David Prutchi – The World of Implantable Devices

NeuroXess Raises RMB 700 Million to Advance Implantable BCI Trials and Manufacturing

Posted on October 29, 2026 by David Prutchi Posted in AIMD Business, Brain-Computer Interface, NeuroXess, Paralysis, Spinal Cord Injury (SCI)

Image credit: The Chosun Daily

Shanghai-based NeuroXess announced a RMB 700 million (approximately US$105M) Series B financing on October 28, led jointly by SDIC Juli, Shenzhen Capital Group and Qinzhi Capital. The company plans to use the proceeds for multicenter registration trials of its fully implanted wireless brain-computer interface, regulatory submissions, manufacturing expansion and further product development. Its registration trial began at Huashan Hospital on July 7, with the latest announcement describing participation by nearly 20 hospitals.

The financing addresses the transition from experimental implants to reproducible clinical deployment and production. Entry into China’s innovative-device special review procedure, announced in July, is a regulatory development pathway rather than authorization for commercial sale.

LEAP-Block Trial Supports Left Bundle-Branch Area Pacing in Patients With AV Block

Posted on October 29, 2026 by David Prutchi Posted in Bradycardia, Cardiac Pacing, Heart Failure (CHF)

The LEAP-Block randomized trial, published in JAMA on October 28, compared left bundle-branch area pacing with conventional right ventricular pacing in patients with atrioventricular block, left ventricular ejection fraction of at least 50%, and an anticipated ventricular pacing burden above 40%. Investigators at 14 Chinese hospitals randomized 499 patients, with 482 included in the primary analysis. At 24 months, the Kaplan-Meier estimated incidence of death, heart failure events, or upgrade to biventricular pacing was 5.0% with left bundle-branch area pacing versus 13.2% with right ventricular pacing, corresponding to a hazard ratio of 0.37.

The difference was principally associated with fewer heart failure events. Death, pacing-induced cardiomyopathy, device complications, and upgrades to biventricular pacing did not differ significantly when examined separately. The results strengthen the clinical rationale for avoiding conventional ventricular activation patterns in patients expected to require frequent pacing.

MIT’s LUCID Implant Combines Ultrasound With Local Brain Infusion

Posted on October 27, 2026 by David Prutchi Posted in Cancer, Drug Delivery, MIT

MIT Lucid device for ultrasound-assisted drug delivery to brain

Image Credit: MIT

MIT researchers have developed LUCID, an experimental implant that places a 3D-printed infusion channel directly on an array of 24 miniature ultrasound transducers. A passive osmotic pump supplies fluid from an approximately 100 µL reservoir, while Bluetooth controls ultrasound delivery. The electronics include a wirelessly rechargeable battery. The design applies acoustic energy near the infusion outlet to increase the distribution of substances through surrounding brain tissue.

Tests in tissue phantoms and mice showed wider distribution with ultrasound than without it. The researchers envision eventual use after glioblastoma surgery.

Senseonics Begins Human Study of Direct-to-Phone Implantable Glucose Sensor

Posted on October 27, 2026 by David Prutchi Posted in Diabetes, Glucose Monitoring, Senseonics

Senseonics Freedom Implantable Glucose Sensor

Image Credit: Senseonics

Senseonics announced the start of a first-in-human study of Freedom, an investigational continuous glucose monitor designed to communicate directly with a smartphone. The system builds on the sensing technology used in Eversense 365, adding an implanted battery and Bluetooth electronics to eliminate the separate transmitter worn over the sensor. The development goal is one year of monitoring without an on-body component.

The early feasibility study will evaluate safety and device functionality, including communication through tissue. Senseonics reports that preclinical testing compared antenna configurations and implantation locations before selecting the human-study configuration. A pivotal study is planned for 2027, with a potential commercial launch targeted for 2028.

Paradromics and Siemens Healthineers Collaborate on Imaging for BCI Implantation

Posted on October 26, 2026 by David Prutchi Posted in ALS, Brain-Computer Interface, Paralysis, Parandromics

Image Credit: Parandromics

Paradromics and Siemens Healthineers announced a collaboration on October 19, 2026, to develop an integrated imaging workflow for implantable brain-computer interfaces. The planned approach combines structural and functional MRI, vascular imaging, and CT to support patient assessment, electrode targeting, surgical navigation, and localization of implanted components. Initial work will focus on speech-motor function, supporting Paradromics’ development of its investigational Connexus BCI for communication restoration.

A particularly interesting aspect is the proposed comparison of preoperative functional imaging with neural signals recorded directly by the implant. This could help researchers evaluate whether imaging identifies the most useful recording sites and refine targeting for subsequent patients. The collaboration addresses the practical challenge of making BCI implantation reproducible across clinical centers.

Mainstay Medical’s ReActiv8 study finds localized change in ultrasound-estimated muscle composition

Posted on October 26, 2026 by David Prutchi Posted in Mainstay Medical, Muscular Stimulation, Pain

Image Credit: Mainstay Medical

An exploratory Australian study published in the European Spine Journal examined whether Mainstay Medical’s ReActiv8 restorative neurostimulation changes lumbar multifidus muscle composition. Among 45 participants with complete measurements, ultrasound analysis found a lower estimated connective-tissue proportion at L3 after six months. Other examined levels showed no comparable change. ReActiv8 stimulates the medial branch of the L2 dorsal ramus to produce multifidus contractions.

The finding offers a possible mechanistic clue, but does not establish reversal of muscle fibrosis. The ultrasound method has not been validated against histology, and the study lacked a control group. Changes in the imaging measure were not linearly associated with improvements in pain, disability or quality of life.

Saluda initiates field action for certain Evoke closed-loop stimulators

Posted on October 26, 2026 by David Prutchi Posted in Uncategorized

Image credit: Saluda Medical

Saluda Medical has initiated a voluntary field action after a manufacturing-process change at a supplier was linked to unintended stimulation and charging failures in certain Evoke closed-loop spinal cord stimulators. According to Reuters’ October 21 report, the company identified approximately 3,900 potentially affected implanted devices and said the manufacturing process had been corrected. Affected unimplanted inventory is being removed and replaced.

Australia’s Therapeutic Goods Administration lists a Class II product alert covering Evoke CLS product code 1042 distributed from June 15, 2026. Its notice describes unintended stimulation during charging or impedance testing, and devices that cannot recharge. Battery depletion could interrupt therapy and ultimately require replacement. Saluda had received 26 complaints worldwide by October 6. The notice states that the company is not recommending preventive explantation or replacement of potentially affected implants.

Ceryx Manufactures Its First Implantable Respiration-Modulated Pacemaker

Posted on October 24, 2026 by David Prutchi Posted in Cardiac Pacing, Ceryx, Heart Failure (CHF)

Cysoni respiration-synchronized pacemaker

Image Credit: Ceryx Medical

Remember that weird dual-header device by Ceryx Medical that I reported about some time ago? Well, they now changed the image to something that looks more like a dual-chamber pacemaker’s demo unit.

Ceryx and King’s College London announced on October 22, 2026, that Ceryx’s first implantable pacemaker has been manufactured at the university’s MAISI facility. The investigational Cysoni system is designed to vary cardiac pacing with respiration, restoring the coupling between breathing and heart rhythm that the company is investigating as a treatment for heart failure. This is also the first implantable device produced by MAISI, which operates two ISO Class 7 cleanrooms under a certified quality management system.

The milestone advances the program from external pacing experiments toward an implantable implementation. Ceryx’s preceding RSA-Pace study used a temporary external pacing system, and full results remain pending. The newly manufactured implant now enters preclinical testing ahead of further clinical investigation.

EPFL’s LogSync neural chip decodes interactions between brain regions consuming200 µW

Posted on October 24, 2026 by David Prutchi Posted in Brain-Computer Interface, EEG Monitoring, EPFL

Image Credit: EPFL

EPFL (École Polytechnique Fédérale de Lausanne) researchers have developed LogSync, an approximately 4 × 2 mm neural system-on-chip intended for future adaptive neurostimulation systems. The chip extracts measures of oscillatory activity and synchronization between brain regions, then uses machine learning to classify cognitive or emotional states and generate stimulation triggers. According to EPFL’s October 23 announcement, the design consumes less than 200 µW, using logarithmic computation and joint hardware-algorithm development to reduce the processing demands of brain-network analysis. Evaluation combined previously collected human brain recordings with experiments in rats, where the system tracked oscillations and generated triggers at selected phases.

China’s Super Vision Technology i-NYS Extraocular Stimulator Activated in a Child With Congenital Nystagmus

Posted on October 24, 2026 by David Prutchi Posted in Nystagmus, Rectus Muscle Stimulation, Super Vision

Super Vision i-NYS implantable device for the treatment of Congenital Nystagmus

Image Credit: Super Vision

Super Vision Technology reported that a nine-year-old patient underwent activation and calibration of its i-NYS implant at Peking University People’s Hospital on October 21, 2026, following implantation on August 25. The system uses a pulse generator implanted behind the ear to deliver electrical stimulation to the lateral rectus muscle. It is intended to reduce involuntary eye movements and increase the time during which an image remains aligned with the fovea.

CorTec reports cortical-electrode recordings lasting more than four years

Posted on October 23, 2026 by David Prutchi Posted in Brain-Computer Interface, CorTec, EEG Monitoring

CorTec Closed-Loop Brain Interchange implant system

Image Credit: CorTec

CorTec announced that its micro-electrocorticography (µECoG) arrays have continued recording neural activity more than four years after implantation in a nonhuman primate at Weill Cornell Medicine. The research involved two animals, with 63 of 64 contacts still functioning in the animal under continued observation. Results presented at the September 2026 Graz Brain-Computer Interface Conference compared recordings through day 1,361 and found stable spatial and spectral characteristics, including distinguishable activity patterns during alert task performance and drowsiness.

The arrays sit on the dura without penetrating brain tissue and use medical-grade silicone and platinum-iridium, with materials and manufacturing methods shared by the electrodes in CorTec’s Brain Interchange system.

Medtronic Receives CE Mark for Pacemakers Designed for Conduction-System Pacing

Posted on October 23, 2026 by David Prutchi Posted in Bradycardia, Cardiac Pacing, Cardiac Stimulation (other), Heart Failure (CHF), Medtronic

Medtronic announced on October 19, 2026, that its Vitalis pacemaker portfolio has received CE marking. The family includes ReSyncra CSP, Restoria CSP, Refina CSP, Effectra, and Confirma, with dedicated conduction-system pacing features available in selected models. ReSyncra CSP provides an option for patients indicated for conventional biventricular pacing in whom effective cardiac resynchronization therapy cannot be achieved. Its AdaptivCSP algorithm automatically adjusts pacing timing to support ventricular synchronization.

The notable development is the integration of CSP-specific control and monitoring into the pulse generator. ReSyncra CSP, Restoria CSP, and Refina CSP incorporate CSP MVP programming options and a CSP Morphology Monitor for following therapy during remote and office evaluations. These capabilities complement Medtronic’s existing SelectSecure Model 3830 lead and CSP delivery tools, extending support beyond lead placement to ongoing therapy management.

Coherence Neuro Raises $45 Million to Advance Implantable Cancer Monitoring and Treatment

Posted on October 23, 2026 by David Prutchi Posted in Cancer, Coherence Neuro

Image Credit: Coherence Neuro

Coherence Neuro has announced $45 million in funding backed by Founders Fund and the OpenAI Startup Fund to develop implantable systems for monitoring and treating cancer. Its proposed SOMA-1 platform would combine recording of electrical activity in the tumor environment with responsive stimulation, initially targeting glioblastoma. The company reported preclinical work in mice using neural recordings to estimate tumor growth and plans to use the funding to advance toward its first chronic human glioblastoma trial. It is also seeking FDA Breakthrough Device designation and expanding its preclinical research into pancreatic cancer.

The engineering objective is to link continuous electrical sensing with therapeutic stimulation in a closed-loop implant. Coherence’s human study announced in June 2026 at Royal Melbourne Hospital represents an earlier development stage. That study uses CIPHER, a flexible thin-film cortical electrode system, for short-duration recording and stimulation during brain tumor surgery. It evaluates intraoperative safety, performance, and handling rather than chronic cancer treatment. Whether electrical measurements can reliably track human tumor progression and guide effective stimulation remains to be established. The devices remain investigational.

Nurotron auditory brainstem implant receives Chinese market approval

Posted on October 23, 2026 by David Prutchi Posted in Brainstem stimulation, Deafness, Nurotron

Nurotron brainstem stimulator for deafness

Image Credit: Nurotron

China’s National Medical Products Administration announced approval of Nurotron’s WH-01A auditory brainstem implant, developed with Professor Wu Hao’s team at Shanghai Ninth People’s Hospital. The implant addresses an important limitation of cochlear prostheses in patients with severe inner-ear malformations or an absent cochlear nerve may lack the anatomical pathway needed for cochlear stimulation to produce hearing. The WH-01A bypasses the cochlea and cochlear nerve, delivering electrical stimulation through an electrode array placed on the surface of the brainstem’s cochlear nucleus.

According to the developing team’s announcement, the system incorporates a 16-contact electrode array, a high-rate stimulation chip, and a coding strategy designed for Mandarin’s four lexical tones, with the ability to stimulate and record neural responses simultaneously. Registration trials began in 2022, with implantation and follow-up completed in 2024.

Our paper on the history of RF pacemakers was discussed on The Lead podcast live at HRX 2026

Posted on October 23, 2026 by David Prutchi Posted in Bradycardia, Cardiac Pacing, History, Museum, My Portfolio, Tech Talk, Wireless Power Transmission

Cuttler-Hammer RF pacemakers

We are honored that our paper, “The Forgotten History of Semi-Implanted Radiofrequency- and Inductive-Powered Cardiac Pacing Systems,” coauthored by Daniel Villamil and me and published in Pacing and Clinical Electrophysiology (PACE), was discussed on the Heart Rhythm Society’s The Lead podcast, recorded live at HRX 2026.
In Episode 174, Dr. Jason T. Jacobson hosts Dr. Michael S. Lloyd and Dr. Igor R. Efimov for an interesting discussion of these pioneering pacing technologies and their relevance to modern implantable devices. Many thanks to the panel and the Heart Rhythm Society for bringing attention to this often-overlooked chapter in the history of cardiac pacing.
Listen to the podcast free of charge:
Spotify: https://lnkd.in/gtJtXrTD
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Heart Rhythm Society (official episode page): https://lnkd.in/gBbbdPtd

Read our paper free of charge through Wiley’s read-only sharing service:
https://lnkd.in/g5iUEd3D

Author Archives: David Prutchi