Abbott Gets FDA Breakthrough Device Status For Depression Therapy System

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to investigate the use of Abbott’s ABT deep brain stimulation (DBS) system in treatment-resistant depression (TRD) to manage major depressive disorder (MDD).

The regulatory grant paves way for the deep brain stimulation (DBS) System could possibly available as a new treatment option sooner for people affected by treatment-resistant depression (TRD).

Pedro Malha, Vice President, Neuromodulation, said, “"Breakthrough product development always requires bold thinking and collaboration, and Abbott is fully committed to the journey of providing people with new therapeutic options for their treatment-resistant depression.”

Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.

Further, the Breakthrough Devices designation is applicable for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (De Novo request).

Price Action : Abbott shares are trading higher at $109.54 On Tuesday at the time of publication.