# AlphaDBS (αDBS) by Newronika

Canonical page: https://technooptimist.io/neurotech/alphadbs
Frontier: [Neurotech](https://technooptimist.io/neurotech.md) · Field: Brain stimulation implants · Company: [Newronika](https://technooptimist.io/companies/newronika.md)
Stage: Deploy (4 of 5: Research → Proto → Pilot → Deploy → Scaling)
Updated: last update 2026-09-30, facts checked 2026-10-11
Goal: Make adaptive deep brain stimulation the standard for Parkinson's: stimulation that tracks the brain's changing state through the day, so patients get more symptom-free time and fewer side effects than fixed settings give.
Status: CE marked and sold in Europe; ADVENT US/EU pivotal trial implanted its first patient Sept 2026
Next milestone: Enrol 104 patients at up to 18 US and EU sites

## Milestones

| Status | Milestone | Date | Slip |
| --- | --- | --- | --- |
| Done | FDA IDE for a pivotal US trial | 2025 |   |
| Done | CE mark for AlphaDBS | 24 Mar 2025 |   |
| Done | CE mark for release with WebBioBank cloud link | 14 Jul 2026 |   |
| Done | First ADVENT participant implanted (Monza) | 21 Sep 2026 |   |
| Current | Enrol 104 patients at up to 18 US and EU sites |   |   |
| Planned | US premarket approval application |   |   |

## Most important updates

- **30 Sep 2026**: First participant implanted in Newronika's ADVENT pivotal trial of adaptive versus conventional DBS. The first ADVENT participant received the αDBS implant on 21 September 2026 at San Gerardo dei Tintori hospital in Monza, Italy. ([our story](https://technooptimist.io/stories/first-participant-implanted-in-newronika-s-advent-pivotal-trial-of-838f02cd.md) · [original source](https://www.webdisclosure.com/press-release/newronika-announces-first-participant-implanted-in-advent-pivotal-study-ruTYFzwkAYW))
- **14 Jul 2026**: Newronika gets CE mark for new αDBS release integrated with its WebBioBank neural data cloud. The latest commercial version of αDBS is CE marked with full links to WebBioBank, the company's cloud platform for neural data. ([our story](https://technooptimist.io/stories/newronika-gets-ce-mark-for-new-dbs-release-integrated-with-its-c7d7dbab.md) · [original source](https://www.medicaldevice-developments.com/news/newronikas-adbs-system-secures-ce-mark-with-cloud-data-integration/))
- **24 Mar 2025**: Newronika wins CE mark for AlphaDBS adaptive deep brain stimulation for Parkinson's. Newronika's AlphaDBS, a closed-loop system that adjusts stimulation from real-time brain signals, received the CE mark. ([our story](https://technooptimist.io/stories/newronika-wins-ce-mark-for-alphadbs-adaptive-deep-brain-stimulation-for-e8a45123.md) · [original source](https://www.prnewswire.co.uk/news-releases/newronika-receives-ce-mark-approval-for-alphadbs-advancing-adaptive-deep-brain-stimulation-for-parkinsons-disease-302408082.html))

## Current obstacles

- **Not yet approved in the US**: The device is investigational in the US; approval depends on ADVENT, which compares adaptive and conventional modes blind in 104 patients.
- **Competing with Medtronic**: Medtronic already sells adaptive DBS approved in Europe and the US, so Newronika must win on results or ease of use.

## Physics limits

- **A noisy, indirect symptom marker**: Local field potentials are the blurred sum of thousands of neurons and are also shifted by movement, sleep and medication, so mapping them to how a patient feels is imperfect.
- **Stimulation drowns out the signal**: The electrodes must record microvolt brain rhythms while delivering volt-scale pulses nearby, so sensing has to reject huge stimulation artefacts.

## How it works

### Leads: Electrodes deep in the brain

As in standard DBS, electrodes sit in the subthalamic nucleus, a motor control hub, and deliver electrical pulses that calm Parkinson's symptoms.

### Listening: Reads local field potentials

The same electrodes record local field potentials, the summed electrical rhythm of nearby neurons, which change as symptoms rise and fall.

### Adjusting: Keeps stimulation in a target window

A stimulation engine compares the signal with patient-specific settings and raises or lowers stimulation automatically to stay in the window.

## Spec sheet

| Spec | AlphaDBS (αDBS) | Provenance |
| --- | --- | --- |
| Sensed signal | Local field potentials | reported |
| System | Implanted generator, clinician interface, patient remote | reported |
| ADVENT enrolment | 104 patients | reported |
| ADVENT sites | Up to 18 (US and EU) | reported |
| EU indication | Levodopa-responsive Parkinson's, adjunct | reported |

Provenance: reported = stated by the company; estimated = our estimate; sample = a sample figure.

## About Newronika

Newronika is a Milan medtech company spun out of the Policlinico hospital and the University of Milan. Its αDBS implant reads brain signals and adjusts deep brain stimulation for Parkinson's on its own, minute by minute.

- AlphaDBS won its CE mark in March 2025; a new release linked to the WebBioBank cloud got CE mark in July 2026.
- First patient implanted in the ADVENT pivotal trial on 21 September 2026 in Monza, Italy.
- ADVENT (104 patients, up to 18 US and EU sites) runs under an FDA IDE and is meant to support US approval.

- Headquarters: IT
- Status: private
- People: Lorenzo Rossi (Co-Founder, CEO and CTO)
- Partners, customers, investors: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (partner); Fondazione IRCCS San Gerardo dei Tintori (partner)

Company page: https://technooptimist.io/companies/newronika.md

## Related programs

Everything in Neurotech: https://technooptimist.io/neurotech.md

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