Seeing what the eye cannot.
PerfuVue™ is an investigational active short-wave infrared multispectral imaging platform under development for research applications in hemodynamic assessment. Not cleared or approved by the FDA for any clinical or diagnostic use.
The investigational PerfuVue™ system is designed to use multiple feature-optimized SWIR bands in the 900–1700 nm range. Dual-band differential analysis is intended to generate normalized perfusion signals for research purposes only. The device has not been validated for any clinical use.
SWIR BASELINE
SWIR absorption band is designed to image vascular architecture beneath the dermis. Capability is under investigational evaluation.
PERFUSION HEATMAP
Investigational approach: normalized differential signal intended to represent spatial perfusion intensity. Reactive hyperemia protocol is under study for potential assessment of microvascular reserve.
TEMPORAL SIGNAL
Simulated temporal waveform representing investigational hemodynamic analysis concept. The proposed measure of vascular reactivity is under study for research purposes only.
Closed-loop LED ring emits optimized SWIR wavelengths with diffuse reflectance calibration and relay sequencing.
High-resolution SWIR imaging sensors acquire simultaneous multi-band frames at research-grade spatial resolution.
High-performance embedded GPU compute runs KLSOSP analysis and real-time differential normalization on-device.
Hemodynamic maps and investigational indices render in the PerfuVue™ Nexus research dashboard under 21 CFR Part 11.
The investigational system is designed to integrate multimodal imaging (SWIR + Time-of-Flight depth + RGB + Thermal) on a single compute platform. Three proposed research modes are under development. No claims of performance or clinical utility are made.
Investigational dual-band differential imaging is designed to produce perfusion maps during reactive hyperemia protocol for research purposes. Temporal resolution characteristics are under evaluation. No claims of clinical performance are made.
FRAME RATE
0 fps
RESOLUTION
High-Res
MODALITIES
0
SWIR + ToF + RGB + IR
COMPUTE
GPU
Embedded AI Platform
KLSOSP (Kernel Least-Squares Orthogonal Subspace Projection) is a spectral classification method described in published literature (Sheen et al., 2025). It analyzes multi-wavelength data to separate chromophore signatures. Whether this approach achieves robust classification across skin types in PerfuVue™ is under investigation.
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
The investigational system is designed to incorporate a Time-of-Flight depth sensor for depth data acquisition. The intended fusion of SWIR perfusion maps, thermal imagery, and depth data for three-dimensional wound visualization is a development goal under investigation.
DEPTH SENSOR
ToF 3D Camera
THERMAL
Industrial Thermal
SAFETY MCU
Dual Lockstep MCUs
CALIBRATION
Diffuse Reflectance Target
PerfuVue™ is under active development. Published peer-reviewed data on SWIR multispectral imaging methodologies inform the design approach. No claims of clinical safety or efficacy are made. PerfuVue™ has not been evaluated in clinical trials.
Published literature indicates that SWIR imaging operates in the 900–1700 nm range where melanin absorption is reduced compared to visible wavelengths. Whether this physical property enables more equitable hemodynamic assessment across Fitzpatrick skin types I–VI is a hypothesis under investigation. No conclusions regarding clinical utility have been established.
I
II
III
IV
V
VI
UNDER INVESTIGATION ACROSS SKIN TYPES
Relative performance of spectral classification methods as reported in published peer-reviewed literature (Sheen et al., 2025). Data reflects published research findings — not PerfuVue™ clinical trial data. For informational purposes only.
Three purpose-built research interfaces under development — investigational hemodynamic dashboard, study monitoring, and safety oversight — designed with 21 CFR Part 11 audit trail architecture in mind. Interface mockups shown for illustrative purposes only. Not representative of actual study data.
PERFUSION INDEX
—
Investigational
REACTIVITY INDEX
—
Investigational
STATUS
Planned
DESIGN
Multicenter
Multicenter study monitoring interface with enrollment tracking, site management, and protocol compliance — designed for future investigational use.
SERIOUS AEs
—
Tracking planned
TOTAL AEs
—
Tracking planned
Safety monitoring architecture under development. No active study data displayed.
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
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.
PROVISIONAL FILING SERIES
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.
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
PerfuVue™ is being developed with potential future research applications in populations with elevated diabetes prevalence and disproportionate amputation rates, including the veteran community. No investigational studies have been initiated in these populations.
Published epidemiological data indicate diabetes prevalence exceeds 25% in the veteran population, with lower-extremity amputation rates remaining disproportionately high. Whether earlier hemodynamic assessment could support improved outcomes is a hypothesis under investigation. PerfuVue™ has not been demonstrated to improve clinical outcomes.
EHR DESIGN
HL7/FHIR Compatible
COMPLIANCE
21 CFR Part 11
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
Founded by Garyn Angel, Quant Opt Medical Systems is dedicated to developing investigational imaging technology intended to make subcutaneous hemodynamic information visible and quantifiable for research purposes. The long-term goal is to support research into diabetic neuropathy assessment, cardiovascular risk, and wound care science — especially for underserved populations and veterans. These are aspirational research goals, not established capabilities of the device.
PerfuVue™ is being developed with the intent to pursue FDA De Novo classification. The quality management system is being designed to align with ISO 13485, IEC 62304 software lifecycle, ISO 14971 risk management, and 21 CFR Part 11 electronic records requirements. The hardware architecture incorporates dual safety MCUs in lockstep configuration, designed to align with IEC 60601-1 electrical safety requirements. Compliance with these standards has not yet been formally verified or certified.
Garyn Angel
Founder & CEO
Combining expertise in quantitative optical systems, embedded hardware design, and medical imaging to advance SWIR hemodynamic imaging research toward potential future clinical applications, subject to regulatory clearance.
PerfuVue™ is designed to integrate multimodal imaging sensors, embedded computing, and microcontroller supervision on a single research platform. The system architecture is under active development. Technical details may be available under NDA for qualified research partners.
Interested in PerfuVue™ for your research program or investigational study? Contact us to learn more.