Nov 7, 2019

Shreis Scalene Sciences, a medical device manufacturer based in Gaithersburg, Maryland, has obtained Breakthrough Device Designation from the US Food and Drug Administration for its Cytotron® device for treating solid breast, liver and pancreatic tumors.

With consulting support from Emergo by UL, Shreis successfully applied for qualification of Cytotron® for FDA’s Breakthrough Devices Program. The program entails collaboration between manufacturers of cutting-edge devices and FDA staff early in product development to ensure more efficient 510(k) clearance or Premarket Approval (PMA).

Learn more about Shreis’s FDA Breakthrough Device designation for Cytotron® here.

 

Author

  • Stewart Eisenhart

Related