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U.S. Department of Health and Human Services

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Laboratory of Optical Therapeutics and Medical Nanophotonics

Laboratory leader: Ilko Ilev, PhD, 301.796.2489 ilko.ilev@fda.hhs.gov

OTMN Lab Scope: The Biophotonics and Nanobiophotonics field includes many emerging biomedical technologies that are increasingly being applied in various vast areas of life sciences and biomedicine ranging from minimally invasive optical diagnostics and therapeutics to development of novel nanobiotechnologies and nanobiomaterials. Minimally invasive, cost-effective and rapid biophotonics techniques and devices have been recently developed as potential alternatives to conventional medical methods for diagnostics, monitoring and treatment of a variety of diseases, drug discovery, proteomics, and environmental detection of biological agents. These techniques offer a noncontact, effective, fast, and painless way for sensing and monitoring various biomedical quantities. Medical devices utilizing minimally invasive biophotonics technology are rapidly finding their way into the mainstream for early disease diagnosis and improved patient acceptance and comfort. Optical therapeutics approaches are being proposed that use ultrashort laser radiation pulses, precise delivery fiber optics and near/mid-infrared biosensing and monitoring. Currently, CDRH is faced with the need to prepare to evaluate devices being developed to optically diagnose and threat various diseases including pre-cancer and cancer conditions.

The Optical Therapeutics and Medical Nanophotonics Laboratory of CDRH/OSEL’s Division of Physics is responsible for providing and maintaining state-of-the-art knowledge and expertise in the areas of biophotonics, nanobiophotonics, biomedical optics and medical lasers. The OTMN Lab assists the Center and Agency in evaluating the safety and effectiveness of new optical therapeutics techniques and devices as well as in developing test protocols, guidances and standard test methods for evaluating critical fundamental parameters and features of recently developed optical therapeutics and nanobiophotonics techniques and devices. The OTMN Lab research and regulatory related projects are focused in the following key areas:

  1. Evaluating the safety and effectiveness of new optical therapeutics technologies and devices concerning critical optical parameters and safety issues related to various medical therapeutic lasers, fiber-optic technologies and new therapeutic monitoring and biosensing systems
  2. Developing standard test methods and test protocols for laboratory evaluation of fundamental optical radiation characteristics including spectral (from the ultraviolet to mid-infrared), timescale (from millisecond to femtosecond) and spatial parameters of key coherent (lasers) and non-coherent light sources, and fiber-optic components used in recently developed optical therapeutics devices
  3. Studying working light-tissue interaction mechanisms for optimizing effectiveness and safety of new optical therapeutics devices, which includes light-tissue interaction mechanisms at cellular and intracellular levels using state-of-the-art nanobiosensing, nanoimaging and therapeutics techniques.