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

Category Archives: Neural Stimulation

AIMDs for the stimulation of the nervous system

Boston Scientific acquires Nalu for $533M

Posted on by Posted in Boston Scientific, Nalu, Pain, PNS, Spinal Cord Stimulation

Image Credit: Nalu

Nalu Medical, Inc. is a privately held, early-stage start-up based in Carlsbad, California. They developed the Nalu micro-Implantable Pulse Generator (mIPG) system, which consists of a fully-featured, battery-free, miniaturized IPG, which is powered by an externally worn Therapy Disc and controlled through a smartphone based remote control app. The Nalu Neurostimulation System is currently FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications.

On October 17 Boston Scientific announced it has entered into a definitive agreement to acquire Nalu Medical, Inc. for an upfront cash payment of approximately $533 million for the remaining equity not owned by Boston Scientific (which has been a strategic investor since 2017).

 

FDA approves Medtronic’s Altaviva™ tibial stimulator for urge urinary incontinence

Posted on by Posted in Incontinence, Medtronic, Tibial Nerve Stimulation
Altaviva tibial neuromodulation IPG

Image credit: Medtronic

On September 19, 2025, Medtronic announced that it had received FDA approval for its Altaviva implantable tibial nerve neurostimulator for the treatment of urge urinary incontinence (UUI).  The device is inserted near the ankle during a minimally invasive procedure that doesn’t require sedation or imaging, and is then activated to deliver therapy automatically.

The device is powered by a rechargeable battery based on Medtronic’s proprietary Overdrive™ battery technology with an expected longevity of 15 years.  According to Medtronic, the Altaviva IPG only needs to be recharged 1–2 times per year under standard therapy settings, with each session taking about 30 minutes when properly positioned.

Coloplast/Nine Continents Medical publishes pilot data on Intibia™ device for treatment of urgency urinary incontinence

Posted on by Posted in Coloplast, Incontinence, Nine Continents Medical, Tibial Nerve Stimulation
Intibia

From: https://doi.org/10.1016/j.neurom.2025.01.013

My colleague Nicolás Barabino of Adcorpus called my attention to a recent publication by Nine Continents Medical reporting on Coloplast’s Intibia™ System, which is an implantable tibial nerve stimulator in subjects with urgency urinary incontinence.

Nine Continents Medical was founded in Livermore, CA in 2014.  It was acquired in 2020 by ostomy company Coloplast acquired  for $145M upfront cash payment and an additional contingent future milestone payment.  The acquisition gave Coloplast an early-stage implantable tibial nerve stimulation treatment for over-active bladder.

The Intibia™ implantable tibial nerve stimulator (ITNS) is a miniaturized, self-powered unit placed in the lower leg under local anesthesia during a short, minimally invasive procedure.  It is claimed to have long battery life, with no need for patient compliance in therapy. Continue reading→

SetPoint Medical raises $140M to support commercialization of its rheumatoid arthritis therapy

Posted on by Posted in Rheumathoid Arthritis, SetPoint Medical, Vagus Nerve Stimulation

Image Credit: SetPoint Medical

On July 31, 2025, SetPoint Medical received FDA approval for its neuroimmune modulation device for the treatment of adults living with moderate-to-severe rheumatoid arthritis (RA) who are not adequately managed by—or cannot tolerate—existing advanced RA therapies, such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).

FDA’s approval was based on the results of the 242-patient randomized, double-blind, sham-controlled, RESET-RA study, that demonstrated the SetPoint System’s safety and efficacy in patients with moderately to severely active RA who had an incomplete response or intolerance to one or more biologic or targeted synthetic DMARDS.  The study met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics through 12 months of follow-up. 75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.

This week SetPoint announced that it raised $140M in private financing.  According to the press release, proceeds of the financing will support commercialization of the SetPoint System, as well as advancement of the company’s pipeline in other autoimmune conditions.

CorTec performs first human implant of its Brain Interchange System for stroke

Posted on by Posted in Brain Stimulation, Brain-Computer Interface, CorTec, Stroke
CorTec Brain Interchange Implant

Image Credit: CorTec

CorTec, a neurostimulation company based in Freiburg, Germany announced that it had performed the first human implant of its  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.

The implant, performed at the University of Washington School of Medicine, is intended evaluate the Brain Interchange Implant System as a novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity within the brain.

Salvia Bioelectronics recruits $60M Series B for its migraine therapy

Posted on by Posted in Migraine, Neural Stimulation, Salvia Bioelectronics
My Salvia Therapy for migraine and cluster headaches

Image Credit: Salvia Bioelectronics

Salvia Bioelectronics was founded in 2017 and is headquartered in Eindhoven, The Netherlands.  It is developing the MySalvia Therapy using an ultra-thin implant that comprehensively targets key nerves involved in migraine and cluster headache.

The neuromodulation therapy is delivered by two implants: one placed just beneath the skin of the forehead and another just beneath the scalp at the back of the head. Patients receive an external, wearable device that powers the implants to deliver therapy.

Last week, Salvia announced that it had recruited $60M to bring MySalvia Therapy to market.  According to the press release:

“BioElectronics, a clinical-stage medical device company pioneering neuromodulation therapy for people with chronic migraine, today announced the successful completion of a $60 million (€53 million) Series B financing round. The round was led by Innovation Industries, a European deeptech venture capital firm, with participation from Invest-NL and EIC Fund. Existing investors Inkef, Panakès Partners, SHS Capital, Dolby Family Ventures, BOM and Thuja Capital also joined the round. The funds enable Salvia to complete clinical development and prepare for the commercial launch of MySalvia Therapy, which is currently evaluated in the RECLAIM study, a multi-center, double-blind, sham-controlled study for people with chronic migraine. The funds also allow Salvia to focus on obtaining FDA market authorization in the US and regulatory approvals in Europe and Australia.”

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.

 

Medtronic and Boston Scientific Settle Axonics IP Dispute

Posted on by Posted in AIMD Business, Axonics, Incontinence, Sacral Root Stimulation

Image Credit: Axonix

Medtronic and Boston Scientific have reached a confidential settlement over the IP dispute between Medtronic and Axonics (now part of Boston Scientific). The settlement, which includes a payment from Boston Scientific to Medtronic resolves all outstanding litigation between Medtronic and Axonics.

 

 

Biotronik presents 24-month interim data from the BENEFIT-03 clinical study at NANS

Posted on by Posted in Biotronik, Pain, Spinal Cord Stimulation
Biotronik Prospera IPG

Image Credit: Biotronik

Biotronik received FDA approval for its Prospera™ Spinal Cord Stimulation System on March 31, 2023. The system is intended to treat chronic, intractable pain in the trunk or limbs.  The Prospera SCS System includes a rechargeable IPG, SCS leads, a clinician programmer, a patient programmer, and an external trial pulse generator.

This weekend at NANS 2025 Biotronik presented  24-month intermediate data from its BENEFIT-03 prospective, multicenter clinical study in Australia.  Continue reading→

Neuronoff’s Injectrode Transcutaneously-Powered Nerve Stimulation

Posted on by Posted in Neural Stimulation, Neuronoff, Pain, PNS, Spinal Cord Stimulation
Neuronoff Injectrode

Image Credit: Neuronoff

Some time ago, I posted about Bioness’ “StimRouter”, which is an externally-powered implantable peripheral nerve stimulator designed to reduce chronic pain. Unlike most externally-powered neurostimulators this device is not powered by RF received from the external transmitter. Instead, the external pulse transmitter is more like a TENS unit with gelled electrodes applied to the skin. The implant has no electronic components. It is just a lead that has a coil electrode that intercepts part of the current between the TENS electrodes, and routes the captured current to small electrodes in contact with the target nerve at the distal end of the lead.

A similar approach is now being trialed under an IDE by Cleveland-based Neuronoff, Inc.  Their “Injectrode” approach consists of an implanted lead that is injected via an 18 ga needle injection.  The lead is activated transcutaneously with an external stimulator. Continue reading→