Medtronic Secures FDA Approval for BrainSense™ Adaptive DBS, Pioneering Largest BCI-Enabled Therapy Launch

Medtronic plc, a global leader in healthcare technology, has announced U.S. Food and Drug Administration (FDA) approval for BrainSense™ Adaptive Deep Brain Stimulation (aDBS) and BrainSense™ Electrode Identifier (EI). This marks the largest commercial launch of brain-computer interface (BCI) technology to date, bringing an innovative, real-time, self-adjusting DBS therapy to patients with Parkinson’s disease (PD) and other neurological disorders.

With one million people diagnosed with Parkinson’s disease in the U.S. alone, the approval represents a significant milestone in advancing treatment options. While DBS has been a transformative therapy for over 30 years, Medtronic’s latest enhancement—BrainSense™ Adaptive technology—elevates Percept™ DBS neurostimulators to provide personalized therapy that adjusts dynamically to a patient’s real-time brain activity. This reduces the need for manual adjustments and ensures optimal symptom control in clinical and everyday settings.

Transforming Parkinson’s Care with Real-Time Adaptive Therapy

“Medtronic is the only company in the world offering an adaptive DBS system that dynamically adjusts therapy in real time,” said Brett Wall, Executive Vice President and President of the Medtronic Neuroscience Portfolio. “This new era in Parkinson’s care reflects more than a decade of dedicated innovation, ushering in personalized neuromodulation at scale, equipping clinicians with unprecedented insights, and setting a new standard for DBS therapy.”

With over 40,000 patients using Medtronic’s Percept™ DBS devices worldwide, BrainSense™ Adaptive DBS represents an unprecedented expansion of BCI-enabled therapy. By detecting and classifying distinct brain signals, Medtronic positions itself at the forefront of BCI-integrated DBS therapy, focusing on rehabilitation and symptom management.

Clinical Backing & Expert Endorsements

The ADAPT-PD trial, led by global principal investigator Dr. Helen Bronte-Stewart (Stanford University School of Medicine), validated the safety and effectiveness of adaptive DBS versus continuous DBS in a rigorous, multi-center, randomized crossover study. The trial, which spanned leading institutions such as Stanford, UCSF, Massachusetts General Hospital, and Amsterdam University Medical Center, stands as the most extensive and longest-running assessment of aDBS conducted in both clinical and home settings.

“Adaptive deep brain stimulation represents a major advancement in Parkinson’s treatment,” said Dr. Bronte-Stewart. “The ability to automatically tailor therapy to a patient’s evolving needs significantly improves outcomes and quality of life.”

Enhancing Precision with BrainSense™ Electrode Identifier

Alongside aDBS, BrainSense™ Electrode Identifier (EI) received FDA approval to optimize DBS programming with enhanced efficiency. EI allows clinicians to identify electrode placement 85% faster than traditional selection methods, significantly reducing in-clinic programming time and providing a more precise, personalized therapy experience.

“BrainSense™ Electrode Identifier offers a real-time snapshot of a patient’s brain signals, streamlining programming and ensuring greater accuracy in therapy customization,” said Dr. Drew Kern, Neurologist at the University of Colorado School of Medicine.

Expanding Access to Personalized DBS Therapy

“This approval marks another milestone in our commitment to advancing sensing-enabled personalized treatments for Parkinson’s patients,” said Amaza Reitmeier, Vice President and General Manager of the Medtronic Neuromodulation Portfolio. “With both FDA and CE Mark approval, we continue to transform therapeutic possibilities for individuals with movement disorders and epilepsy.”