Image quality and system performance are essential for effectiveness of biomedical optical imaging devices (BOIDs). BOIDs emit and/or detect light signals (point signals, images, etc.) over ultraviolet, visible and infrared wavelength ranges for disease diagnosis/surveillance/screening, physiological and anatomical measurements, and cancer imaging. Representative BOIDs include traditional tubular endoscopes, novel capsule endoscopes, promising mobile-phone-based medical devices and infrared imaging cameras. While novel techniques keep emerging, regulatory science needs to keep pace with these innovations to ensure safety and effectiveness. The effectiveness of BOIDs is determined by image quality and system performance. Our research on device evaluation focuses on establishing and updating consensus standard and guidance documents on quantitative, objective test methods to evaluate characteristics of image quality and system performance (e.g., system optical transfer function, resolution, distortion, and noise) as well as best practices for device use. The research helps to elucidate the working mechanisms of new optical imaging technologies, facilitate swift, science-based evaluation and ensure their effectiveness during clinical use.
Computational biophotonics is an efficient approach for understanding device working mechanisms and addressing safety and effectiveness issues relevant to spectroscopy and imaging for disease detection and physiological/anatomical measurements. Our research on computational biophotonics is based primarily on Monte Carlo modeling and covers a wide spectrum of applications including cancer detection, reflectance imaging, fluorescence imaging, optical radiation safety, etc. The research supports FDA needs on safety and effectiveness issues on emerging optical technologies such as narrow band imaging and cancer detection with nanoparticles contrast agents.
Smart-phone-based telemedicine devices
Simulation of light fluence distribution in tissue
Current funding sources
- FDA Medical Countermeasures Initiative (MCMi)
Ebola-related Regulatory Science (ERS)
- FDA Critical Path Initiative
- FDA Office of Women’s Health (OWH)
Quanzeng Wang, Ph.D.
Joshua Pfefer, Ph.D.
Pejhman Ghassemi, Ph.D.
Yedukondala Narendra Dwith Chenna
- College of Optical Sciences, University of Arizona, Tucson
- Florida International University, Miami
- Fischell Department of Bioengineering, University of Maryland, College Park
- Intuitive Surgical, Inc.
- Leiner Optics
- PENTAX MEDICAL
- STERIS Instrument Management Systems, Inc.
- Thermographic cameras
- Black body
- Clinical narrow band imaging device (endoscopic)
- Other clinical imaging device (colposcope, etc.)
- Fiberoptic reflectance and fluorescence spectroscopy systems
- Spectrophotometer with integrating sphere
- Spectrofluorometer with dual monochrometer excitation and emission
Relevant Standards & Guidances
- Reporting of Computational Modeling Studies in Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- ISO 8600-1: Endoscopes — Medical endoscopes and endotherapy devices – Part 1: General requirements
- ISO 8600-3: Optics and optical instruments — Medical endoscopes and endotherapy devices – Part 3: Determination of field of view and direction of view of endoscopes with optics
- ISO 8600-5: Optics and photonics — Medical endoscopes and endotherapy devices – Part 5: Determination of optical resolution of rigid endoscopes with optics
- ISO 8600-6: Optics and photonics — Medical endoscopes and endotherapy devices – Part 6: Vocabulary
- ISO 80601-2-56: Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- IEC 80601-2-59: Medical electrical equipment — Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening
- ISO/TR 13154: Medical electrical equipment — Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
- IEEE Project: P1858 — IEEE Draft Standard for Camera Phone Image Quality (CPIQ)
Standards Committee Participation:
- US TAG to ISO/TC 172 Optics and Photonics, SC 5 Microscopes and Endoscopes, WG 6 (Endoscopes).
- US TAG to ISO/TC 121 Anaesthetic and respiratory equipment, SC 3 Lung ventilators and related equipment, JWG 8 (Clinical thermometer).
- US TAG to IEEE / WG 1858 (Camera phone image quality)
- US TAG to ISO / TC 42 (Photography) / WG 18 (Electronic still picture imaging)
Selected peer-review publications
- Wang et al., Endoscope field of view measurement, Biomedical Optics Express, 2017.
- Wang et al., Development of the local magnification method for quantitative evaluation of endoscope geometric distortion, Journal of biomedical optics, 2016.
- Le et al., Vascular contrast in narrowband and white-light imaging, Applied Optics 2014.
- Gould et al., Optical-thermal light-tissue interactions during photoacoustic breast imaging, Biomedical Optics Express 2014.
- Le et al., Monte Carlo modeling of light-tissue interactions in narrow band imaging, Journal of Biomedical Optics Letters 2013.
- Wang et al., Broadband ultraviolet-visible optical property measurement in layered turbid media,Biomedical Optics Express 2012.
- Pfefer et al.,Monte Carlo modeling of time-resolved fluorescence for depth-selective interrogation of layered tissue, Computer Methods and Programs in Biomedicine, 2011.
- Wang et al., Experimental and theoretical evaluation of a fiber-optic approach for optical property measurement in layered epithelial tissue, Applied Optics 2010.
- Wang et al., Condensed Monte Carlo Modeling of Reflectance From Biological Tissue With a Single Illumination-Detection Fiber, IEEE Journal of Selected Topics in Quantum Electronics, 2010.
- Wang et al., Measurement of internal tissue optical properties at ultraviolet and visible wavelengths: Development and implementation of a fiberoptic-based system, Optics Express 2008.