The US Food and Drug Administration (FDA) has cleared the YorLabs Intracardiac Imaging System, an intracardiac echocardiography (ICE) platform designed to meet the rising demand for the imaging modality in cath labs during electrophysiology procedures such as pulsed-field ablation (PFA).
Yorlabs’ platform offers practitioners single operator-controlled, high-resolution, real-time imaging for a broad range of intracardiac procedures. The Oregon-based company designed the device as a wireless and compact system to overcome more expensive and harder to integrate legacy systems.
Related: Alife Health’s AI embryo selection tool Embryo Predict gains CE mark
YorLabs’ CEO, Gregory D Casciaro asserted that the new system delivers the same performance as more capital-intensive platforms yet can be integrated with existing procedural workflows in a “simpler, smarter, and more accessible” way.
ICE systems’ provision of real-time imaging from inside the heart are particularly useful for visualising key targets such as pulmonary veins, left atrium, and posterior wall during PFA procedures.
Growing at a CAGR of 4.9%, the electrophysiology lab systems market, which encompasses ICE systems, is projected to be worth around $1.2bn by 2034, up from $744m in 2024.
The growing demand in the market is largely attributable to the recent entry of some of medtech’s largest players into the PFA space. Boston Scientific, Medtronic, and Johnson & Johnson (J&J) all now have PFA system available on the US market, with the companies receiving FDA clearance on their systems in January 2024, December 2023, and November 2024, respectively.
Each company has reported significant uplifts in their medtech portfolio revenues in their recent financial quarters, as market adoption of their respective Farapulse, PulseSelect, and VariPulse PFA systems in the US continues.
Boston’s Q3 2025 cardiovascular portfolio revenues exceeded $3.3bn, indicative of a 22.4% rise from $2.7bn in Q3 2024. During a post-earnings conference call, Boston’s CEO Mike Mahoney shared that 500,000 patients to date have been treated with Farapulse.
In Q1 FY26, Medtronic’s cardiovascular segment achieved profits of $3.28bn, reflecting growth of 9.3% from around $3bn compared to the same period in the previous fiscal year. J&J MedTech grew to around $8.4bn in Q3 2025, reflecting a 5.6% uplift on the same period in 2024.
According to GlobalData analysis, the electrophysiology ablation catheter market, which includes PFA systems, is forecast to reach a valuation of around $16.7bn by 2034, up from $4.9bn in 2024.
