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Uncategorized

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 Appoints Eman Namati, Ph.D., as Chief Executive Officer to Lead Development and Launch of Flagship Technology

October 9, 2020
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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.

© 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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