA submission for the Cardiac Performance System. “We are very pleased that this new CPT code is on its way to becoming effective in 2026, as it constitutes an important first step toward reimbursement as we work to bring CPS to market,” said Anthony Arnold, CEO of Sensydia.
Looking even further ahead, the availability of devices for AI-assisted hemodynamic assessment may revive efforts toward developing VNS therapies to address the vast and underserved HFrEF market.
