Seeing what the eye cannot.

Investigational SWIR
Hemodynamic Imaging

CAUTION — Investigational device. Limited by Federal (or United States) law to investigational use.

PerfuVue™ is an investigational active short-wave infrared multispectral imaging platform under development for research applications in hemodynamic assessment across all skin tones.

FDA De Novo Pathway — Investigational 21 CFR Part 11 Compliant
900 nmSWIR1700 nm
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Active SWIR Multispectral Imaging

Multiple feature-optimized SWIR bands in the 900–1700 nm range are used in this investigational multispectral imaging system. Dual-band differential analysis generates normalized perfusion signals for research purposes only.

SWIR BASELINE

Structural Baseline

SWIR absorption band captures vascular architecture beneath the dermis for investigational research imaging.

PERFUSION HEATMAP

Hemodynamic Map

Normalized differential signal converted to spatial perfusion intensity. Reactive hyperemia protocol reveals microvascular reserve.

TEMPORAL SIGNAL

Investigational Index

Temporal waveform from investigational hemodynamic analysis. Measure of vascular reactivity under study for research purposes.

How PerfuVue™ Works

1

Illuminate

Closed-loop LED ring emits optimized SWIR wavelengths with diffuse reflectance calibration and relay sequencing.

2

Capture

High-resolution SWIR imaging sensors acquire simultaneous multi-band frames at research-grade spatial resolution.

3

Compute

High-performance embedded GPU compute runs KLSOSP analysis and real-time differential normalization on-device.

4

Visualize

Hemodynamic maps and investigational indices render in the PerfuVue™ Nexus research dashboard under 21 CFR Part 11.

PerfuVue™ Imaging System

Multimodal (SWIR + Time-of-Flight depth + RGB + Thermal) imaging fused on a single compute platform. Three investigational modes deliver hemodynamic intelligence for research purposes.

LIVE PERFUSION FEED — 30 FPS

Real-Time Perfusion Monitoring

Continuous dual-band differential imaging produces live perfusion maps during reactive hyperemia protocol. Sub-second temporal resolution captures the full vascular reactivity curve from occlusion to peak hyperemia.

FRAME RATE

0 fps

RESOLUTION

High-Res

MODALITIES

0

SWIR + ToF + RGB + IR

COMPUTE

GPU

Embedded AI Platform

Band 1Band 2Band 3 Band 4Band 5Band 6

Multi-Band Deep Spectral Analysis

KLSOSP (Kernel Least-Squares Orthogonal Subspace Projection) expert model analyzes multi-wavelength data to separate chromophore signatures. The kernel function trick projects spectral features into higher-dimensional space for robust classification across skin types.

FOSIL-WSM selected optimized wavelengths via a two-stage voting system across five ranking-band selection methods — as described in published peer-reviewed literature.

SWIR PERFUSION + ToF DEPTH FUSION

3D Volumetric Mapping

Time-of-Flight depth sensor provides millimeter-accurate depth data. Fused with SWIR perfusion maps and thermal imagery, researchers can visualize wound topology with hemodynamic state overlaid in three dimensions.

DEPTH SENSOR

ToF 3D Camera

THERMAL

Industrial Thermal

SAFETY MCU

Dual Lockstep MCUs

CALIBRATION

Diffuse Reflectance Target

Ongoing Research

PerfuVue™ is under active investigation. Published peer-reviewed data on SWIR multispectral imaging methodologies are being reviewed as part of ongoing development activities. No claims of clinical efficacy are made at this time.

Skin Tone Equity — Research Rationale

SWIR imaging operates in the 900–1700 nm range where melanin absorption is negligible. This physical property suggests the potential for more equitable hemodynamic assessment across Fitzpatrick skin types I–VI compared to visible-light systems. This hypothesis is under investigation.

I

II

III

IV

V

VI

UNDER INVESTIGATION ACROSS SKIN TYPES

Research — Classification Methods

Relative performance of spectral classification methods studied in published literature. For research purposes only.

PerfuVue™ Dashboard Suite

Three purpose-built research interfaces — investigational hemodynamic dashboard, study monitoring, and safety oversight — designed with 21 CFR Part 11 audit trail architecture. For investigational use only.

Hemodynamic Dashboard
LIVE

PERFUSION INDEX

Investigational

REACTIVITY INDEX

Investigational

Research mode
Study Monitor INVESTIGATIONAL

STATUS

Planned

DESIGN

Multicenter

Multicenter study monitoring interface with enrollment tracking, site management, and protocol compliance — designed for future investigational use.

DSMB Dashboard OVERSIGHT

SERIOUS AEs

0

TOTAL AEs

3

NO STOPPING CRITERIA MET

Data freeze: Scheduled | Periodic review

Research & Patents

Core innovations protected by a growing patent portfolio covering real-time hemodynamic imaging, closed-loop multimodal spectral systems, and SWIR-specific LED illumination architectures.

NON-PROVISIONAL UTILITY FILING

Real-Time Hemodynamic Imaging System & Method

Non-provisional utility patent covering the complete PerfuVue™ architecture: active SWIR LED multispectral illumination with closed-loop intensity control, simultaneous multi-band capture, differential normalization, investigational scoring algorithms, and 3D perfusion topology fusion.

Dual-Band SWIRDifferential Normalization Hemodynamic IndicesClosed-Loop Control

PROVISIONAL FILING SERIES

Provisional Patent Portfolio

Multiple provisional filings protecting innovations in SWIR LED wavelength selection methodology, multimodal sensor fusion (SWIR + ToF + Thermal + RGB), safety-critical dual-MCU lockstep architecture, and closed-loop calibration for research repeatability.

FOSIL-WSM MethodMultimodal Fusion Safety ArchitectureLED Illumination

Published Research

Sheen, Y.J. et al. (2025)

"Advanced diabetic peripheral neuropathy detection: Validation of expert models and development of active short-wave infrared multispectral imaging techniques." Expert Systems With Applications, 269, 126462.

DOI: 10.1016/j.eswa.2025.126462 | Elsevier | CC BY-NC-ND 4.0

Research in High-Risk Populations

PerfuVue™ is being evaluated in research settings for potential applications in populations with elevated diabetes prevalence and disproportionate amputation rates, including the veteran community.

Unmet Clinical Need

Diabetes prevalence exceeds 25% in the veteran population, with lower-extremity amputation rates remaining disproportionately high. Earlier hemodynamic assessment may support improved outcomes — this hypothesis is under investigation.

EHR DESIGN

HL7/FHIR Compatible

COMPLIANCE

21 CFR Part 11

Research Focus Areas

Hemodynamic imaging in diabetic peripheral neuropathy

Cardiovascular risk stratification via perfusion analysis

Equitable assessment across diverse skin tones

Wound care hemodynamic monitoring

INVESTIGATIONAL — NOT CLEARED FOR CLINICAL USE

Quant Opt Medical Systems

Our Mission

Founded by Garyn Angel, Quant Opt Medical Systems is dedicated to making subcutaneous hemodynamic information visible, quantifiable, and actionable. By bridging advanced photonics with research workflow, PerfuVue™ aims to enable earlier assessment of diabetic neuropathy, support cardiovascular risk research, and advance wound care science — especially for underserved populations and veterans.

Regulatory & Quality

PerfuVue™ is being developed under FDA De Novo classification pathway with full ISO 13485 quality management, IEC 62304 software lifecycle, ISO 14971 risk management, and 21 CFR Part 11 electronic records compliance. Dual safety MCUs in lockstep configuration provide IEC 60601-1 electrical safety with independent hardware watchdog supervision.

Founder

GA

Garyn Angel

Founder & CEO

Combining expertise in quantitative optical systems, embedded hardware design, and medical imaging to bring SWIR hemodynamic imaging from laboratory research to the point of care.

System Architecture

PerfuVue™ integrates multimodal imaging sensors, high-performance embedded computing, and safety-critical microcontroller supervision on a single research platform. Technical specifications are available under NDA for qualified research partners.

SWIR ImagingDepth MappingThermal RGBSafety MCUCalibration

Get in Touch

Interested in PerfuVue™ for your research program or investigational study? Contact us to learn more.