Healthcare organization Kandu Health combines forces with neurotechnology company Neurolutions, owned by BCI.
In early 2023, Neurolutions completed the first sales of its groundbreaking device, IpsiHand, marking a significant milestone in stroke rehabilitation. Now, operating as Kandu, the combined company aims to support patients from the immediate post-acute phase through chronic rehabilitation and recovery.
IpsiHand, a non-invasive brain-computer interface (BCI) device, has been making waves in the medical community. It consists of a headset, a tablet computer, and a hand brace, and it translates brain signals to enable stroke patients to open and close their hands. The Food and Drug Administration (FDA) authorized IpsiHand after all 40 patients in Neurolutions' 12-week trial demonstrated motor function improvements.
The device holds Breakthrough Device status, granted by the FDA since 2023, and received FDA 510(k) clearance for 30-day use in 2025. This regulatory authorization allows for marketing the device for limited duration use in stroke rehabilitation. However, there is no specific information confirming any Centers for Medicare and Medicaid Services (CMS) reimbursement status for IpsiHand or whether it is commercially available on a broad scale as of now.
The merged company, Kandu Health, has raised $30 million, with Ally Bridge Group and Amed Ventures co-leading the investment to fund Kandu's commercial strategy. This investment will support Kandu's efforts to provide ongoing support for stroke patients, aiming to lower the 28% of people who rate their quality of life as "poor or worse than death" one year after a stroke when treated under the current paradigm.
Kandu Health CEO Kirsten Carroll stated that IpsiHand is the first BCI technology cleared by the FDA for stroke rehabilitation and the first to receive a CMS reimbursement code. The Centers for Medicare and Medicaid Services created a procedure code and made a benefit category determination for IpsiHand in 2024.
The merger continues the integration of IpsiHand into Kandu Health's stroke support services. By providing ongoing support that evolves as people recover, Kandu Health aims to revolutionise stroke rehabilitation, offering patients access to Neurolutions' IpsiHand, a device cleared for use in the U.S.
It's important to note that while IpsiHand differs from BCI technologies in development at companies such as Synchron and Elon Musk's Neuralink because it noninvasively captures brain signals, the latest commercial availability or reimbursement details beyond what has been reported here can be found by checking Neurolutions’ official communications or FDA medical device databases directly.
[1] Regulatory authorization for IpsiHand: https://www.fda.gov/medical-devices/product-safety-information/safety-communications [2] CMS reimbursement status for IpsiHand: https://www.cms.gov/medicare-coverage-database/
- Kandu Health's groundbreaking device, IpsiHand, offers a significant leap in stroke rehabilitation, allowing patients to open and close their hands with the aid of a non-invasive brain-computer interface (BCI).
- The FDA authorized IpsiHand for marketing after a 12-week trial on 40 patients demonstrated motor function improvements.
- IpsiHand holds Breakthrough Device status, granted by the FDA, and received FDA 510(k) clearance for 30-day use in 2025.
- Kandu Health aims to lower the 28% of people who rate their quality of life as "poor or worse than death" one year after a stroke, using IpsiHand to provide ongoing support for stroke patients.
- Kandu Health CEO Kirsten Carroll announced that IpsiHand is the first BCI technology cleared by the FDA for stroke rehabilitation and the first to receive a CMS reimbursement code.
- The Centers for Medicare and Medicaid Services (CMS) created a procedure code and made a benefit category determination for IpsiHand in 2024.
- The latest commercial availability or reimbursement details for IpsiHand can be found on Neurolutions’ official communications or FDA medical device databases.
- Neurolutions' medtech innovation, IpsiHand, operates by translating brain signals captured via a headset, a tablet computer, and a hand brace.
- The investment raised by Kandu Health, co-led by Ally Bridge Group and Amed Ventures, will be utilized to fund the commercial strategy for IpsiHand.
- In the realm of health-and-wellness, medical-conditions, therapies-and-treatments, finance, and investing, the technology sector, particularly artificial-intelligence, holds immense potential for advancements in stroke rehabilitation through devices like IpsiHand.
