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APPENDIX B – FY 2004 OSEL Presentations

October 1, 2003 – December 31, 2004

Badano A . Perspectives on current medical display research. Annual Meeting of the American Association of Physicists in Medicine, Pittsburg , PA , 2004, and the High Information Content Display Systems Conference, Arlington , VA , 2004.

Badano A . Light transport in x-ray imaging detectors using DETECT-II, University of Michigan , 2004.

Bassen HI , Casamento JP. High resolution computations and measurements of potential EMI with models of medical implants and radiating sources. IEEE EMC Symposium 2004, IEEE Electromagnetic Compatibility (EMC) Society, 2004 Santa Clara, CA, August 9-13.

Beer JZ , Yamaguchi Y, Zmudzka BZ, Miller SA, Hearing VJ. Early post-UV-exposure dynamics of DNA damage in human skin. FDA/NCI Photobiology Symposium, Rockville , MD , March 9, 2004 .

Beer JZ . Overview of ongoing human studies at the FDA Photosciences Facility. FDA Science Forum, Washington , DC , May 18-19, 2004 .

Cyr WH , Desta AB. Radiofrequency and cell phone research. Bioelectromagnetics Society , Washington , DC , June 24, 2004 .

Cyr WH , Desta AB. Update on the cell phone CRADA. 2004 Joint Workshop on Mobile Telephony and Health. FCC Headquarters, Washington , DC , June 28, 2004 .

Cyr WH , Miller SA. Update on FDA regulation of the indoor tanning industry. Conference on sunlight, tanning booths and vitamin D. Sponsored by the American Academy of Dermatology, Washington , DC , August 2004.

Desta AB , WH Cyr. Update on studies at the national toxicology program. 2004 Joint Workshop on Mobile Telephony and Health. FCC Headquarters, Washington DC , June 28, 2004 .

Dornish M, Kaplan DS. Hyaluronan in tissue engineered medical products: The ASTM guide for the characterization and testing of hyaluronan, Hyaluronan 2003 Meeting, Cleveland , OH , October 11-16, 2003 .

Elespuru RK . FDA perspective and updates on molecular diagnostics and personalized medicine. Molecular Diagnostics and Personalized Medicine, International Business Communications (IBC), Princeton NJ , June 2-4, 2004 .

Fitzgerald B . Cybersecurity in healthcare networks. The Information Security Officers annual meeting of the Veterans Administration, Atlanta , GA , June 23, 2004 .

Fitzgerald B . Cybersecurity in healthcare networks. The SC62a WG22 JWG4, Budapest , Hungary July 26, 2004 .

Fitzgerald B . Cybersecurity in healthcare networks. The System Administrator Officers Annual Meeting of the Veterans Administration, Austin , TX, August 10, 2004 .

Fitzgerald B . Cybersecurity in healthcare networks. The Biomedical Technicians Annual Meeting of the Veterans Administration, Reno , NV, August 23, 2004 .

Fitzgerald B , Murray J. Cybersecurity in healthcare networks. Joint Armed Forces Working Group on Cybersecurity, Martinsburg , WV , September 20, 2004 .

Fitzgerald B , Jones P. Cybersecurity in healthcare networks. Inova Healthcare Systems, Reston VA , September 21, 2004 .

Fitzgerald B . Device Risk Management and Premarket Submissions, annual convention Biomedical Division ASQ, Santa Anna, CA, October 6, 2004.

Godar DE , Dowdy JC, Sliney DH, Coelho SG, Streicher JJ, Landry RJ, Ley RD, Cyr HW. Outdoor and indoor solar UV radiation: contributions toward skin cancer. American Society for Photobiology, Seattle , WA , July 10-14, 2004 .

Goering PL . Mechanisms of metal toxicity. American Chemical Society Continuing Education Course: Chemical Mechanisms in Toxicology, Philadelphia , PA , November 2003.

Harris GR , Maruvada S, Gammell PM. Two efficient methods for measuring hydrophone frequency response in the 100 kHz to 2 MHz range. International Conference on Advanced Metrology for Ultrasound in Medicine, Teddington, Middlesex , UK , April 2004.

Harris GR . High-intensity focused ultrasound for tissue thermal ablation: Potential applications and critical path opportunity. 2004 FDA Science Forum, Washington , DC , May 2004.

He Z, Grimm S, Wagner RF, Wear KA, Jannicky E, Huston D, Garra BS. Dependence of tissue characterization features on region of interest (ROI) size: studies on phantoms and simulations. IEEE Ultrasonics Symposium, Montreal , Canada , August 2004.

Hilbert S , Yanagida R, Krueger P, Jones AL, Wolfinbarger L, Hopkins R.

A comparison of the explant pathology findings of anionic and non-ionic detergent decellularized heart valve conduits. 8 th Annual Hilton Head Workshop, Cardiovascular Tissue Engineering: From Basic Biology to Cell-Based Therapies, Hilton Head Island , SC , March 6-10, 2004 , p 47.

Hutter JC , Luu HMD, Kim CS. Dynamics of Bisphenol A dosimetry in the neuroendocrine organs of rats. International Conference on Health Sciences Simulation, San Diego , CA , January 18-22, 2004 .

Hutter JC , Richardson DC, McDermott MK, Chen ET, Crowe J, Platek F, Witkowski M, Poindexter B, Vostal J. Materials testing of recalled particle contaminated blood bags. 10 th Annual FDA Science Forum, Washington , DC , May 18-19, 2004 .

Hutter JC , Luu MD, Kim CS. Dynamics of Bisphenol A distribution in the neuroendocrine tissues. 10 th Annual FDA Science Forum, Washington , DC , May 18-19, 2004 .

Ilev I . Wave-front ophthalmic sensors for improving vision. LABQUEST FDA/CDRH-USAF Meeting, White Oak, Silver Spring , MD , July 16, 2004 .

Ilev I . Modern optical biometrology: The science of measurement and data validation, ECI-NAALT 2004 Meeting on Light Activated Tissue Regeneration and Therapy, Kona, HI, August 25, 2004.

Jones PL . Medical device HCSS research projects and the FDA. HCSS Research Agenda Minutes, National Coordination Office for Information Technology Research and Development, Washington , DC , December 2003.

Jones PL . Risk management in the design of medical device software systems. International Quality & Productivity Center (IQPC), Washington , DC , March 15, 2004 .

Jones PL . Regulatory interests in certifying medical device software systems. Workshop on building certifiably dependable systems, The National Academies, Washington, DC, April 19-21, 2004.

Jones PL . RTP guidance document announcement - safety cases & essential performance, NEMA workshop, Pittsburgh , PA , July 26, 2004 .

Kim CS, Luu HM, Johnson W, Hutter JC, Ross IA , Sapienza PP. Biodistribution of Bisphenol A in the neuroendocrine organs of female rats. Society of Toxicology, 43 rd Annual Meeting, Baltimore , MD , March 21-25, 2004 .

Krauthamer V . Safety of electrical stimulation in excitable tissues. George Washington University , Department of Biology Seminar, Washington , DC , January 31, 2004 .

Krauthamer V . Non-synaptic modulation in the receptive field size of a sensory neuron. Sarvey Symposium on Synaptic Plasticity, Bethesda , MD , April 2-3, 2004 .

Kuster N, Kainz W. Advances in numerical dosimetry for magnetic reso-nance imaging. ICNIRP-NIR (International Commission on Non-Ionizing Radia-tion Protection - Non-Ionizing Radiation) Workshop & Symposium, Seville , Spain , May 20-22 2004 .

McGuiggan PM, Deng Y, Simon Jr. CG, Wiederhorn SM, Lawn BR, Vegella T, Kaplan DS. Dynamical adhesion force of PSA film and cells. Materials Research Society (MRS) Fall Meetings, Boston , MA , December 1-5, 2003 .

Midgette W . Device risk management: The FDA/regulatory perspective, AAMI 3-day course. Risk Management for Medical Device Manufacturers, Washington , DC , November 12-14, 2003 .

Midgette W . Device risk management and premarket submissions, ISO TC 210/IEC SC 62A JWG1, 3 rd Round Table Forum: ISO 14971- Risk Management for Medical Devices, Sanibel Island , FL , December 2, 2003 .

Midgette W . FDA device regulation and medical device risk management, ADVAMED 2-day course, risk management: ISO 14971: How Medical Device Firms Can Utilize This Standard for the Product Life Cycle, Fort Lauderdale , FL , January 23-24, 2004 .

MidgetteW . Device risk management: The FDA/regulatory perspective, AAMI 3-day course. Risk Management for Medical Device Manufacturers, Phoenix , AZ , February 22-24, 2004 .

Midgette W . Device risk management: The FDA/regulatory perspective, AAMI 3-day course. Risk Management for Medical Device Manufacturers, Dallas , TX , April 17-19, 2004 .

Midgette W . Medical device risk management. 31 st Annual Meeting of the Association of Medical Diagnostic Manufacturers (AMDM), Washington , DC , April 20-21, 2004 .

Midgette W . Device risk management: The FDA/regulatory perspective, AAMI 3-day course. Risk Management for Medical Device Manufacturers, Washington , DC , September 13-15, 2004 .

Myers KJ . Recent developments in medical imaging. GSF-- German National Research Center for Environment and Health, Munich , Germany , October 2004.

Myers KJ . Image perception and its impact on image quality. NCI Young Investigator's Workshop, Rockville , MD , September 2004.

Myers KJ . State of the art in task-based assessment of image quality. Keynote presentation, SPIE Conference on Medical Imaging Physics, San Diego , CA , February 2004.

Pastel MS . FDA/CDRH perspective on regulatory requirements for array bioinformatics. American Association for Clinical Chemistry Lab 2007: Your Eye to the Future, Chicago , IL , October 21-22, 2004 .

Petrick N , Wagner RF. Training and testing CAD algorithms: observer performance studies. NIH Research Festival (Invited Talk), Bethesda , MD , 2004.

Pfefer TJ , Agrawal A, Drezek RA. Computational analysis of fluorescence spectroscopy devices with angled delivery and collection. FDA Science Forum, Washington , DC , May 2004. (conference presentation)

Pritchard WF , Karanian JW. Regulation of medical devices: FDA perspective for university researchers. Institute for Medicine & Engineering, University of Pennsylvania , Philadelphia , PA , December 2003.

Renukananda R, Krauthamer V. Effect of defibrillator-drug interactions on cytosolic calcium in cultured cardiac myocytes. FDA Science Forum, Washington , DC , May 18-19, 2004 .

Ross IA, Sapienza PP, Johnson WW, Luu HM, Hutter JC, Kim CS. Partitioning of Bisphenol a in rat tissue for a physiologically based pharmacokinetic model. Society of Toxicology, 43 rd Annual Meeting, Baltimore , MD , March 21-25, 2004 .

Sergeev N . Microarray detection and typing. Food Microbiology Research Conference XIX, Rosemont , IL , November 9-12, 2003 .

Sergeev N . DNA-microarray-based detection of microbial pathogens. Advanced Topics in Mechanical Engineering: Sensors and MEMS Packaging, University of Maryland , College Park , MD , April 28, 2004 .

Taylor AR . Cybersecurity in healthcare networks. The Information Technology Committee of the Greater New York Hospital Association (monthly meeting), New York , NY , May 12, 2004 .

Taylor AR . Quality by design: whole product life cycle. 2004 FDA Science Forum, Washington , DC , May 18-19, 2004 .

Taylor AR , Dolan A. Risk management for medical devices. American Society of Quality 58 th Annual Quality Congress, Toronto , Ontario , Canada , May 23-26, 2004 .

Tomazic-Jezic VJ , et al. Performance of methods for the measurement of natural rubber latex (NRL) protein, antigen and allergen. Journal of Allergy Clinical Immunology113:s78, 2004.

Wear KA , Stiles TA, Frank GR, Madsen EL, Cheng F, Chérin E, Feleppa EJ, Foster S, Garra BS, Kim BS, Lee P, Miller HL, O’Brien Jr. WD, Oelze ML, Shung KK, Teo TJ, Wilson TA, Yaun JR. Interlaboratory comparison of ultrasonic backscatter coefficient measurements from 2 to 14 MHz. Annual Conference of American Institute of Ultrasound in Medicine, Phoenix , AZ , June 20-22, J. Ultrasound. Med.,23(6) (suppl.), p. S:75-76, June 2004.

Wear KA . Ultrasonic wave propagation and scattering in cancellous bone. 148 th Meeting of the Acoustical Society of America , San Diego , CA , November 15, 2004 . Journal of the Acoustical Society of America116:2477, 2004. (Invited talk)

Weininger , Shang, Goldman, Kopotic, Pennello. Using the Infrared (IR) plethysmogram to assess the effects of motion on the performance of pulse oximeters. Society for Technology in Anesthesia, New Mexico , January 2004.

Weininger S . Plan for quality, BIOMED Seminar. Drexel University , Philadelphia , PA , February 24, 2004 .

Weininger , Shang, Goldman, Kopotic, Pennello. Using the Infrared (IR) plethysmogram to assess the effects of motion on the performance of pulse oximeters. World Congress on Anesthesia, Paris , France , April 2004.

Weininger S . Plan for quality, BEACON Seminar. Springfield , MA , May 20, 2004 .

Weininger S . Medical systems validation - plan for quality. CIMIT Seminar. Cambridge , MA , May 25, 2004 .

Weininger , Osborn. Basic safety and essential performance in medical electrical equipment. 1st IEEE Product Safety Symposium, Santa Clara , CA , August, 2004.

Woods TO . Standards for compatibility of medical devices in the MR environment. Special Lecture, Transcatheter Cardiovascular Therapeutics 2004 Scientific Symposium on Cardiovascular MRI & CT: State of the Art, Washington , DC , October 1, 2004 .

Woods TO . FDA’s critical path research initiative. National Research Council Roundtable 11 th BEMA (Biomedical Engineering Materials and Applications) Meeting, Chips and Arrays, Washington , DC , April 7, 2004

Yamaguchi Y, Tadokoro T, Zmudzka BZ, Miller SA, Beer JZ, Hearing VJ. Physiological regulation of melanocyte proliferation and differentiation in human skin following ultraviolet radiation. PanAmerican Society for Pigment Cell Research Annual Meeting, Newport Beach , CA , June 24-27, 2004 .