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SpectraWAVE Receives 510(k) Clearance for X1-FFR, an AI-enabled, Wire-Free, Drug-Free, Single Angiogram Physiology Solution

October 21, 2025

SpectraWAVE
12 Oak Park Drive Bedford, MA 01730 US
855-DEEP-OCT info@spectrawave.com

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Indications for Use

The HyperVue Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The Starlight Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.
The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.
The NIRS capability of the HyperVue Imaging System is intended for the detection of lipid-core containing plaques of interest.
The NIRS capability of the HyperVue Imaging System is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the HyperVue Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
The SpectraWAVE X1-FFR Software features segmentation of coronary vessels, and measurement and reporting tools to facilitate the following use: Calculate the dimensions of coronary vessels; Quantify stenosis in coronary vessels; Quantify pressure drop in coronary vessels
The SpectraWAVE X1-FFR Software is intended to be used by or under the supervision of a cardiologist

© 2025 SpectraWAVE. All rights reserved. HyperVue, Starlight, DeepOCT, and X1 are commercial trademarks for SpectraWAVE’s Imaging System, Catheter, Image, and Software cleared for sale in the U.S.A.
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