FDA approves 1st-in-human trial for neural-enabled prosthetic hand

The FDA granted an investigational device exemption for the 1st-in-human trial of a neural-enabled prosthetic hand developed at Florida International University, backed by more than $2 million from the U.S. Defense Dept.

The device is designed to stimulate nerves in the arm to provide sensation during use. It’s billed as the 1st fully implantable, wirelessly controlled Class-III device with electrodes that can be surgically implanted within the nerves of the residual arm.

The Haptix program at the Pentagon’s Defense Advanced Research Projects Agency is backing the 1st-in-human trial with the $2.2 million grant.

“The system is intended to restore the sense of touch, and hand opening which would allow users to precisely differentiate the size and fragility of various objects,” Ranu Jung, who led the Adaptive Neural Systems Laboratory team that developed the device, said in prepared remarks. “The prostheses that exist today make it difficult for amputees to manipulate delicate and small objects because they can’t feel them.

“The system reflects an almost decade-long collaborative team effort. For the 1st time, amputees will be able to use a fully implantable, sensory enabled prosthetic hand system at home for daily activities and researchers will be able to assess the long term clinical impact of its use in real-world environments,” said Jung, who is interim dean of the university’s College of Engineering & Computing.

“This research journey started from foundational neuroscience and engineering principles to incorporating with painstaking accuracy the validation needed to make this system ready for clinical studies and this first-in-human trial. This unique system, integrating the long-term efforts of academia and industry, is an example of the bioengineering partnerships we promote,” added Grace Peng, program director at the NIH’s National Institute of Biomedical Imaging & Bioengineering.

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