The recent launch of the Implantable Brain Computer Interface Collaborative Community (iBCI-CC) marks a major milestone in the evolution of the healthtech and Brain-Computer Interface (BCI) industry. In a first-of-its-kind alliance, five major U.S. neurotechnology companies have joined forces with ALS and spinal cord injury patient advocacy groups, leading academic ethicists and researchers, and, crucially, regulators from the Food and Drug Administration and Commerce Department. The spirit at these meetings is energized, collaborative, and driven by a shared mission to advance patient care. The BCI market size is poised for exponential growth, but this kind of cross-sector collaboration is what will determine its long-term success.

The FDA’s Pivotal Role in Advancing Neurotechnology

The first demonstrations of computer control by a person using an implanted brain-computer interface took place in the early 2000s, a challenging era for innovative healthtech device companies. Regulatory pathways were uncharted, and there were no predicate technologies to guide approval. In 2010, Josh Makower, MD of Stanford Medicine, co-authored an influential report titled FDA Impact on U.S. Medical Technology Innovation. After surveying more than 200 medical device companies, the conclusion was stark: “Unpredictable, inefficient, and expensive regulatory processes are jeopardizing America’s leadership position in medtech innovation.”

The FDA took notice. Its first major step was launching the Early Feasibility Study (EFS) Program, designed to give U.S. patients first access to breakthrough medical technologies and discourage companies from conducting trials overseas. This was a critical move for the neurotechnology field, enabling early clinical trials while carefully managing safety risks.

Over the following decade, the FDA introduced the Breakthrough Device Program to speed patient access to life-changing medical devices, followed by the TAP Program, which accelerates collaboration with companies for even faster approvals. 

In 2021, the FDA published a dedicated guidance document for implantable BCI devices, in response to the development efforts and clinical progress, in which the Agency acknowledged:

“The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access. Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life.”

A New Era for the BCI Industry

Equally important to policy reform has been the growing presence of scientists and engineers in regulatory science.

“Many of us in the scientific community felt that the place where we could best effect bringing therapies to patients would be in the field of regulatory science” said Devjani Saha, PhD, Director, Neurology Regulatory Affairs at MCRA.

Today’s FDA looks very different from two decades ago. Many in the FDA Office of Neurological and Physical Medicine Devices have direct BCI experience, including Director David McMullen, MD—a neurosurgeon and former NIH BCI researcher. In a recent Medtech Insight interview, McMullen described the TAP Program as “almost breakthrough on steroids,” noting that it brings all stakeholders together to solve not only regulatory hurdles but also real-world patient access issues.

Opportunities and Challenges in a Growing BCI Market

The BCI market size is expanding rapidly as more companies enter pivotal trials and attract significant venture capital. Synchron is transitioning from a successful early feasibility study to a pivotal trial, Paradromics successfully tested their device in a human patient, while Neuralink recently faced a mechanical device failure in its first patient. The neurotechnology industry will see both high-profile successes and setbacks as it matures, but investors remain bullish.

“This BCI industry has gone from 0-60 in the last few years” says Paradromics investor and Board Member, Amy Kruse, “and now that the FDA is signaling its willingness to lean in and accelerate innovation, investment in the space will only heat up.”

The Future of Healthtech and Neurotechnology

For healthtech innovators in the neurotechnology sector, the combination of regulatory clarity, collaborative frameworks like the iBCI-CC, and growing capital investment creates a rare opportunity. The path ahead will involve rigorous testing, transparent communication, and the ability to navigate both technical and ethical complexities. But the prize is worth it: faster access to life-changing devices for the people who need them most.

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