YorLabs has announced the successful completion of the first clinical procedure using its US Food and Drug Administration (FDA) 510(k)-cleared intracardiac imaging system.
The procedure marks the first real-world clinical use of YorLabs’ Zero-CapEx imaging platform following US FDA clearance. The YorLabs platform currently provides high-resolution 2D intracardiac echocardiography (ICE) imaging, and the company is actively developing 4D ICE capabilities as part of its product roadmap.
The procedure was conducted at Oregon Health & Science University (OHSU) by Saket Sanghai and Firas Zahr using the YorLabs system to provide real-time intracardiac visualisation during an atrial fibrillation (AF) ablation procedure. The system delivered high-resolution imaging under single-operator control and integrated seamlessly into the existing cath lab workflow without requiring additional capital expenditures.
“This first procedure represents an important step forward for how intracardiac imaging can be delivered in the cath lab,” said Sanghai. “The system was intuitive to use, fit naturally into our workflow, and provided the image quality needed to confidently guide the procedure.”
“Having access to high-quality intracardiac imaging without the constraints of traditional capital equipment is compelling,” added Zahr. “This new platform has the potential to broaden access to ICE-guided procedures while reducing complexity for physicians and care teams.”
“This milestone demonstrates that our platform performs as designed in the clinical environment,” said Gregory D Casciaro, president and chief executive officer of YorLabs. “Completing our first procedure at a leading academic medical centre like OHSU so soon after FDA clearance reinforces our belief that intracardiac imaging can be simpler, more accessible, and better aligned with how physicians practice today.”
