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SpectraWAVE, Inc.
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SpectraWAVE, Inc.
  • Home
  • Products
    • HyperVue Imaging System
    • X1-FFR
  • About Us
  • News
  • Contact

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

September 19, 2023
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SpectraWAVE Secures 510(k) Clearance of HyperVue™ Intravascular Imaging System

March 1, 2023
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SpectraWAVE Expands Company Leadership, Appointing Two New Vice Presidents to Executive Team

November 2, 2021
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SpectraWAVE Announces $13.2 Million Series A-2 Financing from Existing Investors to Bring Imaging Technology to Market

February 3, 2021
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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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