Brooklyn Park-based medical technology firm ShiraTronics Inc. has received a Breakthrough Device designation from the FDA for its neurostimulation therapy for treating migraine headaches it announced Monday.
The program helps certain products that treat life-threatening or disabling conditions progress through the FDA approval process more quickly. The FDA collaborates closely with organizations that receive the designation, and they can expect to have their eventual submission for FDA approval expedited.
"We are thrilled to have received this important designation from the FDA. This reinforces the severity of the disability these patients suffer and the importance of new therapy options," CEO Lynn Elliott said in a statement.
ShiraTronics has largely flown under the radar, but the firm had one of 2019's largest venture capital raises in a $33 million Series A round. That round was led by U.S. Venture Partners, Amzak Health and Strategic HealthCare Investment Partners. It raised an additional $3 million in March 2020 from Breakout Ventures.
ShiraTronics is a spinout of NuXcel, a medical-device manufacturer based in Minneapolis and Ireland. ShiraTronics is led by Elliott, a former executive at Guidant, Boston Scientific and Spinal Modulation.
