International collaboration is key when it comes to scientific developments, and brain-computer interface (BCI) companies are quickly moving in that direction. INBRAIN Neuroelectronics, a leading Spanish-based company developing BCI therapies, has partnered with Mayo Clinic in Rochester, Minnesota, USA, to accelerate the advancement of its graphene-based brain technologies.
Last year, patients from all 50 U.S. states and 135 countries received care at Mayo Clinic. Widely recognized as one of the nation’s top research hospitals, Mayo Clinic topped U.S. News & World Report’s “Best Hospitals” rankings for 2025–2026—marking the 36th time it has held the No. 1 position since the rankings began.
The collaboration aims to bring precise BCI treatments to patients with neurological disorders that currently have limited treatment options.
“Our goal is to translate the unique performance of graphene and AI to deliver benefits for patients and clinicians,” said Carolina Aguilar, CEO and Co-Founder, INBRAIN Neuroelectronics, in a statement. “With Mayo Clinic’s clinical know-how, alongside other leading U.S. and European centers, we seek to validate our platform in real-world workflows, accelerate evidence generation, and move responsibly toward patient-focused BCI therapeutics.”
Navigating Regulatory Differences
European and U.S. BCI policies differ in their regulatory approaches, ethical oversight, and emphasis on data privacy. In an email to The Debrief, Aguilar explained, “In Europe, regulatory policy for BCIs has primarily followed the Medical Device Regulation (MDR) framework, which emphasizes safety, clinical evidence, and post-market surveillance for novel neurotechnology devices. In the U.S., the FDA regulates BCIs as medical devices, often requiring early engagement through programs like the Breakthrough Devices Program to align on study design and evidence requirements. The FDA has been proactive in establishing dedicated guidance around digital health and neurotechnology, while Europe has generally moved toward stricter conformity assessments under MDR. In short, Europe has a centralized CE-mark process with a strong emphasis on device classification, while the U.S. FDA process is more iterative and interactive.”
With its headquarters in Barcelona, INBRAIN has also announced plans to expand operations in the U.S., including opening offices in Boston and on the West Coast. The Boston office will focus on U.S.-based clinical trials and on preparing therapies for market expansion beyond Parkinson’s disease. The company’s main research center will remain in Barcelona.
“We’re approaching the U.S. pathway with early, structured engagement with FDA, via pre-submission meetings, the Breakthrough Devices Program where appropriate, and the Total Product Life Cycle Advisory Program (TAP), so our study design, endpoints, and evidence plan align with U.S. FDA expectations from the outset,” Aguilar told The Debrief in an email, in response to questions about how INBRAIN plans to navigate U.S. regulations around clinical trials and medical devices compared to Europe.
“TAP enables early, frequent, solutions-focused dialogue with FDA and, when relevant, other stakeholders, to streamline the path to patient access, while FDA Breakthrough Designation provides prioritized interaction and review for devices addressing serious conditions,” Aguilar said.
“In Europe, our first-in-human studies have been conducted under the MDR framework, and that experience provides a strong foundation,” she added. “Our goal is to harmonize the evidence package so both European and U.S. regulators can evaluate the safety and potential benefits of our graphene-based BCI platform consistently.”
Scaling for a Global Market
INBRAIN is currently working to manufacture its graphene-based platform at scale to compete in the rapidly growing global BCI market. To date, the company has raised $124 million from investors, including Mayo Clinic, European and Spanish government initiatives, and several venture capital firms.
“Europe has been very supportive of graphene innovation and neurotechnology. INBRAIN has benefited from programs such as the Graphene Flagship initiative, one of the largest European Commission-funded research efforts, as well as grants from the European Innovation Council (EIC) and support from the Spanish government and Catalonia regional initiatives,” Aguilar said.
Fundamentally, INBRAIN’s technology combines precise brain monitoring with tiny, targeted therapy adjustments, and with the implementation of AI, it can personalize treatment for conditions such as Parkinson’s disease, epilepsy, and stroke rehabilitation.
“These programs have provided critical early-stage funding and infrastructure that allowed us to scale our graphene-based BCI platform and advance toward clinical validation,” Aguilar says.
“That strong foundation has been key to our ability to expand internationally, including into the U.S.”
Chrissy Newton is a PR professional and founder of VOCAB Communications. She currently appears on The Discovery Channel and Max and hosts the Rebelliously Curious podcast, which can be found on YouTube and on all audio podcast streaming platforms. Follow her on X: @ChrissyNewton, Instagram: @BeingChrissyNewton, and chrissynewton.com.