Products

X1-FFR
SpectraWAVE, Inc.
Cardiology AI
X1-FFR delivers rapid, accurate physiology results from a single angiogram—without wires, drugs, or delays, utilizing AI-enabled workflows for automated vessel segmentation and rapid analysis.

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About SpectraWAVE

SpectraWAVE is a medical device company specializing in advanced intravascular imaging and physiological assessment technologies, primarily focused on improving the treatment and outcomes for patients with coronary artery disease (CAD). Their flagship product, the HyperVue™ Imaging System, is an AI-enabled platform that integrates next-generation DeepOCT™ (Optical Coherence Tomography) and Near-Infrared Spectroscopy (NIRS). This combination provides interventional cardiologists with comprehensive optical and computational insights into plaque morphology, composition, and vessel anatomy, aiding in optimal stent intervention and identifying plaques at risk of future coronary adverse events.

Beyond imaging, SpectraWAVE has developed the X1-FFR software, an AI-enabled, wire-free, drug-free solution that provides fractional flow reserve (FFR) assessment from a single angiogram. This technology aims to simplify and accelerate FFR results, eliminating the need for invasive pressure wires and streamlining workflows in the cardiac catheterization lab. The company’s innovations are designed to enhance clinical decision-making, optimize percutaneous coronary intervention (PCI) procedures, and ultimately improve patient care by offering simpler, faster, and better imaging and physiological assessment.

As of December 2025, SpectraWAVE was acquired by Royal Philips, further integrating its breakthrough, AI-powered technologies into Philips’ image-guided therapy portfolio to expand options for clinicians in the cath lab.

Focus Areas

Intravascular imaging Coronary Artery Disease (CAD) Optical Coherence Tomography (OCT) Near-Infrared Spectroscopy (NIRS) AI-enabled image analysis Fractional Flow Reserve (FFR) PCI optimization Diagnostic photonic imaging Medical devices

Business Intelligence

Key InvestorsDeerfield Management, Johnson & Johnson Innovation (JJDC), S3 Ventures, Lumira Ventures, SV Health Investors, Nova Venture Partners, LLC, Heartwork Capital
AcquisitionsAcquired by Philips (December 2025)
TechnologyHyperVue Imaging System (DeepOCT™ + NIRS), X1-FFR (AI-enabled, wire-free, drug-free, single angiogram physiology solution), AI-based image analysis and automated measurements, Image co-registration with angiography
FDA Clearances5 cleared products (estimated)

What Physicians Need to Know

Intravascular Imaging Platform
SpectraWAVE's HyperVue Imaging System integrates DeepOCT (next-generation Optical Coherence Tomography) and NIRS (Near-Infrared Spectroscopy) into a single platform for comprehensive coronary artery imaging.
Advanced Plaque Characterization
The DeepOCT+NIRS combination provides high-resolution structural images with enhanced depth penetration and simultaneously identifies lipid-core containing plaques, crucial for assessing vulnerable plaques and guiding treatment decisions.
AI-Enabled Image Analysis
The system features AI-powered automated quantitative analysis, including lumen and external elastic lamina (EEL) detection, lipid core detection, calcium assessment (thickness, arc, longitudinal measurements), and stent analysis, streamlining image review and decision-making.
Wire-Free Fractional Flow Reserve (FFR)
SpectraWAVE's X1-FFR is an AI-enabled, angiography-derived physiology solution that calculates FFR from a single coronary angiogram, eliminating the need for pressure wires, vasodilator drugs, and network-based DICOM file transfers, leading to rapid and simplified procedures.
PCI Optimization
The combined imaging and physiology data, along with AI-driven insights, empower interventional cardiologists to optimize Percutaneous Coronary Intervention (PCI) procedures, improving stent placement accuracy and overall patient outcomes.
Efficient Workflow
The HyperVue system offers rapid image acquisition (100mm pullback in less than 1 second), low or no contrast imaging with saline compatibility, and a no-flush prep catheter, designed to streamline cath lab procedures and minimize patient exposure.
Physician Tip

For physicians, SpectraWAVE's integrated HyperVue Imaging System with DeepOCT+NIRS and the X1-FFR software offers a powerful diagnostic hub for coronary artery disease. This platform provides unparalleled insights into plaque morphology and composition, enabling more precise and personalized treatment strategies. The AI-enabled automated analysis significantly reduces interpretation time and variability, while the wire-free FFR streamlines workflow, enhances patient comfort, and accelerates decision-making in the cath lab. Leveraging this technology can lead to optimized PCI outcomes, reduced adverse events, and improved long-term patient prognosis by providing a more complete picture of the coronary vasculature. The ability to visualize the entire arterial wall and accurately detect lipid-rich plaques and calcium is particularly valuable for identifying high-risk lesions and guiding stent selection and deployment.

SpectraWAVE has been acquired by Philips. Their HyperVue Imaging System and X1-FFR technology are being integrated into Philips' existing intravascular imaging and physiology ecosystem, including the Eagle Eye Platinum digital IVUS, IntraSight technologies, and the Azurion image-guided therapy platform. This integration aims to expand clinicians' intravascular imaging toolbox and offer a comprehensive, orchestrated system for tailored guidance in coronary interventions.

Products by SpectraWAVE

1 product in the directory

X1-FFR
SpectraWAVE, Inc.
Cardiology AI
X1-FFR delivers rapid, accurate physiology results from a single angiogram—without wires, drugs, or delays, utilizing AI-enabled workflows for automated vessel segmentation and rapid analysis.

What the Web Says

SpectraWAVE is a medical imaging company that develops innovative technologies for coronary care, including the HyperVue Imaging System and X1-FFR for angiogram-derived physiology. While their products are praised by healthcare professionals for their advanced features and ease of use, employee reviews paint a mixed to negative picture of the company culture.

Overall: Mixed

Strengths

  • Advanced imaging and physiology technologies (DeepOCT, NIRS, X1-FFR).
  • AI-enabled workflows for simplified and faster results.
  • Wire-free and drug-free physiology measurements.
  • Single angiogram per vessel for accurate FFR values.
  • Easy-to-use system with positive clinical and early commercial feedback.
  • Competitive salaries in engineering and research & development departments.

Limitations

  • Extremely toxic workplace culture.
  • Harassment and discrimination are reportedly tolerated or encouraged.
  • Lack of adequate human resources support.
  • Management prioritizes profits over employee well-being.
  • Leadership team primarily focused on money, with reports of degradation and threats.
  • Lower salaries in administration and plant/manufacturing departments.

Based on reviews from: Zippia, Diagnostic and Interventional Cardiology, FDA OKs SpectraWAVE's AI-Powered Angiogram Physiology Software, Business Wire, SpectraWAVE, Inc. | Medical Imaging | United States, First-in-Human Experience With a Novel Multimodality DeepOCT-NIRS Intracoronary Imaging System - PMC

Last updated: 2026-07-19

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Press & Coverage

Imaging Technology News
Philips Enters Agreement to Acquire SpectraWAVE
Royal Philips has agreed to acquire SpectraWAVE, an innovator in enhanced vascular imaging and AI-enabled angiography-based physiology assessments, to expand its image-guided therapy portfolio. The acquisition aims to integrate SpectraWAVE's HyperVue Imaging System and X1-FFR technology with Philips' Azurion platform to improve coronary artery disease treatment.
2025-12
Applied Radiology
Philips to Acquire SpectraWAVE, Expanding AI-Driven Coronary Imaging and Physiology Portfolio
Philips announced its agreement to acquire SpectraWAVE, a Massachusetts-based company specializing in advanced intravascular imaging and AI-powered physiological assessment tools for coronary interventions. This acquisition will strengthen Philips' position in coronary care by integrating SpectraWAVE's HyperVue Imaging System and X1-FFR tool with Philips' Azurion platform.
2025-12
Business Wire
SpectraWAVE Receives 510(k) Clearance for X1u2122-FFR, an AI-enabled, Wire-Free, Drug-Free, Single Angiogram Physiology Solution
SpectraWAVE announced U.S. FDA 510(k) clearance for its X1-FFR, a wire-free, drug-free, single angiogram derived physiology product. This AI-enabled software provides rapid physiology results from a single angiogram and will be available as an add-on to the HyperVue Imaging System.
2025-10
Medical Products Online
FDA OKs SpectraWAVE's AI-Powered Angiogram Physiology Software
SpectraWAVE has obtained U.S. FDA 510(k) clearance for its X1-FFR single angiogram derived physiology software, which uses AI to automate vessel segmentation and frame suggestion for faster FFR results. The X1 software is an add-on to the HyperVue imaging system, offering a combined platform for angiogram-derived physiology and intravascular imaging.
2025-10
Business Wire
SpectraWAVE Announces $50M Series B Financing to Drive Commercial Expansion and Product Additions to the HyperVueu2122 Imaging System
SpectraWAVE, Inc. announced a $50M Series B funding round led by Johnson & Johnson Innovation u2013 JJDC, Inc. This funding will support commercial expansion and product additions to the company's 510k-cleared HyperVueu2122 Imaging System.
2024-09
MedTech Dive
J&J leads $50M financing for imaging company Spectrawave
Spectrawave, a medical imaging company, secured $50 million in Series B funding led by Johnson & Johnson's venture capital arm. The financing will be used to expand commercial efforts and enhance the Hypervue imaging system, which received FDA 510(k) clearance in March 2023.
2024-09
AuntMinnie
SpectraWave raises $50M in funding round
SpectraWave has raised $50 million in a Series B funding round to advance the commercial expansion and product development of its FDA 510(k)-cleared HyperVue Imaging System. The HyperVue system combines DeepOCT and NIRS technology for optimized image quality and procedural efficiency in the cath lab.
2024-09
PMC (PubMed Central)
First-in-Human Experience With a Novel Multimodality DeepOCT-NIRS Intracoronary Imaging System
This article details the first-in-human experience with SpectraWAVE's HyperVue Imaging System, a novel multimodality DeepOCT-NIRS intracoronary imaging system. The study, conducted on 25 patients in Colombia, demonstrated the system's ability to visualize various morphologic features of coronary plaques with high resolution and lipid detection.
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Frequently Asked Questions

SpectraWAVE's flagship product is the HyperVue Imaging System, which integrates DeepOCT (Optical Coherence Tomography) and Near-Infrared Spectroscopy (NIRS) to provide comprehensive images of coronary arteries. This system visualizes both the anatomical structure and chemical composition of coronary plaques, aiding in precise diagnosis and treatment planning.
The HyperVue Imaging System incorporates AI-enabled image analysis for automated measurements and detailed evaluation of plaque characteristics, such as calcium and lipid. This AI integration streamlines workflow, assists in pre-PCI planning and post-PCI optimization, and supports rapid, informed clinical decisions.
Yes, SpectraWAVE offers the X1-FFR software, an AI-enabled add-on to the HyperVue system, which provides wire-free and drug-free Fractional Flow Reserve (FFR) results from a single angiogram. This eliminates the need for invasive pressure wires and associated delays, simplifying the workflow and potentially improving patient safety.
SpectraWAVE's HyperVue Imaging System received FDA 510(k) clearance in 2023, and its X1-FFR software also obtained FDA 510(k) clearance in October 2025. These clearances affirm the devices meet the necessary safety and effectiveness standards for use in coronary artery imaging and physiological assessment.
Royal Philips has entered into an agreement to acquire SpectraWAVE, with the announcement made in December 2025. This acquisition is expected to integrate SpectraWAVE's advanced intravascular imaging and physiological assessment technologies into Philips' image-guided therapy portfolio, enhancing their offerings in cardiovascular care.
SpectraWAVE's HyperVue system provides detailed structural and compositional images of coronary plaques using DeepOCT and NIRS, which is crucial for assessing CAD. Combined with the X1-FFR for physiological assessment, it offers comprehensive insights to guide stent placement and optimize percutaneous coronary interventions (PCI) for better patient outcomes.
While specific details on pricing and support are not publicly disclosed, SpectraWAVE's commitment to improving PCI outcomes suggests comprehensive product demonstrations and sales inquiries are available. Following the acquisition by Philips, support and training are likely to be integrated into Philips' global service and support infrastructure.

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