A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Brain Stimulation

Active implantable medical devices for brain stimulation

Actually, is micromagnetic neural stimulation really a thing?

Posted on by Posted in Brain Stimulation, Magnetic Stimulation
Principle of micromagnetic stimulation

Image Credit: Cleveland Clinic Center for Medical Art and Photography

After attending NANS2025 I posted about work being done by various universities and at least one startup company on “micromagnetic stimulation” (μMS).

However, yesterday I received an e-mail from Dr. Bradley Roth from Oakland University. He shared with me two interesting papers in which he and his PhD student Mohammed Alzahrani calculated that the electric field induced by microcoils in the brain would be too small to excite neurons, and thus posits that stimulation in experimental studies may be the result of capacitive coupling.

From Alzahrani M, Roth BJ. The Electric Field Induced by a Microcoil During Magnetic Stimulation. IEEE Trans Biomed Eng. 2023 Nov;70(11):3260-3262 :

“Abstract

Objective: The purpose of this study is to calculate the electric field produced by an implanted microcoil during magnetic stimulation of the brain.

Methods: The electric field of a microcoil was calculated numerically.

Results: The maximum value of the induced electric field is approximately 0.000026 V/m for a 1 mA, 3 kHz current passed through the coil.

Conclusion: This electric field value is too small to cause neural stimulation.

Significance: Previous studies reporting magnetic stimulation using a microcoil must have been exciting neurons by some other mechanism.”

The other paper which describes the core of Mohammed Alzahrani’s dissertation is: The Calculation of Maximum Electric Field Intensity in Brain Tissue Stimulated by a Current Pulse through a Microcoil via Capacitive Coupling, which is available as an open access article.

As I mentioned in my original post:

“Many years ago I built a magnetic nerve stimulator that dumped a large bank of capacitors (2,100 μF) charged to 1,350V into a coil of very hefty litz wire.  rTMS devices, which stimulate the brain with similar magnetic pulses at a frequency of around 10Hz require water-cooled coils.

Based on this experience, I wouldn’t have thought that magnetic stimulation could be scaled into something that could be implanted. “

My gut feeling may have been right after all…

Thank you Brad for bringing your work to my attention!  I’ll keep my eyes open and report about developments in this field.

Precision Neuroscience receives FDA approval for temporary implant of Layer 7 interface

Posted on by Posted in ALS, Brain Stimulation, Brain-Computer Interface, Precision Neuroscience, Traumatic Brain Injury
Precision Neuroscience's Layer 7 interface

Image Credit: Precision Neuroscience

Precision Neuroscience is a brain–computer interface (BCI) company based in New York City founded by Dr. Benjamin Rapoport (one of Neuralink’s founding members) and Michael Mager in 2021.

Precision is developing a BCI system with a minimally-invasive electrode array built on a thin, flexible film that can be slotted through a sub-millimeter incision and placed nearly anywhere on the surface of the brain in a reversible procedure. Precision claims that the electrodes are capable of both recording information as well as stimulating neural activity.  Precision Neuroscience aims to treat neurological conditions such as spinal cord injury, stroke, and neurodegenerative diseases such as ALS and traumatic brain injury.

Precision Neuroscience recently announced that it had received FDA’s clearance to implant its Precision’s Layer 7 minimally-invasive interface as a temporary implant for use up to 30 days, which will allow it to be used for brain mapping during open surgery and gain further experience as it continues to develop its BCI system.

Newronika receives CE for AlphaDBS for the treatment of Parkinson’s disease

Posted on by Posted in Brain Stimulation, Newronika, Parkinson's Disease
Newronika's DBS device for treatment of Parkinson's

Image Caption: Newronika

Newronika, was founded in 2016 to develop adaptive deep-brain stimulation technology.  The Company is the spin-off company of two Italian research institutions, the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico Hospital and the University of Milan.

Earlier this week Newronika announced that it received CE Mark approval for its AlphaDBS device for the treatment of Parkinson’s disease (PD).

Unlike open-loop DBS stimulators, Newronika’s AlphaDBS  senses local field potentials (LFPs)  to adapt the stimulation in real-time to optimize the patient’s clinical condition.

The CE Mark approval was supported by clinical data showing that patients experienced an extended period of time without symptoms or side effects as compared to conventional, open-loop DBS.  Patients reported enhanced quality of life and a preference for the adaptive stimulation mode.

The AlphaDBS rechargeable IPG has 2 channels for recording LFPs, 1 week of memory capacity for biomarker trend and spectrogram, and 16 current-independent channels for DBS.

 

FDA Approves Medtronic’s Adaptive DBS for treating Parkinson’s

Posted on by Posted in Brain Stimulation, Medtronic, Parkinson's Disease
Medtronic Percept RC rechargeable DBS IPG www.implantable-device.com

Image Credit: Medtronic

Medtronic announced that it received FDA’s approval of its BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI), which personalize therapy based on a patient’s brain activity in real time – both in clinical settings and in daily life. aDBS is meant to automatically adjust therapy for symptom control, minimizing the need for patients to manually adjust stimulation.

BrainSense™ Adaptive DBS is available to Medtronic DBS patients with Parkinson’s who have been implanted with a Percept™ neurostimulator, as well as future Medtronic DBS patients.

Is DBS business in trouble? Yes, according to Duke’s Cameron McIntyre

Posted on by Posted in Academic, Brain Stimulation, Depression, Epilepsy, Parkinson's Disease, Stroke
DBS electrodes in skull

Image credit: Modified from https://commons.wikimedia.org/wiki/File:Tiefe_Hirnstimulation_-_Sonden_RoeSchaedel_ap.jpg

I attended the “Engineering Principles of Deep Brain and Spinal Cord Stimulation” workshop at NANS 2025, and was very impressed by Dr. Cameron McIntyre’s presentation where he analyzed the state of the DBS market.

Dr. McIntyre showed that the cost of developing DBS technology over the past two decades was justified by the expected market growth.  However, the DBS market is not growing anywhere near the rate at which it was expected.  In 2024 it had barely returned to 2019 numbers after it sharply decreased during COVID, and is now projected to stay flat for years to come.

The existential threats to DBS are:

  • Anemic growth,
  • High-Intensity Focused Ultrasound (HIFU),
  • Infusions, and
  • “Magical” biologics

The main issue is that although DBS is the best therapy for Parkinson’s, the vast majority of patients refuse it because they feel that it is too invasive.  Instead, they are lured to High-Intensity Focused Ultrasound (HIFU) because, although in Dr. McIntyre’s view it is a”silly concept,” it promises to be a quick fix.

In Dr. McIntyre’s view, if DBS doesn’t find new indications, investment will shrink and its market will drop to half within 5 years.  These new indications could include epilepsy, depression, and stroke.

Another major factor that is causing DBS’ decline is its currently overcomplicated clinical workflow.  Dr. McIntyre believes that in order to survive, a major paradigm shift is needed to standardize DBS surgery and automatize DBS management.

 

Neuralink receives FDA’s Breakthrough Device designation for its Blindsight Device

Posted on by Posted in Blindness, Brain Stimulation, Neuralink
Neuralink implant

Image credit: Neuralink

Yesterday Neuralink announced that its Blindsight Device had been granted “Breakthrough Device” designation by the FDA.  According to Elan Musk, the device “will enable even those who have lost both eyes and their optic nerve to see.”

Details about the Blindsight Device or commencement of a clinical trial are scarce at this time.

Abbott starts clinical trial of DBS to treat depression

Posted on by Posted in Abbott, Brain Stimulation, Depression
Abbott St Jude Medical Infinity DBS IPG

Image Credit: Abbott

Back in 2022, the FDA granted Abbott Breakthrough Device designation for deep brain stimulation (DBS) for treatment-resistant depression (TRD), a form of major depressive disorder.  Now Abbott announced it has initiated a pivotal clinical trial, called the TRANSCEND study, to evaluate the use of the company’s DBS system to manage TRD.

Previous open-label studies exploring the use of DBS for TRD have shown at least a 50% sustained improvement in symptoms of depression for three out of four people over a period of two to eight years.

Continue reading→

Picostim DBS device implanted in child with Lennox-Gastaut syndrome

Posted on by Posted in Amber Therapeutics, Bioinduction, Brain Stimulation, Epilepsy, Lennox-Gastaut syndrome
Picostim DyNeuMo

Image Credit: Zamora et al https://doi.org/10.1101/2020.09.10.292284

UK news outlets reported that a Picostim deep-breain stimulator made by UK company Bioinduction (which was recently acquired by Amber Therapeutics) was recently implanted in a boy with Lennox-Gastaut syndrome, which is a  a severe,  treatment-resistant form of epilepsy that he developed at the age of three.

The implant was performed at the UCL Great Ormond Street Institute of Child Health & Great Ormond Street Hospital under the “CADET” project (Children’s Adaptive Deep brain stimulation for Epilepsy Trial).  According to the project’s website, the Picostim system is especially suitable for DBS therapy in this application:

  1. “The advanced capabilities of Picostim DyNeuMo-1 allow for personalised and adaptive stimulation regimes according to seizure patterns and circadian (wake/sleep) rhythms at an individual patient level, which are key components of LGS symptoms. These capabilities are here proposed to maximize the potential of DBS to limit seizure spread, and reduce seizure frequency and severity.

  2. These capabilities are made possible by the ability to non-invasively and repeatedly recharge the device. Patients or parents are able to use a handheld or headset-mounted charger that safely recharges the battery through the skin.

  3. The device allows for the recording of electrical activity in the implanted brain, potentially allowing stimulation parameters that are tailored to LGS and to the individual child.

  4. Lastly, the whole device is mounted to the skull, removing the need for (painful) tunneling of extension leads to a battery implanted in the chest wall and potentially reducing the risk of infection.”

The CADET pilot (Children’s adaptive deep brain stimulation for epilepsy trial) will now recruit three additional patients with Lennox-Gastaut syndrome, with a view to 22 patients being recruited to take part in a full trial.

 

 

CADET Project is using a cranially-mountedPicostim DBS device

Image Credit: CADET Project, UCL Great Ormond Street Institute of Child Health

 

CorTec’s Closed-Loop Brain Interchange system receives IDE approval for use in rehabilitation from stroke

Posted on by Posted in Brain Stimulation, CorTec, Stroke
CorTec Closed-Loop Brain Interchange implant system

Image Credit: CorTec

CorTec is a neurostimulation company based in Freiburg, Germany developing the closed-loop “Brain Interchange Implant System.”  This is an implantable device is capable of recording and stimulating on 32 channels under the wireless control of an External Unit which also powers the device.  Application Software on a computer connected to the External Unit manages the telemetry and analyzes signals acquired by the implant.  The computing unit then uses parameters provided by the application software to generate stimuli in the brain and nerves.

CorTec announced  that the US FDA approved and IDE application by the University of Washington School of Medicine to use the Brain Interchange Implant System as a novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity within the brain. Continue reading→

China’s Evolving Domestic AIMD Industry

Posted on by Posted in Aerospace Taixin Technology, AIMD Business, Bradycardia, Brain Stimulation, Cardiac Contractility Modulation, Cardiac Pacing, Cardioversion/Defibrillation, CH Biomedical (Tongxin Medical Equipment), Circulatory Support, Cochlear Stimulation, Core Medical Technology, CoreRhythm, General Stim, Genlight, Hearing Impairment, Heart Failure (CHF), Leadinno Medical Valley, Lepu Medical, Lifetech Scientific, Microport, Nerve Blocking, Nurotron, Nystagmus, Pain, Parkinson's Disease, PINS Medical, PNS, Qinming Medical, Rectus Muscle Stimulation, Rishena Medical, Rocor Medical Technology, Sacral Root Stimulation, Sceneray, Seeneuro, Singular Medical, Sneuro, Spinal Cord Stimulation, Super Vision, Tachycardia, Vagus Nerve Stimulation, Yongrenxin

AIMDs made in China www.implantable-device.com

The 2015 “Made in China 2025” and subsequent domestic development initiatives have significantly benefited Chinese medical device manufacturers.  The 2015 plan  prioritized the expansion of high-tech device production with the goal of supplying 70% of China’s device market by 2025.   More recently, in 2021, the Chinese government issued the 14th  five-year plan (2021–25) that aims at making at least six Chinese companies reach the top 50 revenue-making medical device companies globally.

I was recently chatting with Victor Pikov at the First AIMD Workshop, and he mentioned that in the last couple of years the number of Chinese AIMD manufacturers have grown from 5 to over 10.  I was really surprised about the progress that China has made in the AIMD field, so this blog expands on the list of Chinese AIMD companies that Victor compiled and kindly shared with me. Continue reading→

FDA Approves Abbott’s Liberta RC DBS System

Posted on by Posted in Abbott, Brain Stimulation, Movement Disorders, Parkinson's Disease
Abbott Liberta RC DBS IPG

Image Credit: Abbott

Abbott announced that it received FDA’s approval for its Liberta RC DBS system, which is the world’s smallest rechargeable deep brain stimulation (DBS) device with remote programming, to treat people living with movement disorders.  According to the press release:

“At approximately the height and width of a smartwatch face, the Liberta RC DBS system is about 31% smaller than other commonly used implantable, rechargeable DBS devices currently available in the U.S.  When used under standard settings, Abbott’s Liberta RC DBS system needs to be recharged as few as every 37 days – or 10 times a year – using a wireless charger that is placed over the device. For users who prefer a weekly charging schedule, only 30 minutes of charging is needed. The wireless charging system allows people to be active while wearing it and can fully recharge the Liberta RC DBS system twice before needing to be plugged in again. The system, which can be controlled on an Abbott supplied patient controller or a compatible and secure iOS device, offers users helpful notifications and customizable settings for a personalized charging experience”

 

Motif Neurotech Raises $18.75M to Fund R&D and Clinical Study of Device to Treat Depression

Posted on by Posted in AIMD Business, Brain Stimulation, Depression, Motif Neurotech
Motif brain stimulator for depression

Image Credit: Motif

Rice University announced that Motif Neurotech, which was formed through the Rice Biotech Launch Pad, closed a Series A financing round of $18.75 million.  According to the press release:

“Proceeds from the Series A financing will be used to advance the development of Motif’s lead product, the DOT microstimulator, a miniature brain pacemaker that is designed to precisely stimulate the brain to restore healthy circuit activity to treat mental health disorders. The initial indication Motif is pursuing for the device is treatment-resistant depression (TRD), a form of major depressive disorder (MDD).”

 

FDA Approved Medtronic’s Percept™ RC Rechargeable DBS IPG

Posted on by Posted in Brain Stimulation, Epilepsy, Essential Tremor, Medtronic, OCD, Parkinson's Disease
Medtronic Percept RC rechargeable DBS IPG www.implantable-device.com

Image Credit: Medtronic

Medtronic announced the FDA approval of its Percept™ RC rechargeable Deep Brain Stimulation (DBS) system. Ths sensing-enabled IPG allows the physician to personalize treatment for patients with movement disorders such as Parkinson’s disease, essential tremor, and dystonia, as well as epilepsy.

According to the press release:

“Percept™ RC is the smallest and thinnest dual channel neurostimulator available for DBS. It is equipped with BrainSense™ technology that captures and records brain signals to provide insights that enable a healthcare provider to adapt and personalize therapy to a patient’s evolving needs. Unlike other rechargeable devices, the Percept™ RC battery offers at least 15 years of service life with consistent and fast recharge performance. Medtronic patented battery technology has less battery fade than other rechargeable devices for a more reliable, long-lasting battery. Patients can experience rapid recharging from 10% to 90% full charge in less than an hour.”

“Pea-Sized” Brain Stimulator Being Developed by Motif for Treating Depression

Posted on by Posted in Brain Stimulation, Depression, Motif Neurotech
Motif brain stimulator for depression

Image Credit: Motif Neurotech

Motif Neurotech, based in Houston, TX is developing a “pea-sized” implantable brain stimulator intended for the treatment of depression.

An interesting preprint was published by Motif’s engineers in collaboration with researchers at Rice University, Baylor College of Medicine, and UTHealth Houston on their millimeter-sized battery-free epidural cortical stimulators.  The paper discusses the engineering of the implant, a 30-day porcine study, as well as an intra-operative human test of the device.

Motif’s concept is to implant the device through a simple outpatient procedure, and having the patient periodically wear at home a headset that transmits power to the implant to deliver episodic neuromodulation.

OT: My New Book on Near-IR Treatment of Brain Disorders is Now Available

Posted on by Posted in Alzheimer's, Brain Stimulation, David Prutchi's Portfolio, Dementia, Depression, Ischemic Stroke, My Portfolio, Opioid Overdose, Stroke

My new book is out and available through Amazon!

High-Power Near-Infrared Light Treatments for Depression, Dementia, and Other Brain Disorders

Light of specific wavelengths and intensities has been shown to repair and protect neurons from damage, opening the possibility of using near-infrared light as a non-invasive treatment of various brain and psychiatric disorders.

This book serves as a practical overview of the scientific fundamentals, technical implementation, and therapeutic applications of transcranial photobiomodulation:

  • Part I provides an accessible explanation of why the irradiation must be done in the near-infrared region of the light spectrum. It presents evidence-based background on the parameters of light important to photobiomodulation, and describes the effects of near-infrared light on cells and tissues.
  • Part II discusses the types of multi-Watt light sources required to non-invasively deliver therapeutic doses of infrared light to the brain. Importantly, this part describes in detail various High-Power Near-Infrared Transcranial Therapy (HIPNITT) medical devices that have been used in clinical trials.
  • Part III presents the potential and challenges of using near-infrared light in the treatment of various brain disorders such as depression, dementia, traumatic brain injury, and Parkinson’s disease.

This book uses straightforward language and offers practical guidance to help readers quickly develop an understanding of the practical aspects of HIPNITT implementation and its therapeutic applications.