Ultrasound in Medicine and Biology
Volume 36, Issue 8 , Pages 1224-1228 , August 2010

Safety and U.S. Regulatory Considerations in the Nonclinical Use of Medical Ultrasound Devices

Received 11 May 2009 ,Revised 15 March 2010 ,Accepted 31 March 2010.

References 

  1. Abramowicz JS, Fowlkes JB, Skelly AC, Stratmeyer ME, Ziskin MC. Conclusions regarding epidemiology for obstetric ultrasound. J Ultrasound Med. 2008;27:637–644
  2. AIUM Bioeffects Committee . American Institute of Ultrasound in Medicine consensus report on potential bioeffects of diagnostic ultrasound: Executive summary. J Ultrasound Med. 2008;27:503–515
  3. Ang ESBC, Gluncic V, Duque A, Schafer ME, Rakic P. Prenatal exposure to ultrasound waves impacts neuronal migration in mice. Proc Nat Acad SciE. 2006;103:12903–12910
  4. Barzelai S, Sharabani-Yosef O, Holbova R, Castel D, Walden R, Engelberg S, et al. Low-intensity ultrasound induces angiogenesis in rat hind-limb ischemia. Ultrasound Med Biol. 2006;32:139–145
  5. Crisci AR, Ferreira AL. Low-intensity pulsed ultrasound accelerates the regeneration of the sciatic nerve after neurotomy in rats. Ultrasound Med Biol. 2002;28:1335–1341
  6. Fatemi M, Ogburn PL, Greenleaf JF. Fetal Stimulation by pulsed diagnostic ultrasound. J Ultrasound Med. 2001;20:883–889
  7. FDA, Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers, Sept. 9, 2008.
  8. Feril LB, Tachibana K, Ogawa K, Yamaguchi K, Solano IG, Irie Y. Therapeutic potential of low-intensity ultrasound (Part 1): Thermal and sonomechanical effects. J Med Ultrason. 2008;35:153–160
  9. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF. Acceleration of tibial fracture-healing by noninvasive, low-intensity pulsed ultrasound. J Bone Joint Surg [AM]. 1994;76:26–34
  10. Ito M, Azuma Y, Ohta T, Komoriya K. Effects of ultrasound and 1,25-dihydroxyvitamin D3 on growth factor secretion in co-cultures of osteoblasts and endothelial cells. Ultrasound Med Biol. 2000;26:161–166
  11. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. J Bone Joint Surg [AM]. 1997;79-A:961–973
  12. Leung KS, Lee WS, Tsui HF, Liu PPL, Cheung WH. Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound Med Biol. 2004;30:389–395
  13. Newnham JP, Doherty DA, Kendall GE, Zubrick SR, Landau LL, Stanley FJ. Effects of repeated prenatal ultrasound examinations on childhood outcome up to 8 years of age: Follow-up of a randomized controlled trial. Lancet. 2004;364:2038–2044
  14. Romano CL, Romano D, Logoluso N. Low-intensity pulsed ultrasound for the treatment of bone delayed union or nonunion: A review. Ultrasound Med Biol. 2009;35:529–536
  15. Sena K, Leven RM, Mazhar K, Sumner DR, Virdi AS. Early gene response to low-intensity pulsed ultrasound in rat osteoblastic cells. Ultrasound Med Biol. 2005;31:703–708
  16. Takakura Y, Matsui N, Yoshiya S, Fujioka H, Muratsu H, Tsunoda M, et al. Low-intensity pulsed ultrasound enhances early healing of medial collateral ligament injuries in rats. J Ultrasound Med. 2002;21:283–288
  17. Takikawa S, Matsui N, Kokubu T, Tsunoda M, Fujioka H, Mizuno K, et al. Low-intensity pulsed ultrasound initiates bone healing in rat nonunion fracture model. J Ultrasound Med. 2001;20:197–205
  18. Warden SJ, Bennell KL, McMeeken JM, Wark JD. Acceleration of fresh fracture repair using the sonic accelerated fracture healing system (SAFHS): A review. Calcif Tissue Int. 2000;66:157–163
  19. Zhang ZJ, Huckle J, Francomano CA, Spencer RGS. The effects of pulsed low-intensity ultrasound on chondrocyte viability, proliferation, gene expression and matrix production. Ultrasound Med Biol. 2003;29:1645–1651

PII: S0301-5629(10)00142-0

doi: 10.1016/j.ultrasmedbio.2010.03.020

Ultrasound in Medicine and Biology
Volume 36, Issue 8 , Pages 1224-1228 , August 2010