Medtronic has received FDA approval for its BrainSense Adaptive Deep Brain Stimulation (aDBS) system.
Medtronic says the technology represents the world’s first closed-loop deep brain stimulation (DBS), brain-computer interface (BCI) technology that adjusts therapy in real-time based on an individual’s brain activity, offering a more personalized approach to managing Parkinson’s symptoms.
The company describes its DBS to be “similar to a cardiac pacemaker, but for the brain.”
It uses a surgically implanted neurostimulator via a minimally invasive procedure to transmit electrical signals to specific parts of the brain affected by debilitating neurological disorders.
Traditional DBS systems provide continuous, unvarying electrical stimulation to targeted brain regions, which may not account for the fluctuating nature of Parkinson’s symptoms or the effects of medication cycles.
In contrast, Medtronic’s aDBS system offers personalized therapy based on a patient’s brain activity in real time, both in clinical settings and in daily life. It monitors brain signals and automatically modifies stimulation levels to align with the patient’s immediate needs — reducing manual adjustments required by the patient — potentially enhancing symptom control and reducing side effects.
After more than a decade in development, the BrainSense aDBS system received CE mark approval in Europe this January.
XTALKS WEBINAR: Revolutionizing Medical Devices with Hydrophilic Vascular Coatings: Advancing Patient Care and Performance
Live and On-Demand: Wednesday, March 5, 2025, at 9am EST (3pm CET/EU-Central)
Register for this free webinar to discover the latest advancements in hydrophilic vascular coatings in this comprehensive webinar tailored for professionals in the medical device industry.
The FDA’s approval of the BrainSense system is supported by data from the ADAPT-PD trial, a comprehensive study evaluating the safety and effectiveness of aDBS in various settings. The trial demonstrated that the aDBS system could provide more precise management of Parkinson’s symptoms by adjusting stimulation in response to real-time brain activity.
In addition to the aDBS system, both the FDA and European approvals include the BrainSense Electrode Identifier (EI), a tool designed to optimize the initial programming of DBS therapy.
By providing clinicians with a real-time snapshot of a patient’s brain signals, the EI facilitates more accurate electrode placement and is approximately 85% faster compared to traditional methods.
Medtronic says this feature can reduce the time patients spend in the clinic for DBS calibration by displaying their individual neural activity.
Brett Wall, executive vice president and president of Medtronic’s Neuroscience Portfolio, emphasized the significance of the approval, saying “Medtronic is the only company in the world to offer an aDBS system that dynamically adjusts therapy in real time.”
“This new era in Parkinson’s care represents more than a decade of intentional innovation — ushering in personalized neuromodulation at scale that responds to a patient’s changing needs, equipping clinicians with unparalleled insights and setting a new standard for DBS therapy.”
Related: Top 20 Publicly Traded Medical Device Companies by Market Cap in 2025
BrainSense will be available through Medtronic’s Percept neurostimulator implants.
In 2021, Medtronic received FDA approval for DBS hardware capable of sensing and recording local electric field potential changes.
The adaptive program can be programmed as a software update into devices that have already been implanted.
Coinciding with the CE mark approval earlier this year, Medtronic announced that the first patient began using the feature on the same day.
With over 40,000 DBS patients worldwide using Medtronic Percept devices, BrainSense aDBS marks the largest commercial launch of BCI technology to date.
Medtronic plans to begin patient programming with the aDBS system at select healthcare centers in the coming weeks, with broader availability anticipated in the upcoming months.
If you want your company to be featured on Xtalks.com, please email [email protected].
Join or login to leave a comment
JOIN LOGIN