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

Author Archives: David Prutchi

Resonetics acquires MedAlly

Posted on by Posted in AIMD Business, Eagle Pitcher, Med-Ally, News, Resonetics
Resonetics implantable-grade battery

Image Credit: Resonetics

Resonetics was founded in 1987 as a provider of engineering and manufacturing solutions for the life sciences industry. Traditionally, they offered laser processing, centerless grinding, nitinol processing, thin-wall stainless steel & precious metal tubing, photochemical machining, microfluidics manufacturing, and sensor technology.

In 2022, they acquired EaglePicher’s medical battery division, expanding on the components that it can provide to the AIMD industry.

Yesterday, Resonetics announced that it has acquired the manufacturing assets, process know-how, and intellectual property related to implantable and external pulse generators (IPG/EPG) and leads manufacturing and assembly from Med-Ally, a medical technology design and development company focused on the neuromodulation market and based in Charleston, South Carolina.  This integration enables Resonetics to offer customers the development of complete AIMDs

As part of the deal, the acquired assets will ultimately be transferred to an existing Resonetics facility.

In Memoriam: Dr. Shmuel Yerushalmi ז״ל (1934–2025)

Posted on by Posted in Bradycardia, Cardiac Pacing, History, Mennen Medical (1976-1980), News, Omikron Scientific (1979-1985)

Dr. Shmuel Yerushalmi ז״ל (1934–2025)
Pacemaker Pioneer and Builder of Israel’s Biomedical Industry

I was deeply saddened to learn of the passing of Dr. Shmuel Yerushalmi ז״ל, a pacemaker pioneer whose work has been central to my research on the early history of implantable cardiac devices in Israel, and whom I had planned to visit during my current stay in the country.

Dr. Yerushalmi’s death marks the loss of one of the key figures in the formative period of Israel’s implantable medical device industry.  He was an engineer whose career bridged academic research, industrial development, and the practical challenges of bringing life-sustaining technology to patients. Continue reading→

History: Nuclear Pacemakers in Small-Town Pennsylvania: The Coratomic Story

Posted on by Posted in Biocontrol Technology, Bradycardia, Cardiac Pacing, Coratomic, Nuclear Batteries

Coratomic lithium pacemakers 1970s

Coratomic, Inc. was a cardiac device manufacturer based in Indiana, Pennsylvania. It was one of a handful of American firms that developed and marketed plutonium-238 radioisotope-powered pacemakers in the 1970s. Coratomic grew out of the Allegheny General Hospital nuclear-pacemaker program led by George J. Magovern, Sr., with David L. Purdy as the key technical founder and executive, and Nicholas P. D. Smyth as a principal clinical collaborator.

The initial enthusiasm for Pu-238 pacemakers waned as regulatory complexity, public concern about implanted nuclear material, and the improving longevity of lithium-chemistry cells converged. Like the other pacemaker companies of the time, Coratomic abandoned the development of radioisotope-powered devices and concentrated on lithium-powered pacemakers.

A few months ago, I was contacted by Tim Vore, a resident of Indiana, Pennsylvania, where Coratomic pacemakers were manufactured. He had found a few demo models at an estate sale, tucked inside an old, beaten-up desk in an attic. I acquired these from him (with his permission to tell the story of where he had found them).

Upon receiving them, I x-rayed the units and confirmed that they are all weighted mechanical dummies, except for one of the Ovalith units in which half of the shell had been cut open and the pacemaker’s internals were encapsulated to display their microcircuit (still using miniature, albeit discrete, components) and battery. The collection also included a few setscrew wrenches and hybrids encapsulated in dual-in-line metallic chip carriers.

In 1986, Coratomic changed its name to Biocontrol Technology, Inc., exited the pacemaker business, and focused increasingly on other medical technologies, notably a non-invasive glucose monitor.

A 2002 Pittsburgh Tribune-Review article states that “Bico, formerly known as Biocontrol Technology Inc., and before that, Coratomic Inc.” had accumulated large losses. Not surprisingly, in March 2003 Bico Inc. filed for Chapter 11 bankruptcy protection in federal court in Pittsburgh. As part of its court-approved reorganization, it later merged with cXc Services, Inc. – a small, privately held Delaware start-up created in 2003 to commercialize a “WebPhone” videophone product – marking a complete departure from its origins in implantable cardiac devices.

CMS issues favorable National Coverage Decision (NCD) for CCM® Therapy

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics
Impulse Dynamics OPTIMIZER Smart Mini IPG by Impulse Dynamics

Image Credit: Impulse Dynamics

Impulse Dynamics, the company where I serve as Executive VP and CTO announced that the Centers for Medicare and Medicaid Services issued yesterday a favorable National Coverage Decision (NCD) memo for Cardiac Contractility Modulation (CCM®) Therapy.  The decision was supported by the American College of Cardiology, the Heart Failure Society of America, and the Heart Rhythm Society.

According to the announcement:

“CCM® therapy for heart failure (HF) patients is one of only five therapies selected for the Transitional Coverage for Emerging Technologies (TCET) pathway in 2025. This determination marks a transformative milestone for HF patients and their providers, validating that CCM® therapy is no longer experimental or investigational.”

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.

Daré Bioscience

Posted on by Posted in Contraception, Daré Bioscience, Drug Delivery

Dare logo

MicroCHIPS implantable programmable pump for the treatment of osteoporosis

Image Credit: MicroCHIPS, Inc.

Daré Bioscience is a female-health-focused biotech company conducting end-to-end clinical development in ob-gyn.  They are developing the “DARE-LARC1” smart implant, a programmable drug delivery system for long-acting reversible contraception (LARC) and other long-term therapeutic uses like diabetes and obesity. This implant uses programmable micro-reservoirs to deliver precise doses for months to years from a single device, features wireless control with smartphone integration, can have its software updated remotely, and is powered by a battery designed to last up to 20 years. According to the company:

“DARE-LARC1 is a preclinical-stage investigational, long-acting reversible contraceptive (LARC) utilizing a next-generation programmable drug delivery device to administer levonorgestrel, the active pharmaceutical ingredient in a number of FDA-approved birth control methods, for an extended period without requiring day-to-day effort.”

Daré announced that it had received a $4.0 million non-dilutive funding installment under its multi-year grant agreement to support development of DARE-LARC1. This brings the total received to approximately $41.8 million of the up to approximately $49 million in committed grant funding for nonclinical development, IND-enabling studies, and preparation for submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).

 

Edwards acquires remaining 48% of Vectorius Medical

Posted on by Posted in Heart Failure (CHF), Sensors, Vectorius Medical

Image Credit: Vectorius Medical

Tel Aviv-based Vectorius Medical developed the V-LAP implantable device for the measurement of Left Atrial Filling Pressure (LAP). The device is implanted in the left atrium, has no battery, and is able to communicate with an external interrogator from deep within the body.

Edwards acquired a 52% stake in 2023.  Earlier this month Edwards acquired the remaining 48% stake at a valuation of $497 million. Vectorious will operate as a wholly owned subsidiary of Edwards.

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→

Nyxoah Receives FDA Approval for Genio® System for Treating Obstructive Sleep Apnea

Posted on by Posted in Muscular Stimulation, Nyxoah, Obstructive Sleep Apnea, Sleep Apnea
Nyxoah's miniature implant Genio implantable bilateral hypoglossal nerve stimulation for treatment of Obstructive Sleep Apnea

Nyxoah’s Genio implantable bilateral hypoglossal nerve stimulation for treatment of Obstructive Sleep Apnea
Image Credit: Nyxoah

I previously described efforts by Nyxoah, which was founded in 2009 by Robert Taub and Dr. Adi Mashiach in Mont-Saint-Guibert, Belgium, to develop neurostimulation treatments focused for Obstructive Sleep Apnea.

Last week (August 8, 2025), Nyxoah announced that FDA had approved its Genio System to treat a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

Nyxoah developed a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage during sleep. The implant is powered and controlled by a disposable external adhesive patch. Every evening the OSA sufferer uses a new disposable patch that carries an “Activation Chip” that is positioned every night by the patient under the chin. The Activation Chip has its own battery and has enough energy to wirelessly activate the implanted neurostimulator for a full night sleep session.

According to the press release:

“The Genio system’s FDA approval was supported by the high-quality, differentiated safety and efficacy data from the Company’s DREAM pivotal trial. The DREAM study met both its primary and secondary endpoints demonstrating an AHI responder rate of 63.5% and an Oxygen Desaturation Index responder rate of 71.3%, with an overall median AHI reduction of 70.8%. Additionally, 82.0% of all DREAM subjects saw their AHI scores drop below 15 or lower.

Importantly, the DREAM study demonstrated that Genio is efficacious regardless of a patient’s sleeping position and, to our knowledge the only therapy with such clinical evidence in a large, multicenter, prospective clinical study using data from a full night polysomnography. This is a critical differentiator as on average, people sleep in a supine position between 35% and 40% of the night. The DREAM study measured position-specific outcomes and demonstrated a 66.6% median AHI reduction while patients slept in a supine position despite the fact that the number of airway obstructions can double in this position. This reduction compares favorably to the 71.0% reduction in AHI shown while patients slept in a non-supine position.”

BerlinHeals publishes results on from the C-MIC II trial of microcurrent therapy for heart failure

Posted on by Posted in Berlin Heals, Cardiac Stimulation (other), Heart Failure (CHF), Microcurrent
Berlin Heals C-MIC

C-MIC Device. Image Credit: Berlin Heals

Berlin Heals recently published results of its open-label randomized controlled trial of its C-MIC device.  The study enrolled 70 ambulatory patients (32 C-MIC, 33 control) with non-ischaemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 25%to 35% and New York Heart Association (NYHA) class III–IV.

According to the June 2025 abstract:

“At 6 months, treatment with C-MIC versus control improved LVEF (mean difference: 5.1%; 95% confidence interval [CI] 3.1–7.1%, p < 0.001). The proportions of patients with improvement in at least one NYHA class (risk difference: 68.9%; 95% CI 50.6–87.2, p < 0.001), an increase of ≥5 points in KCCQ-OSS (risk difference: 60.0%; 95% CI 42.3–77.6, p < 0.001), and an increase of ≥30%in 6MWD (risk difference: 38.3%; 95% CI 14.4–62.2) were substantially higher in the device versus control group(p < 0.002).”

In June, Berlin Heals also reported on the 2-year follow-up of patients from the initial C-MIC pilot study who were alive at 6 month as follows:

“Of the 10 patients enrolled in the initial study, 7 were enrolled in follow-up (mean age 52.4 ± 7.6 years, NYHA Class III and mean LVEF 31.7 ± 3.7%). No device-related adverse events occurred. One non-cardiac, non-device related death was reported at 18 months. Improvement in LVEF of 11.60% [95% confidence interval (CI): 5.64–17.56, P < 0.001] from baseline to 6 months was maintained at 2 years post-C-MIC deactivation, with a sustained increase of 12.56% from baseline (95% CI: 4.67–20.45, P = 0.002). Similarly, the 6 min walk distance improved by 206.35 m at 6 months (95% CI: 161.32–251.39, P < 0.0001) and remained at 191 m above baseline at 2 years (95% CI: 131.83–250.99, P < 0.0001). Improvements in NYHA functional class and SF-36 quality-of-life scores observed at 6 months were also preserved throughout the 2 year follow-up. One patient required C-MIC reactivation.”

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.

UNEEG Medical’s long-term EEG monitor for epilepsy management

Posted on by Posted in EEG Monitoring, Epilepsy, UNEEG Medical
UNEEG device

Image Credit: UNEEG Medical

UNEEG Medical, headquarters in Allerød, Denmark has developed a subcutaneous electroencephalography system (sqEEG), which is implanted under the scalp behind the ear. The implant acquires EEG signals fro a lead placed in the brain region where seizures are expected to occur.  EEG data is then transmitted to an interface placed behind the ear, and downloaded into the patient’s smartphone.

UNEEG reported on a study of ten adults with treatment-resistant epilepsy who wore the device for up to 15 months, collecting over 72,000 hours of brainwave data and detecting 754 seizures. Participants also kept seizure diaries and used fitness trackers to log their health.  A comparison of the patient’s reports and the implant data showed that patients had only correctly recorded about 48% of their actual seizures. In contrast, 27% of the episodes logged in the diaries didn’t show any seizure activity at all.

Additionally, the study showed that the device was able to distinguish between convulsive, nonconvulsive with awareness, and nonconvulsive without awareness seizures.  The-device based classification was more accurate that through self-reporting.  Lastly, most users found the implant unobtrusive and acceptable, with many wearing it for more than 20 hours a day.

UNEEG received the CE mark and launched its EpiSight in September 2024.  In June 2025, UNEEG received EU approval for 3-year continuous use of its subcutaneous implant.

Epiminder’s Minder System for continuous EEG monitoring for management of epilepsy

Posted on by Posted in EEG Monitoring, Epilepsy, Epiminder
Epiminder system

Image Credit: Epiminder

Australian-based Epiminder has been developing a continuous EEG monitoring (iCEM™) system intended to be uses in the management of drug-resistant epilepsy.

The system consists of an EEG recording and transmitting device implanted under the scalp which wirelessly sends the brain activity data through the skin to the Minder Wearable. The rechargeable Minder Wearable receives and stores EEG recordings and then transfers them to a smartphone-based Minder App, which uploads them to the Minder Cloud, from which they can be retrieved and reviewed by healthcare providers.

In April 2025 Epiminder announced that it received FDA de-novo authorization for its iCEM system.  In June 2025 Epiminder published results from its landmark UMPIRE trial, which validated the safety and efficacy of the Minder iCEM system. The study, conducted across Australia, demonstrated Minder’s ability to capture high-quality EEG data for extended periods, with signal quality equivalent to 10-20 scalp EEG.

 

GLP-1 drugs competing with implantable devices

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

Image Credit: Inspire Medical

This week Inspire’s shares dropped by 32% after it cut its full-year sales outlook by $42.5M below the outlook Inspire issued three months ago.  Inspire also expected income to be in the range of 40 to 50 cents a share, well below its previous guidance for $2.20 to $2.30 per share.

Inspire blamed the slower-than-expected rollout of Inspire’s new Inspire V system and the disclosure that patients may be delaying implant of the Inspire device as they first try GLP-1 weight-loss drugs, some of which are now approved by FDA to treat obstructive sleep apnea.

Obesity is a cause of a number of diseases that are now treated with implantable medical devices. It is no surprise that GLP-1 drugs, which have gained enormous popularity for their effectiveness in weight loss, would be seen by patients and medical providers alike as a first alternative to using invasive devices.

I believe that this trend will impact the AIMD industry as GLP-1 drugs (which are not without major downsides) take precedence ahead of implantable devices in the treatment of hypertension, cardiovascular diseases, neurological diseases, and autoimmune diseases.