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SpectraWAVE Secures 510(k) Clearance to Add Saline Imaging and Expanded Artificial Intelligence Features to the HyperVue™ Imaging System

September 19, 2023

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.

© 2023 SpectraWAVE. All rights reserved. HyperVue, Starlight, and DeepOCT are commercial trademarks for the SpectraWAVE Imaging System, Catheter, and Image cleared for sale in the U.S.A.
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