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

Brain computer interface device IPSIHAND

Neurolutions IPSIHAND has been granted De Novo classification by the FDA. 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 US. The rehab process from 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 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 be used to 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 provides for seamless upload of 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 become the very first brain-computer interface device to be approved by FDA for treating stroke recovery in patients.

I am a technologist with years of experience with Apple and wearOS products and have a Bachelor’s degree in Computer Science. 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&fitness-tech evolution and keep 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 or Fossil Gen 5 LTE and keep a close eye on my HRV and other recovery metrics.

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