US-based non-profit healthcare system Mass General Brigham is establishing a group aimed at advancing implantable brain-computer interfaces by bringing industry stakeholders together into a single initiative.
The Implantable Brain-Computer Interface Collaborative Community (iBCI-CC) aims to accelerate the safety and development of brain interface devices with stakeholders, including the US Food and Drug Administration (FDA).
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The iBCI-CC plans to bring together researchers, clinicians, medical device manufacturers, patient advocacy groups, as well as patients living with neurological conditions and has additionally vowed it will hold regular meetings open both to its members and the public to ensure inclusivity and transparency.
David McMullen, director of the Office of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health, said: “Brain-computer interfaces have the potential to restore lost function for patients suffering from a variety of neurological conditions.
“However, there are clinical, regulatory, coverage and payment questions that remain, which may impede patient access to this novel technology.”
The field of potential brain implants has seen rapidly growing interest over the past few years, a market model by GlobalData estimates that the global neuromodulation device market was worth $11.4bn by the end of 2033, up from $6bn in 2022. The scene has already seen the entrance of several notable figures and companies, including the Elon Musk-owned Neuralink.
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By GlobalDataLeigh Hochberg, a founding member and director of the Center for Neurotechnology and Neurorecovery at Massachusetts General Hospital, detailed how safety was the key goal of the group.
Hochberg said: “As a neurointensive care physician, I know how many patients with neurologic disorders could benefit from these devices. Increasing discoveries in academia and the launch of multiple iBCI and related neurotech companies means that the time is right to identify common goals and metrics so that iBCIs are not only safe and effective but also have thoroughly considered the design and function preferences of the people who hope to use them.”
Elsewhere in the field of brain implants, Onward Medical has been accepted into the FDA’s total product life cycle advisory programme (TAP) for its brain-computer interface (BCI) technology, where it joins a second unnamed company.
