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eZono receives FDA 510(k) clearance for eZono 4000 tablet ultrasound system with eZGuide

  • 2014

eZono AG (›eZono‹), a pri­vate cor­po­ra­tion design­ing, devel­op­ing and dis­trib­ut­ing state of the art tablet ultra­sound sys­tems, today announced it received 510(k) clear­ance from the FDA for its eZono 4000 ded­i­cated pro­ce­dural guid­ance sys­tem with eZGuide tech­nol­ogy, pro­vid­ing any plane free­hand navigation.

The eZono 4000 offers excel­lent image qual­ity and fea­tures eZGuide, a rev­o­lu­tion­ary nee­dle guid­ance pro­vid­ing nee­dle tip loca­tion, with the pre­ci­sion and ease of use that clin­i­cians did not think pos­si­ble in a tablet style sys­tem. »The eZono 4000 with eZGuide, is exceed­ing our expec­ta­tions in per­for­mance and has been wel­comed as game chang­ing tech­nol­ogy by many physi­cians«, says Gra­ham Cox, CEO eZono. »eZono is pas­sion­ate about bring­ing prac­ti­cal and afford­able solu­tions to clin­i­cians in their every­day prac­tice and we are delighted to bring this tech­nol­ogy to the United States for nee­dle guid­ance appli­ca­tions. As health­care costs rise, it becomes imper­a­tive for com­pa­nies to pro­vide qual­ity solu­tions at afford­able prices. eZono addresses the needs of improv­ing patient safety with increased effi­ciency by mak­ing essen­tial equip­ment more eas­ily acces­si­ble with min­i­mal ongo­ing costs per procedure«.

»The eZono 4000 has rev­o­lu­tion­ized the way in which ultra­sound guided pro­ce­dures are per­formed in two ways«, says Dr Jeff Gads­den, Direc­tor of Regional Anes­the­sia St. Luke’s‑Roosevelt Hos­pi­tal Cen­ter, New York. »Firstly, know­ing where your nee­dle tip is at all times rep­re­sents a sub­stan­tial safety advan­tage, both for in-plane and out-of-plane pro­ce­dures. The nee­dle local­iza­tion tech­nol­ogy elim­i­nates the guess­work out of ultra­sound guided tech­niques and reas­sures you that the pro­ce­dure is not going to end in mis­ad­ven­ture. Sec­ondly, we have found the learn­ing curve is accel­er­ated with the eZono 4000 — trainees under­stand ultra­sound guided block tech­niques more quickly when they are trained on the 4000 and are able to demon­strate bet­ter hand-eye coör­di­na­tion skills after sev­eral ses­sions with the machine com­pared to tra­di­tional teach­ing techniques«.


About eZono

eZono AG ( was founded in 2004 and is head­quar­tered in Jena, Ger­many. eZono is a young dynamic com­pany focused on design­ing, devel­op­ing and dis­trib­ut­ing point of care solu­tions. Spe­cial­iz­ing in pro­ce­dural appli­ca­tions, eZono brings a diverse and fresh approach to ultra­sound guid­ance with inno­v­a­tive and unique solu­tions. The com­pany is ded­i­cated to sup­ply­ing sophis­ti­cated solu­tions to address the real needs for point of care clin­i­cians offer­ing state of the art edu­ca­tion, image qual­ity and pre­ci­sion for nee­dle guid­ance in one sys­tem. Visit for more information.

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