YorLabs Achieves Milestone with FDA-Cleared Imaging Device in Cardiology Procedures
YorLabs, Inc., an innovative medical technology company based in Beaverton, Oregon, has announced a groundbreaking achievement in the field of intracardiac imaging. On January 12, 2026, the company released news of the first clinical procedure performed utilizing its FDA 510(k) cleared YorLabs Intracardiac Imaging System. This event marks a significant benchmark in the adoption of high-resolution intraventricular visualization technology that caters specifically to electrophysiology (EP) and interventional cardiology (IC).
The procedure was carried out at the prestigious Oregon Health & Science University (OHSU), a leading academic medical center known for its advanced clinical practices. Under the guidance of Dr. Saket Sanghai and Dr. Firas Zahr, the YorLabs Imaging System facilitated real-time, detailed imaging during an atrial fibrillation ablation procedure, showcasing its capabilities in a functioning clinical environment.
The most notable aspect of the YorLabs platform is its Zero-CapEx design, which allows medical professionals to access high-resolution imaging without the burden of traditional infrastructure costs. This innovative platform integrates smoothly into existing cath lab workflows, ensuring that healthcare providers can operate efficiently without the need for extensive capital investment or complicated setups.
In Dr. Sanghai's words, “This first procedure signals a pivotal change in how intracardiac imaging can be delivered in cath labs. The intuitive design and the high-quality imaging provided by the system make this a valuable addition to our toolkit.” This sentiment is echoed by Dr. Zahr, who highlighted the transformative potential of having state-of-the-art imaging technology available without the typical financial constraints associated with traditional systems.
The YorLabs Intracardiac Imaging System is built on a compact, wireless software-defined architecture, enabling easy single-operator control and advanced imaging across a variety of intracardiac procedures. It is predicted to enhance patient outcomes by simplifying the imaging process and streamlining clinical workflows.
As the demand for high-quality intracardiac echocardiography expands, driven by the necessity for improved visualization and precision in procedures, YorLabs aims to cater to this growing need effectively. The company is dedicated to reducing the complexities and costs related to traditional imaging systems, providing enhanced access to ICE-guided procedures for a broader range of facilities.
Looking ahead, YorLabs plans a limited roll-out of their system in the U.S. market in 2026, followed by a more extensive commercial launch. Clinical partnerships with leading centers of excellence in EP and IC are also in the works, intending to further drive the adoption of their cutting-edge technology.
With a commitment to redefining cardiac imaging through innovative solutions, YorLabs plays a crucial role in advancing healthcare technology to improve patient care. Their vision encompasses making advanced imaging techniques accessible in every cath lab, thereby laying the groundwork for the future of precision therapy in cardiology.
For those interested in learning more about the advancements made by YorLabs, additional details can be found on their website, www.yorlabs.com.
The procedure was carried out at the prestigious Oregon Health & Science University (OHSU), a leading academic medical center known for its advanced clinical practices. Under the guidance of Dr. Saket Sanghai and Dr. Firas Zahr, the YorLabs Imaging System facilitated real-time, detailed imaging during an atrial fibrillation ablation procedure, showcasing its capabilities in a functioning clinical environment.
The most notable aspect of the YorLabs platform is its Zero-CapEx design, which allows medical professionals to access high-resolution imaging without the burden of traditional infrastructure costs. This innovative platform integrates smoothly into existing cath lab workflows, ensuring that healthcare providers can operate efficiently without the need for extensive capital investment or complicated setups.
In Dr. Sanghai's words, “This first procedure signals a pivotal change in how intracardiac imaging can be delivered in cath labs. The intuitive design and the high-quality imaging provided by the system make this a valuable addition to our toolkit.” This sentiment is echoed by Dr. Zahr, who highlighted the transformative potential of having state-of-the-art imaging technology available without the typical financial constraints associated with traditional systems.
The YorLabs Intracardiac Imaging System is built on a compact, wireless software-defined architecture, enabling easy single-operator control and advanced imaging across a variety of intracardiac procedures. It is predicted to enhance patient outcomes by simplifying the imaging process and streamlining clinical workflows.
As the demand for high-quality intracardiac echocardiography expands, driven by the necessity for improved visualization and precision in procedures, YorLabs aims to cater to this growing need effectively. The company is dedicated to reducing the complexities and costs related to traditional imaging systems, providing enhanced access to ICE-guided procedures for a broader range of facilities.
Looking ahead, YorLabs plans a limited roll-out of their system in the U.S. market in 2026, followed by a more extensive commercial launch. Clinical partnerships with leading centers of excellence in EP and IC are also in the works, intending to further drive the adoption of their cutting-edge technology.
With a commitment to redefining cardiac imaging through innovative solutions, YorLabs plays a crucial role in advancing healthcare technology to improve patient care. Their vision encompasses making advanced imaging techniques accessible in every cath lab, thereby laying the groundwork for the future of precision therapy in cardiology.
For those interested in learning more about the advancements made by YorLabs, additional details can be found on their website, www.yorlabs.com.
Topics Health）
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