Gentuity, LLC

Gentuity, LLC is a medical device manufacturer specializing in next-generation intravascular imaging solutions for interventional cardiology. The company's core product is the HF-OCT™ Imaging System, a high-frequency optical coherence tomography platform designed for percutaneous coronary intervention (PCI) guidance and coronary artery disease assessment. The system integrates with the Vis-Rx® PRIME Micro-Imaging Catheter, an ultra-low-profile (1.8F) device enabling access to small, tortuous, and complex coronary vessels. Key clinical capabilities include rapid full-length vessel imaging in a single pullback, saline-compatible imaging, and real-time visualization for procedural optimization. The HF-OCT system features plug-and-play integration into catheterization laboratory workflows without requiring sterile barriers. Gentuity's products target interventional cardiologists performing complex PCI procedures, with distribution partnerships including GE HealthCare (United States), Nipro Medical Europe (EMEA), and Nipro Japan. The company holds regulatory clearance documentation including Summary of Safety and Clinical Performance (SSCP) and maintains DICOM conformance standards. Marketing emphasizes clinical case studies demonstrating utility in challenging anatomies, including critically narrow lesions and calcified vessels. The company actively participates in major interventional cardiology conferences (TCT, EuroPCR, SCAI) and publishes peer-reviewed clinical evidence.