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The BCI Briefing

Company profileCore BCI

Kandu

Maker of IpsiHand, a non-invasive BCI for hand rehabilitation after stroke that the FDA authorised for marketing in 2021, years before any implanted system.

Location
United States
Founded
2007
Also known as
Kandu, Inc. · Kandu Health · IpsiHand · formerly Neurolutions
Sources last checked
5 Oct 2026

What they are building

Formed in 2025 by the merger of Neurolutions and the stroke-care company Kandu Health. IpsiHand reads movement intention with a non-invasive EEG headset, from the hemisphere the stroke did not damage, and opens and closes a powered brace worn on the affected hand.

Interface category
Electroencephalography
Signal
Summed field potentials, blurred and attenuated by skull and scalp
Invasiveness
Non-invasive
Recording / stimulation
Recording
Device
IpsiHand — EEG headset, tablet and a powered brace on the hand and wrist that opens and closes on decoded movement intention
Regulatory status
FDA De Novo marketing authorisation (2021), by prescription
Main use cases
Restore, Move

Where they are clinically

Approved / cleared

Authorised by a regulator for a defined use. Always check the scope.

IpsiHand received FDA De Novo marketing authorisation in 2021 for upper-extremity rehabilitation in chronic stroke. It is a non-invasive, prescription device, not an implant. The founding year is that of Neurolutions.

Access today

Available

Authorised and obtainable for a defined group of patients or users.

Shown in people
FDA De Novo authorisation in 2021, and a completed at-home study with 109 participants.
Still an aim
Reimbursed home therapy at scale, through a Medicare billing code and a telehealth service.
What stands in the way
Adoption: whether clinicians prescribe it and payers cover it.

On record here: 0 peer-reviewed papers

  • Apr 2021US FDA — De Novo marketing authorisation. A non-invasive EEG system for upper-extremity rehabilitation in chronic stroke, by prescription. Granted to Neurolutions, now part of Kandu.

Why this company matters

IpsiHand answers a question that implant coverage tends to skip: which BCI did a regulator authorise first? As far as we can establish it was this one, in 2021, non-invasive and for rehabilitation, five years before the first implanted system was registered in China. Washington University, where the technology was developed, calls it the first FDA-authorised BCI for rehabilitation. The device does not restore a lost channel of communication. It uses the BCI as a training signal, on the theory that pairing the intention to move with the movement helps the brain relearn it. The merger with a telehealth company and a Medicare billing code are a test of whether a BCI therapy can be delivered and paid for at home, which every later product will have to pass too.

Key milestones

  1. 12 Sep 2025

    A study of fully remote, at-home use of IpsiHand reaches primary completion with 109 participants.

    ClinicalTrials.gov

  2. 8 Apr 2025

    Neurolutions and Kandu Health merge to form Kandu, with the first close of a $30M financing co-led by Ally Bridge Group and AMED Ventures.

    Healthcare Dive

  3. Apr 2021

    FDA grants De Novo marketing authorisation for the IpsiHand Upper Extremity Rehabilitation System.

    IpsiHand authorised through De Novo

  4. 2007

    Neurolutions is founded by Eric Leuthardt and Daniel Moran to commercialise BCI research at Washington University in St. Louis.

    Washington University School of Medicine in St. Louis

Funding history

  • 8 Apr 2025$30MFinancing with merger · led by Ally Bridge Group, AMED VenturesAnnounced with the merger of Neurolutions and Kandu Health as the first close of a $30M round.

Investors namedAlly Bridge Group · AMED Ventures

Rounds in the Briefing’s sample only; not a complete funding history.

Leadership

  • Kirsten Carroll

    Chief executive of Kandu Health at the merger

As publicly stated by the organisation. Not a complete list.

IP and patents

Filings touch 5 of the 11 layers, most often interface and electrodes (8 of 13 families) and decoding (5).

13
patent families identified and counted as BCI
2013
earliest first filing among them
8
first filed since 2021; the latest years are incomplete
6 of 13
include a granted member, of those whose family record was read

Across the stack: families by layer

Themes, by number of families: electrodes and arrays (6), peripheral interfaces (4), motor decoding (3), signal processing (2), neural decoding (2), stimulation (2). A family can carry several.

Published in: United States (13), Australia (5), Canada (5), China (5), Japan (1), counted over the 13 families whose full record was read.

7 more families counted

Families found for Kandu in the EPO’s worldwide database, grouped so that one invention counts once. A filing shows what a company sought to protect. It does not show that the technology was built, is in a product, or works in people, and themes are read from titles, abstracts and classes, not from the claims. How to read this

Competitive context

Sources

  1. 01

    Stroke-recovery device using brain-computer interface receives FDA market authorization (opens in a new tab)

    Company reportedWashington University School of Medicine in St. Louis27 Apr 2021Checked against source 5 Oct 2026

    Published by the university that developed and licensed the technology, so we treat it as the developers' own account. States the De Novo authorisation, the founding of Neurolutions in 2007 and its founders, and calls the device the first FDA-authorised brain-computer interface for rehabilitation.

  2. 02

    Kandu Health merges with BCI company Neurolutions (opens in a new tab)

    Independent reportingHealthcare Dive9 Apr 2025Checked against source 5 Oct 2026

    Reports the merger, the $30 million financing and its co-leads, the 2021 De Novo authorisation and the Medicare procedure code created in 2024. Does not give the merged company's headquarters.

  3. 03

    ClinicalTrials.gov NCT05965713: Fully remote use of the IpsiHand device in hemiparetic stroke (opens in a new tab)

    Clinical registryClinicalTrials.govChecked against source 5 Oct 2026

    Sponsor Neurolutions, Inc. Completed with 109 participants; primary completion 12 September 2025.