Brain computer interface device from Neurolutions gets De Novo classification from FDA

Brain computer interface device IPSIHAND

The FDA has granted Neurolutions IPSIHAND De Novo classification. This novel brain-computer interface device can be used for post-stroke rehabilitation.

This is the first FDA-approved device leveraging brain-computer interface technology to assist chronic stroke patients in rehabilitation. The device utilizes the uninjured, or ipsilateral, side of the brain to improve arm and hand function.

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The IpsiHand offers the potential to regain the ability to perform the basic upper extremity tasks essential to daily life. 

Nearly 300,000 people suffer from stroke every year in the US. The rehab process from a stroke can be difficult for many.

Stroke typically causes paralysis on one side of the body, leaving patients nearly or completely unable to move some of their limbs. These patients can gain voluntary movements after years of therapy, but the IpSihand device can accelerate this process of recovery.

The technology was initially created in 2017 by a team of scientists at the Washington University School of Medicine, St. Louis. 

Brain-computer interface technology can assist patients in chronic stroke rehabilitation by leveraging the patient’s uninjured side of the brain to open and close the robotic exoskeleton.

The Neurolutions platform consists of a wireless EEG electrode device worn on the head that is used to measure the patient’s brain signals; these signals are analyzed by the system to determine the patient’s intent to move their affected hand and translates the signals into motor movement of the robotic skeleton, resulting in opening and closing of the impaired hand.

The accompanying tablet is the interface to the IpsiHand therapy and communicates with the overall system, including the biometric headset and the wearable robotic exoskeleton. 

An application running on the tablet guides the patient through the therapy session and seamlessly uploads usage and performance data to the cloud.

The space for Brain-Computer interface devices is picking up traction.

Elon Musk’s Neuralink company has also been doing some interesting work in this area. Last year, Neuralink said that the US Food and Drug Administration gave its device a “Breakthrough Device” designation in July, meaning the process for getting it reviewed and approved can be expedited.

But for now, the IPSIHAND device from Nuerolutions has become the first brain-computer interface device to be approved by the FDA to treat stroke recovery in patients.

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Sudz Niel Kar
I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. In my day job, I advise Fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health and fitness-tech evolution and keeping a close eye on patents, FDA approvals, strategic partnerships, and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


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