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  1. CDRH Research Programs

Optical Image Quality and Computational Biophotonics


Quangzeng Wang, Ph.D.


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.

Gastrointestinal Endoscopes

Gastrointestinal endoscopes

Telemedicine Devices

Smart-phone-based telemedicine devices

Light fluence distribution in tissue

Simulation of light fluence distribution in tissue

Current funding sources


FDA Staff:
Quanzeng Wang, Ph.D.
Joshua Pfefer, Ph.D.
Wei-Chung Cheng

Research Fellows:
Pejhman Ghassemi, Ph.D.
Yedukondala Narendra Dwith Chenna
Nitin Suresh

External collaborators

Resource facilities

  • 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

Guidance documents:

Standard douuments:

Standards Committee Participation:


Selected peer-review publications

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