Evren Technologies this week announced that it received FDA breakthrough device designation for its Phoenix earbud device that treats PTSD.
Gainesville, Fla.-based Evren Technologies designed the Phoenix device as a discreet earbud design that delivers transcutaneous auricular vagal nerve stimulation in a closed-loop system. It can be paired with the company’s PTSD symptom tracking app to allow for reimbursable remote clinician monitoring and the establishment of a PTSD database.
“Evren is committed to human-centered design for our Phoenix earbud, as well as pursuing sound clinical research to prove the benefits, useability, safety, and effectiveness of our technology,” cofounder and CEO Blythe Karow said in a news release. “We look forward to our pivotal trial next year and to applying for marketing approval under the De Novo Classification program.”