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

Category Archives: AIMD Companies

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.

Impulse Dynamics®’ INTEGRA-D Trial Completes Efficacy Phase for CCM-D System

Posted on by Posted in Bradycardia, Cardiac Contractility Modulation, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Impulse Dynamics, My Portfolio, Tachycardia
Impulse Dynamics OPTIMIZER Integra CCM-D IPG

Image credit: Impulse Dynamics Note: The OPTIMIZER Integra CCM-D System is an investigational device. It is not available for sale in the United States.

Yesterday, Dr. Niraj Varma, on behalf of the INTEGRA-D investigators, presented data for the efficacy phase of the clinical trial of the combined Cardiac Contractility Modulation/Defibrillator System (OPTIMIZER Integra CCM-D). The results were presented at a late-breaking clinical trial session at the 2025 Heart Rhythm conference in San Diego, CA.

This is a very important step for Impulse Dynamics – the company for which I serve as CTO and Executive VP – towards bringing to market a single device which combines our proprietary CCM therapy for the treatment of HF symptoms with implantable cardioverter defibrillator (ICD) therapy.

In the trial, the OPTIMIZER Integra CCM-D device successfully converted 100% of ventricular fibrillation (VF) induced in 100 consecutive patients, meeting the primary efficacy endpoint.  The Company’s press release is available here.

Note: The OPTIMIZER Integra CCM-D System is an investigational device. It is not available for sale in the United States.

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.

CorTec and Heraeus Medevio establish alliance to produce nerve cuff and paddle electrodes

Posted on by Posted in CorTec, Muscular Stimulation
CorTec Nerve Cuff and Paddle electrodes

Image Credit: CorTec

CorTec GmbH announced that it had entered into a strategic partnership with Heraeus Medevio, based in Minneapolis, USA.  The venture aims to support customers in the neuromodulation sector, from concept and small series production (CorTec) to large series production (Medevio) of nerve cuff and paddle electrodes.

According to the announcement, Medevio is expected to begin high-volume manufacturing of nerve cuff and paddle electrodes based on CorTec’s proprietary laser-micromachining technology by the end of 2025.

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.

 

 

DOJ Investigating Inspire Medical for Medicare/Medicaid False Claims

Posted on by Posted in AIMD Business, Inspire Medical, Sleep Apnea

Image Credit: Inspire Medical

Inspire Medical disclosed that it is being investigated by the Department of Justice for allegations of false Medicare and Medicaid reimbursement claims.

Their latest SEC 10k filing explains:

“On January 17, 2025, we received a civil investigative demand (“CID”) from the Department of Justice U.S. Attorney’s Office for the District of Minnesota pursuant to the False Claims Act in the course of the government’s investigation concerning allegations of false claims, including false claims arising from violations of the Anti-Kickback Statute, submitted to government payors in connection with our implant. The CID requests information relating to the marketing, promotion and reimbursement practices associated with our products. We are cooperating with the investigation”

 

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→

History: Mennen Medical and the First Israeli Pacemakers 1976-1980

Posted on by Posted in Bradycardia, Cardiac Pacing, Greatbatch Medical (Power), History, Mennen Medical (1976-1980), Museum, Omikron Scientific (1979-1985)
Mennen Medical’s Model 801 pacemaker. From: https://www.makash.org.il/sy/jerusa_book.pdf

Mennen Medical’s Model 801 pacemaker. From: Dr. Shmuel Yerushalmi’s memoir at www.makash.org.il/sy/jerusa_book.pdf

I spent the year-end holidays in Israel and had the pleasure of speaking with some of Mennen Medical’s and Omikron Scientific’s first employees regarding the efforts that these companies made in the late 1970s and early 1980s towards the development and manufacture of pacemakers in Israel.

Benny Kiron, who joined Mennen Medical in 1976 as a product designer, referred me to Dr. Shmuel Yerushalmi’s memoir at www.makash.org.il/sy/jerusa_book.pdf, from which I was finally able to understand the origin of Mennen Medical’s pacemaker project, as well as its relationship with Omikron Scientific.

Dr. Shmuel Yerushalmi was born in Brasil and emigrated to Israel in 1956. In 1976, while still pursuing his doctorate at the prestigious Weizmann Institute, he started working at the Israeli subsidiary of Mennen-Greatbatch of Clarence, NY.

The Mennen-Greatbatch partnership was dissolved when Wilson Greatbatch decided to concentrate on lithium battery development, and the Israeli company became a subsidiary of Mennen Medical, where an implantable pacemaker project was started.

RF-powered pacemaker developed by the Weizmann Institute and meant for production by Elta. From: https://www.makash.org.il/sy/jerusa_book.pdf

RF-powered pacemaker developed by the Weizmann Institute and meant for production by Elta. From: Dr. Shmuel Yerushalmi’s memoir at www.makash.org.il/sy/jerusa_book.pdf

Shmuel Yerushalmi had worked on the development of an RF-powered pacemaker while still a technician at the Weizmann institute, so his experience was tapped at Mennen Medical to lead the development of a VVI pacemaker powered by a Greatbatch lithium battery. The project was supported by Israel’s Chief Scientist Office and the BIRD (Israel-US Binational Industrial Research and Development) Foundation .

PCBA of Mennen Medical’s Model 801 pacemaker. Device was kindly gifted to me by Koby Kamin. ©2025 David Prutchi.

PCBA of Mennen Medical’s Model 801 pacemaker. Device was kindly gifted to me by Koby Kamin. ©2025 David Prutchi.

Continue reading→

Glucotrack starts study enrollment of implantable CGBM

Posted on by Posted in Diabetes, Glucose Monitoring, Glucotrack
Glucotrack's implantable continuous glucose monitor

Image Credit: Glucotrack

Glucotrack announced that it has started enrolling a feasibility study for its implantable continuous blood glucose monitoring (CBGM) device.  The study will include participants with both type 1 and type 2 diabetes, with data from the study expected to be available within 6-8 weeks.

According to the company, “unlike traditional continuous glucose monitors that measure glucose levels in interstitial fluid, Glucotrack’s CBGM measures glucose directly from blood, aiming to provide real-time readings without the lag time typically associated with interstitial glucose measurements. The CBGM is a long-term implantable device with no on-body external component, designed for three years of continuous, accurate blood glucose monitoring, offering a more convenient and less intrusive glucose monitoring solution.”

Continue reading→

Paxos Medical developing neurostimulator for on-demand bladder voiding

Posted on by Posted in BladderVoiding, Paxos Medical
Paxos Medical is developing an implantable neuromodulation system that allows on demand bladder voiding without the use of 4-6 daily self-catheterizations for underactive bladder patients.

Image Credit: Paxos Medical, captured from Paxos Medical’s Lightning Pitch

Paxos Medical was founded in 2022 by Matthew Fraser, PhD and Jeff Erb in Marple Trail, Minnesota.  The company is developing an implantable neuromodulation system that allows on-demand bladder voiding, and is intended to replace the need for 4-6 daily self-catheterizations for underactive bladder patients.

Detailed information is still scarce, but the PCT publication of their patent application indicates that the idea is to stimulate the nerves of the proximal urethra to initiate and sustain urination.  Paxos has mentioned that 60 seconds of stimulation to pro-voiding nerve bundles can drive a void to completion.

 

 

Interesting Paper on Dorsal Root Ganglion Stimulation to Increase Diuresis

Posted on by Posted in Diuresis, Heart Failure (CHF), Medtronic
From Pawel et al., "Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis,"Neuromodulation: Technology at the Neural Interface, Volume 27, Issue 7, 2024, Pages 1208-1217

From Pawel et al., “Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis,”
Neuromodulation: Technology at the Neural Interface, Volume 27, Issue 7, 2024, Pages 1208-1217

Scientists from Medtronic’s Bakken Research Center in The Netherlands, along with collaborators from Poland just published a paper on increasing diuresis through Dorsal Root Ganglion (DRG) stimulation as a potential therapy for heart failure.

The paper “Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis” was published in Neuromodulation: Technology at the Neural Interface (Volume 27, Issue 7, 2024, Pages 1208-1217).  A summary abstract is available from Elsevier.  It explains:

“Stimulation of diuresis is an essential component of heart failure treatment to reduce fluid overload. Over time, increasing doses of loop diuretics are required to achieve adequate urine output, and approximately 30% to 45% of patients develop diuretic resistance. We investigated the feasibility of affecting renal afferent sensory nerves by dorsal root ganglion neurostimulation as an alternative to medication to increase diuresis.”

The study was conducted in 7 pigs and showed that electrical stimulation (bDRG) at T11 and/or T12 caused an average diuresis increased 20% to 205% compared with no stimulation.   The authors report that side effects such as motor stimulation were mitigated by decreasing current or terminated spontaneously without intervention, and that there was no negative effect on acute kidney function because blood electrolyte concentrations remained stable.

Affluent Medical’s Artus Artificial Sphincter for Urinary Incontinence

Posted on by Posted in Affluent Medical, Artificial Sphincter, Incontinence, MPS Micro Precision Systems, Myopowers
Affluent Medical's Artus artificial sphincter for urinary incontinence

Image credit: Affluent Medical

Walking down MD&M Minneapolis’ aisles, I saw an implantable device that I hadn’t seen before. It is an artificial mechanical sphincter being developed by Affluent Medical based in Aix-en-Provence, France.  The device is aimed at treating stress urinary incontinence, which is a disabling condition that results in uncontrolled urinary leakage during effort such as coughing or sport.

Continue reading→