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APPENDIX B – FY 2009 OSEL Presentations

January 1, 2009 – December 31, 2009

Abi-Jaoudeh N, Dake M, Pritchard WF, Dreher M, Chiesa O, Karanian J, Esparza J, Sharma K, Tang T, Glossop N, Wood BJ. Electromagnetic tracking navigation for thoracic aortic stent graft deployment. Society of Interventional Radiology, San Diego, CA, March 7-12, 2009.

Austin CA, Umbreit TH, Brown KM, Barber DS, Dair BJ, Francke-Carroll S, Feswick A, Saint-Louis, MA, Hikawa H, Goering PL. Distribution of IV-injected silver nanoparticles in pregnant mice and developing embryos. Society of Toxicology Meeting, Baltimore, MD, April 2009.

Badano A, Speaker at the Digital Pathology Advisory Panel meeting, October  2009.

Badano A, Freed M. Computational models of detector response to oblique x-rays compared to measurements for an indirect breast tomosynthesis detector, RSNA 2009, Chicago, IL, 2009. (Oral presentation).

Beard BB. Electromagnetic research at FDA/CDRH: Past, present, and future. Presented at Challenges & Rewards of Wireless Technology in Health Care, FOSE 2009, March 10, 2009.

Beard BB. RFID and medical devices. Presented to the RFID Intra-Government Working Group, Department of Commerce, November 19, 2009.

Benkler S, Kainz W, Guag J, Krauthamer V, Myklebust J, Chang I, Chavannes N, Hwan Kim J, Sarntinoranont M, Kuster N.  Development of a magneto-hydrodynamic solver for anatomical models. IEEE International Symposium on Antennas & Propagation and USNC/URSI National Radio Science Meeting 2009, North Charleston, South Carolina, USA, June 1-5, 2009.

Breger JC, Isayeva I, Pollack SK, Langone LL, Wang NS. Comparison of ionically and novel covalently crosslinked alginate microspheres for cell encapsulation. AIChE, Nashville, TN, November 2009.

Breger JC, Isayeva I, Pollack SK, Langone LL, Wang NS. Novel ‘click’ alginate hydrogels for use as biomaterials. American Chemical Society (ACS), Washington DC, August, 2009.

Carchman IT, Loftin ST, Steen AI, Stratmeyer ME, Brown RP.  Interactive effects between binary mixtures of elastomer extracts.   The Toxicologist 108(1):48, 2009 - Society of Toxicology, 48th Annual Meeting, Baltimore, MD, March 15-19, 2009.

Cabot E, Kainz W, Christ A, Kuehn S, Capstick M, Oberle M, Kuster N. Contributions towards the rigorous RF safety testing of medical implants and MR critical medical devices during MR Exams. BioEM2009, Joint Meeting of the Bioelectromagnetics Society (BEMS) and the European BioElectromagnetics Association (EBEA), Davos, Switzerland, June 14-19, 2009.

Cabot E, Christ A, Lloyd T, Stenzel G, Douglas M, Kainz W, Wedan S, Kuster N. Testing the risk of tissue heating of a generic brain stimulator when exposed to the RF fields of 1.5T MR scanners according to the new technical specification of the ISO/IEC Joint Working Group. The International Society for Magnetic Resonance in Medicine, Seventeenth Scientific Meeting and Exhibition, Stockholm, Sweden, USA, May 1-7, 2009.

Christ A, Kainz W, Neufeld E, Szczerba D, Kuster N. Methodology for the reliable assessment of the exposure of specific groups of the population with known uncertainty. BioEM2009, Joint Meeting of the Bioelectromagnetics Society (BEMS) and the European BioElectromagnetics Association (EBEA), Davos, Switzerland, June 14-19, 2009.

Christ A, Kainz W, Kuster N. Standardized methods for the evaluation of the numerical uncertainty of dosimetric evaluations using the finite-difference time-domain method. BioEM2009, Joint Meeting of the Bioelectromagnetics Society (BEMS) and the European BioElectromagnetics Association (EBEA), Davos, Switzerland, June 14-19, 2009.

Cobb J, Lee A, Tran-Son-Tay R, Sarntinoranont M, Luu HMD. Evaluation of hyaluronic acid-based ocular viscosurgical devices (OVDs) using an in vitro human corneal epithelial cell line model. The American Chemical Society Proceedings Annual Meeting, Washington, DC, August 15-21, 2009.

Coelho SG, Miller SA, Zmudzka BZ, Beer JZ, Hearing VJ. Melanin dispersion to basal keratinocytes may play a role in UV-induced long-lasting pigmentation in human skin. 9th Annual CCR Fellows & Young Investigators Colloquium in Hershey, PA, March 18-20, 2009. (Abstract)

Coelho SG, Miller SA, Zmudzka BZ, Beer JZ, VJ Hearing. Melanin dispersion to basal keratinocytes may play a role in UV-induced long-lasting pigmentation in human skin.  69th Annual Meeting of the Society for Investigative Dermatology, Montreal, Canada, May 6-9, 2009.

Cohen E.  Visual prostheses for the blind: Development of new methods for  assessment of safe and effective retinal stimulation. BIOE seminar, University of Maryland, Department of Engineering, October 29, 2009.

Cohen E.  Presented talk by Bernard Weiss: Neurobehavioral endpoints for assessing the toxic potential of medical device materials. CDER Neurotoxicology Subcommittee Meeting, Silver Spring, MD; also presented at the CDER Neurotoxicology working group on the ASTM conference in Vancouver, British Columbia, Canada, November 12, 2009.

Dair BJ. Nanosilver Research at the FDA. NIST-ERDC Workshop on Nano-Ag. Vicksburg, MS, April 2009.

Dair BJ et al. Effect of medical device material on silver nanoparticle antimicrobial effectiveness. American Chemical Society, August 2009.

Dreher M, Sharma K, Orandi B, Donahue D, Tang Y, Lewis A, Karanian J, Chiesa A, Pritchard W, Wood B. Distribution of image-able beads and doxorubicin following transcatheter arterial chemoembolization. Society of Interventional Radiology, San Diego, CA, March 2009.

Freed M et al. A physical phantom for task-based assessment of breast DCE-MRI: Initial characterization of pre-contrast physical properties at 1.5T, RSNA2009, Chicago, IL, 2009. (Oral presentation)

Gammell PM, Maruvada S, Liu Y, Harris GR. A pre-emphasis technique to broaden the usable frequency range in time delay spectrometry systems. 36th Annual Review of Progress in Quantitative Nondestructive Evaluation (QNDE), Kingston, RI, July 2009.

Gavrielides MA, Zeng R, Kinnard LM, Myers KJ, Petrick N. Estimation of lung nodule size in a volumetric CT phantom study, NIH National Cancer Institute, Bethesda, MD, May 20, 2009.

Giridhar D, Robinson RA, Zderic V, Sliwa J, Myer MR. Noninvasive characterization of HIFU transducers using infrared thermometry.  9th International Symposium on Therapeutic Ultrasound, Aix-in-Provence, France, September 2009.

Godar D, Mitchell D, Agrawal A, Shindell E, Jordan F, Pfefer J, Miller S. UV-emitting medical devices: External versus internal human tissue damage. ASP Symposium on Light and Internal Tissues, 2009.

Goering PL. The impact of nanotechnology on the future of medical devices and medicine. Presented as a webinar under the auspices of the CDRH Office of Science and Biometrics’ MedSun program, September 16, 2009.

Goering PL. Biomarkers of Kidney Injury: Better Tools to Improve Public Health. FDA Press Office Science Writers Day (Presented to 70 invited science writers.)

Grant AM, Sry K, Saager R, Ayers F, Pfefer TJ, Kelly KM, Tseng S-H, Durkin AJ. Diffuse optical spectroscopy of melanoma-simulating silicone phantoms. SPIE Photonics West, 2009.

Guo J, Kim C-S, Brothers K, Saylor DM, Patwardhan DV. The impact of sex-based differences in atherosclerotic plaque on drug elution from drug-eluting stents, FDA Office Of Women’s Health Science Day, Silver Spring, MD, September 25, 2009.

Hariharan P, Myer MR, Banerjee RK. Direct methods for characterizing high-intensity focused ultrasound transducers using acoustic streaming, 9th International Symposium on Therapeutic Ultrasound, Aix-en-Provence, France, September 2009.

Harris GR, Herman BA, Myer MR. An analytical comparison of the thermal dose equation and the intensity-time product, Itm, for predicting tissue damage thresholds. 9th International. Symposium on Therapeutic Ultrasound, Aix-in-Provence, France, September 2009.

Harris GR.  HIFU and regulatory challenges (Invited). 9th International Symposium on Therapeutic Ultrasound, Aix-in-Provence, France, September 2009.

Harris GR. FDA regulation of clinical high intensity focused ultrasound (HIFU) devices, (Invited), Proceedings: 31st Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Minneapolis, MN, September 2009.

Ilev I. Advanced confocal imaging and sensing approaches in biophotonics and nanobiophotonics.  Duke University, Durham, NC, September 16, 2009.

Ilev I. From biophotonics to nanobiophotonics: Advanced imaging and sensing approaches: Confocal imaging and sensing approaches in biophotonics and nanobiophotonics. University of Maryland, College Park, MD, November 19, 2009.

Ilev I. From biophotonics to nanobiophotonics: Breaking the diffraction barrier in the subwavelength nanoscale. Virginia State University (VSU) Seminar on Biophotonics, Petersburg, VA, February 27, 2009.

Isayeva I (invited lecture). Hydrogel-based medical devices Department of Chemistry, College of Staten Island, CUNY, NY, April 30, 2009.

Johnson L, Cohen E, Scribner D, Ilg D, Klein R, Skeath P. A novel high resolution multielectrode array for retinal spike recording using a transconductance amplifier-based focal plane imaging chip. Society for Neuroscience Meeting, October 17-21, 2009.

Kainz W, Benkler S, Guag J, Krauthamer V, Myklebust J, Chang I, Chavannes N, Hwan Kim J, Sarntinoranont M, Kuster N. Magneto-hydrodynamic simulations for non-invasive cardiac blood flow measurement.  BioEM2009, Joint Meeting of the Bioelectromagnetics Society (BEMS) and the European BioElectromagnetics Association (EBEA), Davos, Switzerland, June 14-19, 2009.

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.

Kane JK, Regnault WF. Cochlear implant reliability in the pediatric population: Age group analysis. 12th Symposium on Cochlear Implants in Children, Seattle, WA, June 17-20, 2009.  

Kaplan DS. Regenerative medicine research in the FDA Labs: Towards enhanced monitoring of the chondrocyte phenotype.  Regenerative Medicine Seminar Series, CDRH Staff College, August 2009.

Katz E, Kim DH, Krauthamer V, Ilev I. Effects of optical irradiation parameters on safe peripheral nerve stimulation with infrared light.  SPIE BioPhotonics West, BiOS 2009, San Jose, CA, January 2009

Kim DH, Kang JU, Ilev IK. Advanced confocal fiber-optic imaging and sensing approaches. SPIE BioPhotonics West, BiOS 2009, San Jose, CA, January 2009

Kim D, Kang J, Ilev I. Fiber-optic confocal microscopy methods for various imaging modalities. Metropolitan Biophotonics Symposium, The Catholic University of America, Washington, DC.

Malinauskas RA. Computational fluid dynamics in the evaluation of medical devices: FDA's Critical Path Initiative. American Society for Artificial Internal Organs (ASAIO), Dallas, TX, May 2009.

Maruvada S, Liu Y, Herman BA, Harris GR. Multiple cavitation detection methods for evaluating tissue mimicking materials during HIFU exposure. 9th International Symposium on Therapeutic Ultrasound, Aix-in-Provence, France, September 2009.

McCabe JT, Moratz C, Liu Y, Wahab RA, Egan R, Myer MR. High-intensity focused ultrasound (HIFU) exposure as a model for blast-induced brain injury. Presented at the Society of Neuroscience Annual meeting, Chicago, IL, October 2009.

 

McDermott MK, Kim C-S, Saylor DM, Patwardhan DV, Pollack SK. Effect of drug loading and polymer chemistry on the structure formation of drug-polymer coatings:  Experiments and simulations. Transactions of the 33rd annual Meeting of The Society For Biomaterials, San Antonio, TX, April 22, 2009.

McDermott MK. Effect of drug loading and polymer chemistry on the structure formation of drug-polymer coatings: Experiments and simulations. Transactions of the 33rd annual Meeting of The Society For Biomaterials, San Antonio, TX, April 24, 2009. 

McDermott MK, Kim C-S, Butziger L, Patel L, Saylor DM, Patwardhan DV, Pollack SK. Effect of drug loading and polymer chemistry on the structure formation of drug-polymer coatings:  Experiments and Simulations.  238th ACS National Meeting & Exposition, Washington, DC, August 16-20, 2009.

Myers KJ. Objective evaluation of 3D breast imaging.  Department of Radiology, University of Arizona, February 16, 2009.

Myers KJ. Methods for evaluation of CT dosimetry and DCE-MRI imaging performance. NIH Clinical Center, Department of Radiology, NIH, Bethesda, MD, June 17, 2009.

Nagaraja S, O’Neal, JM, Boskey A, Guldberg RE.  Age-related alterations in mineral/matrix ratio in test-induced             Microdamaged Trabeculae. Orthopaedic Research Society Annual Conference, Las Vegas, NV, February 22, 2009.

Nagaraja S, Harper J, Hall A, Woods T, Chiesa A, Pritchard W, Karanian J, Dreher M. Corrosion and fracture of overlapped stents in a porcine animal model.  ASTM Fretting and Fatigue Workshop, Atlanta, GA, November 2009.

Nagaraja S. Demonstrating safety and efficacy of medical devices: The medical device approval process. Indian Institute of Technology - Mumbai; Mumbai, India, June 2009.

Patwardhan DV (invited speaker). The stuff in medical devices. American Chemical Society Washington, DC, 2009.  

Petrick N, Kinnard LM, Gavrielides MA, Zeng R, Myers KJ. Anthropomorphic phantom experiment for the assessment of nodule volume error: Update on data collection, initial results and the QIBA 1A Reader Study.  Lung Cancer Workshop VI, Bethesda Maryland, May 4-5, 2009.

Petrick N. How does the FDA approach to approving equipment for breast imaging protect health and safety? Do we need a technology assessment institute? RSNA Special Focus Session, December 2009.

Pfefer TJ, Mehrabi A, James R, Landry R, Weininger S, Chang I, Kaufman D, Miller S. Optical-thermal characterization of cutaneous transilluminators. Physics in Medicine and Biology 54:6867-6880, 2009.

Pritchard WF, Constante EJ, Chiesa OA, Chen D, Esparza JA, Karanian JW.  Evaluation of vascular motion of peripheral arteries in swine toward predictive modeling of clinical failure modes. Cardiovascular Research Technologies (CRT), Washington, DC, 2009.

Rasooly A. Optical biosensors for pathogen detection and analysis. SPIE Photonics West Conference in San Jose, CA, 24–29 January 2009.

Rasooly A. Rapid diagnostics in bio-defense - microarrays and proteomics at the Infectious Diseases Society of America (IDSA), Philadelphia, PA, October 31, 2009.

Rasooly A. Emerging Technologies for Detection, Diagnostics and Treatment Conference. NIH-Bethesda, MD, September 10-11, 2009.

Stewart SFC, Day S, Burgreen GW, Paterson EG, Manning KB, Hariharan P, Deutsch S, Giarra M, Cheek C, Reddy V, Berman M, Myer MR, Malinauskas RA. Preliminary results of FDA’s Critical Path project to validate computational fluid methods used in medical device evaluation. American Society for Artificial Internal Organs Annual Meeting, Dallas, TX, May, 2009.

Stewart SFC, Burgreen GW, Paterson EG, Hariharan P, Giarra M, Reddy V, Day S, Manning KB, Deutsch S, Berman M, Myer MR, Malinauskas RA.  Preliminary results of FDA’s round-robin to assess CFD predictions and blood damage in medical devices.  Computational Modeling for Cardiovascular Devices Workshop, Rockville, MD, June 2009.

Tata DB, Waynant RW. A comparative study on confluent and non-confluent human malignant brain cancer metabolic response to He-Ne  laser exposures: evidence for laser-enhanced cellular production of H2O2 and Laser induced “bystander” effect.” [7165-07]   Presented at SPIE- BIOS in Conference 7165–Mechanisms for Low –Light Therapy IV, Chaired by Michael R. Hamblin, Ronald W. Waynant and Juanita Anders, January 24, 2009.

Vesnovsky 0, Demian HW, Woods TO, Topoleski LDT. Molding parameters affect bending strength of spinal bone cement. Transactions of the 2009 Annual Meeting of the Society for Biomaterials, San Antonio, TX, April 2009.

Wang M, Shen J, Chen J, Kainz W, Mendoza G, Bit-Babik G. Electromagnetic compatibility issues between vehicular mounted antennas and implantable medical devices.  BioEM2009, Joint Meeting of the Bioelectromagnetics Society (BEMS) and the European BioElectromagnetics Association (EBEA), Davos, Switzerland, June 14-19, 2009.

Wang Q, Agrawal A, Wang NS, Pfefer J. Condensed Monte Carlo modeling of reflectance spectroscopy with a single illumination-detection fiber.  Conference on Lasers and Electro-Optics,  the Optical Society of America, Baltimore, MD, 2009.

Wang Q, Agrawal A, Wang NS, Pfefer J. Evaluation of a reflectance-based approach for optical property determination in layered tissue.  Proceedings of  SPIE 7170, 71700I, 2009.

Wang Q, Agrawal A, Wang NS, Pfefer J.  Numerical modeling of reflectance-based measurement of optical properties in layered tissues. Metropolitan Biophotonics Symposium. The Catholic University of America, Washington, DC, 2009.

Wang Q, Pfefer J. Numerical and experimental evaluation of an unconstrained approach for UVA-VIS optical property measurement in two-layer mucosal tissue. American Society for Photobiology Topical Symposium American Society for Photobiology and Food and Drug Administration, Rockville, MD, 2009.

Wang Q, Pfefer J. Optical property measurement of internal tissues with a fiberoptic-based UVA-VIS reflectance system.  American Society for Photobiology Topical Symposium, 2009.

Wang Q, Shastri K, Agrawal A, Pfefer J. Numerical and experimental evaluation of an unconstrained approach for UVA-VIS optical property measurement in two-layer mucosal tissue. NIH/SPIE Biophotonics Workshop, 2009.

Wear KA. Ultrasonic scattering from cancellous bone.  3rd European Symposium on Ultrasonic Characterization of Bone, Bydgoszcz, Poland, September 17-18, 2009.  (Invited talk)

Wear KA. Improvements in measurements of BUA and SOS in human calcaneus.  3rd European Symposium on Ultrasonic Characterization of Bone, Bydgoszcz, Poland, September 17-18, 2009. 

Wear KA. Ultrasonic scattering from cancellous bone. Annual Meeting of the Society for Industrial and Applied Mathematics, Denver, CO, July 6-10, 2009.  (Invited talk)

Wear KA. Bob Wagner:  King of Speckle. 34th International Symposium on Ultrasonic Imaging & Tissue Characterization, Arlington, VA, June 10-12, 2009, Ultrasonic Imaging, 31, p. 59, 2009.  (Invited talk)
Wear KA. Lesion detectability in diagnostic ultrasound.  34th International Symposium on Ultrasonic Imaging & Tissue Characterization, Arlington, VA, June 10-12, 2009. Ultrasonic Imaging, 31, p. 59, 2009.  (Invited talk)

Wear KA. Ultrasound contrast agents:  Drugs or devices? American Institute of Ultrasound nd Medicine, Annual Conference, New York, NY, April 3, 2009. (Invited talk)

Witters DM.  Invited presentation - Building consensus towards electronic-mobile-health and patient safety. The 3rd International Symposium on Medical Information & Communication Technology (ISMICT), Montreal, Quebec, Canada, February 25, 2009. 

Witters DM.  Invited presentation - FDA perspectives for wireless mobile healthcare: Building pathways to safe, secure, reliable deployment. TEPR+ 2009, Palm Springs, CA, February 5, 2009.

Witters DM. Invited presentation - Making wireless healthcare safe, effective, and reliable. IEEE EMBS-EMC Joint Section meeting, Baltimore, MD, December 12, 2009.

Witters DM. Invited presentation - Wireless technology: What and how to address in submissions. CBER Workshop on Blood Collection systems, November 5, 2009.

Woods TO.  FDA Update on MRI Labeling for Implants and Devices, International Society for Magnetic Resonance in Medicine (ISMRM) Honolulu, HI, April 2009.