YorLabs Receives FDA Clearance for Zero-CapEx Intracardiac Imaging System

October 27, 2025
YorLabs has received FDA 510(k) clearance for its Intracardiac Imaging System, a zero-capex ultrasound platform designed for electrophysiology and interventional cardiology procedures. The system enables single-operator control and offers high-resolution, real-time imaging for cardiac interventions.

YorLabs has received U.S. Food and Drug Administration 510(k) clearance for its Intracardiac Imaging System, announced in a press release. The zero-capex ultrasound platform is designed to simplify workflow and reduce costs in electrophysiology and interventional cardiology procedures.

The system provides high-resolution, real-time imaging and allows single-operator control for a variety of intracardiac procedures. It integrates wirelessly into existing catheterization labs, enabling flexible deployment without requiring major equipment investments.

YorLabs said it plans a limited U.S. market release in 2026, followed by broader commercial rollout and clinical collaborations with leading centers in electrophysiology and interventional cardiology.

We hope you enjoyed this article.

Consider subscribing to one of our newsletters like Life AI Weekly or Daily AI Brief.

Also, consider following us on social media:

Healthcare & Life Sciences AI AI Brief AI Brief (X)

More from: Life Sciences

10/27
Region Stockholm Consolidates Hospital Imaging in Sectra Cloud System
10/27
Mumtalakat Partners with SandboxAQ to Build Bahrain’s Biotech Ecosystem
10/27
ChemDiv Extends Partnership with Mondego Bio on PTPN2 Immuno-Oncology Program
10/27
Northwest Biotherapeutics Closes Acquisition of Advent BioServices
10/27
MindHYVE.ai Partners with PIHS to Deploy AI in Education and Healthcare in Pakistan

Subscribe to Life AI Weekly

Weekly coverage of AI applications in healthcare, drug development, biotechnology research, and genomics breakthroughs.

AI Token Webinar

Whitepaper

Stanford HAI’s 2025 AI Index Reveals Record Growth in AI Capabilities, Investment, and Regulation

The 2025 AI Index by Stanford HAI provides a comprehensive overview of the global state of artificial intelligence, highlighting significant advancements in AI capabilities, investment, and regulation. The report details improvements in AI performance, increased adoption in various sectors, and the growing global optimism towards AI, despite ongoing challenges in reasoning and trust. It serves as a critical resource for policymakers, researchers, and industry leaders to understand AI's rapid evolution and its implications.

Read more

You May Also Like