July 6, 2017 / 12:27 PM / 2 months ago

BRIEF-Isoray receives FDA response to application for Gammatile

July 6 (Reuters) - Isoray Inc

* Isoray receives FDA response to 510(k) application for Gammatile

* Has received a response from FDA regarding company's pending application for Gammatile radiation therapy system

* FDA indicated need for co, co-applicant, to submit additional data within next 180 days as condition of securing clearance for novel Gammatile device

* As a result of FDA's response, pending ntap application, which requires an FDA cleared product, will be resubmitted in fall of 2017

* Completion of additional testing anticipated by end of 2017, project potential 510(k) clearance of Gammatil product in first half of 2018 Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below