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APPENDIX B – FY 2008 OSEL Presentations

January 1, 2008 – December 31, 2008

Badano A, Sempau J. SPIE Short Course: Monte Carlo simulation of Medical Imaging Systems.  San Diego, CA, February 2008. 

Bassen H, Mendoza G. Spatial mapping of E fields induced at tips of pacemaker leads by MR gradient fields.  Presented at the 2008 ISMRM MR Safety Meeting, July 2008. (Published in conference proceedings.)

Brenner M, Coelho SG, Beer JZ, Miller SA, Wolber R, Smuda C, Hearing VJ. Persistent molecular changes after repetitive in situ UV exposures of human skin. 35th Meeting of the Arbeitsgemeinschaft Dermatologische Forschung (ADF, German Society for Dermatological Research), Erlangen, Germany, February 2 -March 1, 2008.

Brenner M, Coelho SG, Beer JZ, Miller SA, Wolber R, Smuda, Hearing VJ. Persistent molecular changes after repetitive in situ UV exposures of human skin. International Meeting on Investigative Dermatology, Kyoto, Japan, May 14-17, 2008.

Brown D.  Invited presentation on qualification of imaging as a surrogate biomarker Cardiovascular Biomarker and Surrogate Endpoints Symposium, Washington, DC, September 2008.

Brown D.  Invited panelist:  Imaging in Clinical Trials, DIA, Washington, DC, October 2008.

Brown D. Invited presentation on imaging research and regulatory programs at FDA Beckman Institute, University of Illinois, November 2008.

Cabot E, Capstick M, Neufeld E, Kühn S, Kainz W, Oberle M, Christ A, Kuster N. Numerical and experimental evaluation of RF-Induced heating of a generic medical implant during MRI exams. BEMS 2007, 30th Annual Meeting, June 8-12, 2008. 

Chen W, Wagner RF, Yousef WA.  Assessment of predictive models in the multiple-biomarker problem: figures of merit and uncertainty estimation Presentation at 8th MicroArray Quality Control Phase II (MAQC-II) project meeting, Rockville, MD, March 26, 2008. 

Chiesa OA, Heller D, Karanian JW,  Pritchard WF, Lopez M, Von Bredow J. Videoendoscopic serial sampling in swine to monitor the pharmacokinetic elimination of Penicillin from tissues and fluids. Veterinary Endoscopy Society, Keystone, CO, March 2008.

Civelek M, Grant GR, Irolla CR, Riley R, Stoeckert CJ, Karanian JW, Chiesa OA, Pritchard WF, Davies PF.  ABCA1 is upregulated in athero-protected regions of arteries in response to brief hypercholesterolemia treatment in vivo. Experimental Biology 2008, San Diego, CA, 2008.

Cleary K, Pfefer J.  Minimally invasive contact tissue characterization: Sensors, optical imaging, and image guidance. Bioengineering and Imaging Research Opportunities, Workshop 5, 2008. 

Coelho SG, Zhao Y-C, Bushar H, Miller SA, Zmudzka BZ, Hearing VJ, Beer JZ. Insights into UV-induced long-lasting pigmentation in human skin. 20th International Pigment Cell Conference, Sapporo, Japan, May 7-12, 2008.

 Cohen E. Effects of high-level pulse train stimulation on retinal function.  The Eye and the Chip, World Congr Artifical Vision, June 2008.

Cohen E. A novel method for examining the effects of electrical stimulation on the light response of retinal ganglion cells.  ARVO 2008, June 2008.

Dair BJ. Effect of medical device substrate material on nanoparticulate silver efficacy. 2008 NSTI Nanotechnology Conference, Boston, MA, June 2008. 

Dasgupta S, Hariharan P, Myers M R, Banerjee R K. Effect of rate of blood flow through large blood vessels on HIFU temperature rise. 2008 ASME Summer Bioengineering Conference, Marco Island, FL, June 2008.  (Conference paper published in conference proceedings.)

Farhat Y, Mazhar A, Huang E, Pfefer J, Choi B. Monte-Carlo-based study of depth-resolved laser speckle imaging with spatially modulated light.  ASLMS Annual Conference, April 5, 2008. 

Gallas B. Session at ENAR (2008). Nonparametric methods for analyzing MRMC ROC data (invited presentation), Arlington, VA, 2008.

Gallas B.  Recent developments in ROC analysis.  Cardiovascular Biomarker and Surrogate Endpoints Symposium, Washington, DC, September 2008.   

Gallas B.  Regultory considerations in central image analysis: optimizing practices and procedures.  The 2008 Critical Markers of Disease Conference (2008). Technical workshop at the SPIE-MI Conference, San Diego, CA, 2008.

Guerraty MA, Grant G, Karanian JW, Chiesa OA, Pritchard WF, Davies PF. Brief hypercholesterolemia induces athero-protective pathways on the patho-susceptible aortic side endothelium of swine aortic valves. Experimental Biology 2008, San Diego, CA, 2008. 

Hariharan P, Myers MR, Robinson RA, Maruvada S, Sliwa J, Banarjee R K. A streaming-based technique for free-field characterization of HIFU transducers.  8th International Symposium on Therapeutic Ultrasound, Minneapolis, MN, September 2008. 

Hariharan P, Myers MR. Use of mathematical modeling to characterize high intensity focused ultrasound (HIFU) Devices.  Computation Modeling Group meeting, FDA, December 11, 2008.

Hsu E. Cancer prevention research in the regulatory framework of the FDA.  Presentation for the Cancer Prevention Fellowship Program, Office of Preventive Oncology, National Cancer Institute, Bethesda, MD, April 9, 2008.

Hsu ER, Gallas BD, Chen WJ.  Accounting for variability in cancer imaging technologies: illustration using colposcopy and cervical cancer diagnosis (poster). 7th Annual Cancer Prevention Fellows’ Scientific Symposium, National Cancer Institute, National Institutes of Health, Bethesda, MD, September 24, 2008.

Hsu ER, Gallas BD, Chen WJ. Accounting for variability in cancer imaging technologies: illustration using colposcopy and cervical cancer diagnosis (poster).  AACR Centennial Conference Translational Cancer Medicine 2008: Bridging the Lab and the Clinic in Cancer Medicine.  Jerusalem, Israel, November 3-6, 2008.

Hsu ER, Gallas BD, Chen WJ, Pennello G. Assessment of models for combining colposcopy features for cervical cancer diagnosis (poster).  Seventh Annual AACR International Conference on Frontiers in Cancer Prevention Research. Washington, DC, November 16-19, 2008.

Ilev I, Faaland R, Kim D, James R, Calogero D. Preclinical IOL optical testing: Optical requirements and advanced test methods: CDRH Ophthalmic and ENT Network Education Series, Rockville, MD, February 28, 2008.

Jetley R. Research issues in medical device software. Presented at Fraunhofer USA, Center for Experimental Software Engineering, College Park, MD, July 21, 2008.

Kainz W.  Safety considerations for radio frequency-induced heating of implants. ISMRM Safety Workshop, Lisbon, Portugal, July 13-14, 2008.

Kainz W. MR critical implants, MR critical medical devices and ASTM MR safety standards. The International Society for Magnetic Resonance in Medicine, Seventeenth Scientific Meeting and Exhibition, Honolulu, Hawai'i, USA, April 18-24, 2009.

Kainz W. Fiedler F, Bobgan J, Schaefers G, Luechinger R, Szeverenyi N, Wedan S. Variation of whole body averaged phantom specific absorption rate (SAR). ASIA-Pacific EMC Week, Topical Meeting on Biomedical Electromagnetics, Singapore, May 19 - 23, 2008.

Karanian JW. The science of evaluating combination devices. FDA Science Writers Symposia, November, 10, 2008.

Katz E, Kim DH, Ilev I, Krauthamer V. Optical stimulation of rat sciatic nerves:  Effect of repetition rate on the amplitude of light–evoked compound action potentials. USUHS Neurocience Forum, December 3, 2008.

Katz E, Kim DH, Ilev I, Krauthamer V. Effects of optical irradiation parameters on safe peripheral nerve stimulation with infrared light. USUHS Neuroscience Open House, Bethesda, MD, December 3, 2008.

Keshvari J, Sotoudeh O, Siegbahn M, Bit-Babik G, Kainz W. CAD-phone SAR computational inter-laboratory study IEEE TC34, SC2-WG2 1528.3. 2nd International Conference on Bioinformatics and Biomedical Engineering, Shanghai, China, May 16-18, 2008.

Kim C-S. Modeling structure development and release behavior of drug embedded in block copolymer matrices. 235th ACS National Meeting, New Orleans, LA, April 6-10, 2008. 

Kinnard L. Math and science careers. Key Middle School, Silver Spring, MD, May 2008.

Kinnard L. Volume bias and variability: A thoracic phantom study. National Institutes of Standards and Technology, Gaithersburg, MD, September 2008. 

Krauthamer V. The role of basic science in the design of clinical trials for CNS devices. Presentation at the 4th Annual Conference, International Society for CNS Clinical Trials and Methodology, Washington, DC, February 25 -27, 2008.

Liu Y, Maruvada S, King RL, Herman BA, Wear KA. Temperature-dependent physical properties of a HIFU blood mimicking fluid.  8th International Symposium on Therapeutic Ultrasound, Minneapolis, MN, September 2008. 

Maruvada S, Liu Y,  Herman BA, Pritchard WF,  Harris GR. Temperature measurements and determination of cavitation thresholds during high intensity focused ultrasound (HIFU) exposure in ex-vivo porcine muscle. 155th Meeting of the Acoustical Society of America, Paris, France, June 2008.

Maruvada S, Liu Y, Herman BA, Harris GR. Temperature measurements in tissue-mimicking material during HIFU exposure. 8th International Symposium on Therapeutic Ultrasound, Minneapolis, MN, September 2008. 

Maruvada S, Liu Y, Herman BA, Pritchard WF, Harris G R. Temperature measurements and determination of cavitation thresholds during high intensity focused ultrasound (HIFU) exposures in ex-vivo porcine muscle. 156th Meeting of the Acoustical Society of America, Paris, France, June 29- July 4, 2008. 

Maruvada S, Liu Y,  Herman BA, Harris GR. Temperature measurements in tissue-mimicking material during hifu exposure.  8th International Symposium on Therapeutic Ultrasound, Minneapolis, MN, September 2008. 

Maruvada S. A Radiation force technique for acoustic power calibration of high intensity focused ultrasound transducers. (Invited talk) 157th Meeting of the Acoustical Society of America, Miami, Fl, November 10-14, 2008. 

Myers KM, Bilek A. Quantitative imaging methods: regulatory hurdles and the CDRH perspective. RSNA Strategic Planning Workshop toward Quantitative Imaging, Oak Brook, IL, July 10-11, 2008.  (Invited)

Myers KJ. ROC analysis, image assessment methodologies, and biomarker validation, NIH NIBIB Advisory Council, Bethesda, MD, May 16, 2008. (Invited)

Myers KJ. Quantitative assessment of tumor size measures with thoracic CT imaging.  RSNA Imaging Biomarkers Roundtable, Oak Brook, IL, April 3-4, 2008. (Invited)

Myers MR, Hariharan P, Maruvada S, Sliwa J, Banerjee RK. A streaming-based technique for free-field characterization of HIFU transducers.  8th International Society of Therapeutic Ultrasound (ISTU) Conference, Minneapolis, MN, September 2008. 

Nandkumar S, Woods T, Kainz W. Issues in testing cochlear implants for MRI compatibility. 10th International Conference on Cochlear Implants and Other Implantable Auditory Technologies, San Diego, CA, April 10 – 12, 2008.

O’Hara MD, Granek JL, Margo J, Ambrose A, Gomantam S, Desta A. The radiation response and hyperthermic radiosensitization of human melanoma cells grown at pH 6.7.     

Patwardhan DV. Microstructure to drug release in drug eluting stents. Annual Sotax User Group, June 2008 (invited).

Patwardhan DV. Drug microstructure to drug release.  235th ACS National Meeting, New Orleans, LA, April 6-10, 2008. 

Petrick N, Kinnard LM, Gavrielides MA, Zeng RP, Myers KJ. Assessment of nodule volume error: initial results from an anthropomorphic phantom experiment. 18th International Conference on Screening for Lung Cancer and the Lung Cancer Workshop V (Invited Talk), Prevention Cancer Foundation, Oakbrook, IL, April 2008.

Petrick N, Kinnard LM, Linguraru M, Gavrielides MA, Peregoy J, Myers KJ, Pritchard W, Karanian J. Influence of CT exposure on the estimation of lung nodule volume: An anthropomorphic phantom experiment.. Radiology Society of North America, Chicago, IL, November 30-December 5, 2008.

Pollack S.  Polymer reliability and FDA perspective. University of California, Santa Barbara, February 2008. 

Pollack S.  Medical devices regulation for University of Delaware entrepreneur class. University of Delaware, March 2008. 

Pollack S.  Polymers in medical devices.  University of Maryland, College Park, MD, November 2008.  

Pollack S.  CSI meets the FDA: heparin contamination. Howard University, Washington, DC, November 2008.

Pritchard WF, Karanian JW. Regulation of medical devices: Bench to bedside to market. Institute for Medicine and Engineering Mini-Symposium co-sponsored by the Dept of Bioengineering, University of Pennsylvania, Philadelphia, PA, January 22, 2008. 

Pritchard WF, Karanian JW, Constante E, Chiesa O, Peregoy JA, Esparza J, Murray T. Evaluation of vascular motion of peripheral arteries in swine: toward predictive modeling of clinical failure modes. Radiological Society of North America, Chicago, IL, November 30-December 5, 2008. 

Qiang R, Jackson D, Wilton D, Chen J, Kainz W. Time-domain modeling techniques for periodic structures. International Microwave Symposium, IEEE Microwave Theory and Techniques Society (MTT-S), Atlanta, GA, June 15 -20, 2008. 

Saylor DM. Microstructure-based modeling of controlled drug release coatings. FDA/NSF/NIH Workshop on Computer Methods in Cardiovascular Device Design & Evaluation, March 18, 2008 (invited).

Saylor DM. Microstructure-based modeling of controlled drug release coatings. George Mason University, Virginia, April 18, 2008 (invited).

Saylor DM. Microstructure-based modeling of controlled drug release coatings. Materials Science & Technology 2008 Conference and Exhibit, October 6, 2008. 

Shah S, Kapoor A, Ding J, Guion P, Stoianovici D, Petrisor D, Karanian JW, Pritchard WF, Wood BJ, Cleary K. Robotically assisted needle driver: evaluation of safety release, force profiles, and needle spin in a swine model. 22nd International Congress and Exhibition, CARS 2008: Computer Assisted Radiology and Surgery, Barcelona, Spain, 2008.

Sharma K, Dreher M, Orandi BJ, Tang Y, Lewis A, Karanian J, Chiesa OA, Pritchard WF, Wood BJ. Development of image-able bead technology to optimize delivery of transarterial catheter directed therapies. Radiological Society of North America, Chicago, IL, November 30- December 5, 2008.

Silberberg J. FDA/CDRH recognition of IEC 60601-1-2. Presented at IEEE EMC Society Twin Cities Chapter Meeting, Minneapolis, MN, January 22, 2008. 

Silberberg J. An FDA perspective on EMC of medical electrical equipment and medical electrical systems. Invited distribution to the Japan Federation of Medical Devices Associations (JFMDA), June 2008. 

Silberberg J. EMI problem reports. Invited distribution to the Japan Federation of Medical Devices Associations (JFMDA), June 2008. 

Silberberg J. EMC Standards for medical devices. Presented at AAMI CRMD Committee Meeting, Washington, DC, July 24, 2008. 

Silberberg J. ANSI/AAMI/IEC 60601-1-2, FDA, and You. AAMI Webinar, December 12, 2008. 

Spees W. Lightweight Java state machine: Returning to a simple idea. Presented at CAPSCI 2008, Washington, DC, March 30, 2008. 

Stewart SFC, Malinauskas RA, Berman MR. Validation of computational fluid dynamic techniques used to evaluate medical devices: An FDA Critical Path Initiative, FDA/Drug Information Association Workshop (FDA Critical Path Initiative on the Move), Bethesda, MD, September 15-16, 2008.

Walsh DL, Schwerin MR, Das SS, Zheng Z. Lubricant/condom compatibility: Protocol development and preliminary results. ASTM D11.40.01 Condom Task Group Meeting, Miami Beach, FL, December 8, 2008.

Walsh DL, Schwerin MR, Brodrick TJ. Effect of IPA on latex condoms, preliminary analysis.  ASTM D11.40.01 Condom TG meeting, Denver, CO, June 23, 2008. 

Wear KA, Harris GR. Frequency dependence of backscatter from thin, oblique, finite-length cylinders measured with a focused transducer – with applications in cancellous bone,” 2008 IEEE International Ultrasonics Symposium,  Beijing, China, November 2008. 

Witters D,  Seidman S, Kainz W, Gonzalo Mendoza, Ken Umberger. Wireless technology in healthcare: mobility vs. safe and reliable deployment. Demonstration and abstract, 2008 FDA Science Forum, Silver Spring, MD, November 13, 2008.