Scientific Publications by FDA Staff

Recent Scientific Publications: Medical Devices

• Biomed Eng Online 2013 Feb 9;12:12
  Numerical investigations of MRI RF field induced heating for external fixation devices.
• Acad Radiol 2013 Apr 20 [Epub ahead of print]
  Statistical Power Considerations for a Utility Endpoint in Observer Performance Studies.
• Stat Methods Med Res 2013 Apr 16 [Epub ahead of print]
  Linear combination methods to improve diagnostic/prognostic accuracy on future observations.
• Comput Stat Data Anal 2013 Jun;62:39-51
  Estimation of the volume under the ROC surface with three ordinal diagnostic categories
• Am J Transplant 2013 Apr 8 [Epub ahead of print]
  Summary of FDA Workshop on Ischemia Reperfusion Injury in Kidney Transplantation.
• J Pharm Sci 2013 Apr 9 [Epub ahead of print]
  Impact of artificial plaque composition on drug transport.
• Diabetes Technol Ther 2013 Apr;15(4):348
  FDA Supports Standardized Reporting and Analysis on CGM Devices.
• Ophthalmology 2013 Mar;120(3):652-3
  Enzymatic Detergents and Toxic Anterior Segment Syndrome - Reply
• Am Heart J 2013 Mar;165(3):344-353
  TransRadial Education And Therapeutics (TREAT): Shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention: A report from the Cardiac Safety Research Consortium.
• J Biomed Mater Res B Appl Biomater 2013 Apr 6 [Epub ahead of print]
  Impact of copolymer ratio on drug distribution in styrene-isobutylene-styrene block copolymers.
• Ophthalmology 2013 Mar;120(3):654
  United States Food and Drug Administration TASS Program - Reply
• JOM 2013 Apr;65(4):550-6
  Prevention of Ultraviolet (UV)-Induced Surface Damage and Cytotoxicity of Polyethersulfone Using Atomic Layer Deposition (ALD) Titanium Dioxide
• J Acoust Soc Am 2013 Apr;133(4):2490-501
  Estimation of fast and slow wave properties in cancellous bone using Prony's method and curve fitting.
• J Biomed Mater Res B Appl Biomater 2013 Apr 4 [Epub ahead of print]
  Comparative stability of the bioresorbable ferric crosslinked hyaluronic acid adhesion prevention solutions.
• J Biomed Mater Res A 2013 Mar 27 [Epub ahead of print]
  Different molecular weight hyaluronic acid effects on human macrophage interleukin 1beta production.
• J Magn Reson Imaging 2013 Mar;37(3):501-30
  ACR guidance document on MR safe practices: 2013.
• J ECT 2013 Mar 20 [Epub ahead of print]
  A Double-blind, Placebo-Controlled Study of the Impact of Galantamine on Anterograde Memory Impairment During Electroconvulsive Therapy.
• Mutat Res 2013 Jan-Mar;752(1):6-9
  Harnessing genomics to identify environmental determinants of heritable disease.
• Adv Healthc Mater 2013 Feb;2(2):334-42
  Micropatterning different cell types with microarray amplification of natural directional persistence.
• Leuk Lymphoma 2013 Mar;54(3):579-86
  Quantitative detection of zeta-chain-associated protein 70 expression in chronic lymphocytic leukemia.
• Med Phys 2013 Mar;40(3):031907
  Validation of columnar CsI x-ray detector responses obtained with hybridMANTIS, a CPU-GPU Monte Carlo code for coupled x-ray, electron, and optical transport.
• J Vasc Surg 2013 Mar;57(3):823-5
  Application of Investigational Device Exemptions regulations to endograft modification.
• Chem Rev 2013 Mar 13;113(3):1904-2074
  Functionalizing Nanoparticles with Biological Molecules: Developing Chemistries that Facilitate Nanotechnology.
• Drug Metab Rev 2013 Feb 25 [Epub ahead of print]
  Challenges in exploring the cytochrome P450 system as a source of variation in canine drug pharmacokinetics.
• Biometrics 2013 Feb 22 [Epub ahead of print]
  A Causal Model for Joint Evaluation of Placebo and Treatment-Specific Effects in Clinical Trials.