DEPLOYDatabase

Company

NeuroLutions

NeuroLutions (now merged into Kandu, Inc.) developed the IpsiHand System, the first FDA-cleared brain-computer interface device for stroke rehabilitation.

Founded
2007
HQ
St. Louis, Missouri, USA
Status
private

The verified answer

As of Sep 2026, DEPLOY verifies NeuroLutions: 1 model, 2 deployments across 2 regions. 1 source back the record.

CategoryBiometric wearables

Overview

NeuroLutions (now merged into Kandu, Inc.) developed the IpsiHand System, the first FDA-cleared brain-computer interface device for stroke rehabilitation. The wearable BCI translates brain signals from the uninjured hemisphere into hand movement. In 2024, CMS created a dedicated Medicare reimbursement code — the first for any BCI device. Merged with Kandu Health in 2025 with 0M financing.

Verified record

Verified deployments
2 deployments on file
Active incidents
None on file

Key facts

FDA

First FDA-cleared BCI for stroke rehab

Product

Type

Non-invasive BCI

Parent

Kandu Inc.

Data & sources

Web sources

1

1 source backing this record.View all →

Current leadership (2)

Founders (1)

See all founders across the registry →

Safety record

No incidents on record for NeuroLutions.

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Full safety record: incidents, sourcing, and exposure data →

Operator customers (1)

Recent coverage

NeuroLutions in third-party press

Peer companies