Conavi Medical submits Novasight Hybrid IVUS/OCT System to FDA for 510(k) clearance

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Conavi Medical has submitted its Novasight Hybrid IVUS/OCT intravascular imaging system to the US Food and Drug Administration (FDA) for 510(k) clearance for coronary applications.

While optical coherence tomography (OCT) is traditionally used to monitor retinal diseases, it has been adapted for use to look for the presence of coronary artery stenosis (CAS),² cardiovascular disease (CVD) risk assessment,³ improving breast cancer surgeries, reducing the number of patients requiring repeat surgery, and more.⁴ Providers in cardiology, neurology, oncology, and other fields have also found useful ways to integrate OCT imaging into their practices, underscoring a growing trend of cross-disciplinary innovation.

Conavi’s proprietary hybrid intravascular imaging platform combines both intravascular ultrasound (IVUS) and OCT into a single integrated system, the first to do so. This dual-modality approach is designed to provide cardiologists with a comprehensive view of coronary arteries, potentially enabling more precise diagnosis and treatment of cardiovascular disease.

Tom Looby, CEO of Conavi Medical, commented on the FDA submission, saying, “With our pilot system already cleared by the FDA, we feel that this submission leverages a strong regulatory foundation and may provide for an efficient review process. We believe the next-generation Novasight Hybrid system is well positioned to capitalize on the growing adoption of intravascular imaging, a category that has been shown to improve procedural outcomes during coronary interventions.”

According to the company, key advancements included in its Novasight Hybrid system include enhanced IVUS and OCT image quality, a simplified user interface with added software features for improving ease of use, a system redesign to improve cath lab workflow including system setup and bedside control, and a design focused on reliability and robustness for routine clinical use.

The first-generation Novasight Hybrid System has regulatory clearance in the US, Canada, China, and Japan.

References:

1. Conavi Medical Submits Next Generation Novasight Hybrid Intravascular Imaging System to US FDA for 510(k) Clearance. Published September 16, 2025. Accessed September 22, 2025. https://www.globenewswire.com/news-release/2025/09/16/3150646/0/en/Conavi-Medical-Submits-Next-Generation-Novasight-Hybrid-Intravascular-Imaging-System-to-US-FDA-for-510-k-Clearance.html

2. Charters L. Retinal microvasculature on OCTA may predict coronary artery disease risk. Published July 30, 2025. Accessed September 22, 2025. https://www.ophthalmologytimes.com/view/retinal-microvasculature-on-octa-may-predict-coronary-artery-disease-risk

3. Hayes H. Heart Eye announces AI-driven retinal imaging system to detect biomarkers of cardiovascular health risks. Published February 21, 2025. Accessed September 22, 2025. https://www.ophthalmologytimes.com/view/heart-eye-announces-ai-driven-retinal-imaging-system-to-detect-biomarkers-of-cardiovascular-health-risks

4. Harp MD. From eye care to cancer care: Expanding role of OCT imaging. Published November 27, 2024. Accessed September 22, 2025. https://www.ophthalmologytimes.com/view/from-eye-care-to-cancer-care-expanding-role-of-oct-imaging