Client Need
Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. Fasikl have developed a groundbreaking approach that integrates cloud-based AI with neurostimulation to aid in the treatment of upper limb essential tremor. MCRA was engaged for multiple services to support the development of their 510(k) for the Felix NeuroAI™ Wristband, a first-of-its-kind noninvasive, drug-free alternative to surgery and medications, providing all-day relief for adults living with essential tremor.
With MCRA's expert guidance for US Regulatory, Biocompatibility, and Digital Health, Fasikl received FDA 510(k) Clearance for their Felix NeuroAI™ Wristband.
MCRA Approach
MCRA helped Fasikl receive 510(k) clearance for the Felix NeuroAI™ Wristband.
MCRA THERAPY: Neurology
MCRA SERVICES: US Regulatory, Biocompatibility, Digital Health
Outcome
MCRA’s Devjani Saha led a team of broad and diverse subject matter experts from Fasikl and MCRA to complete the 510(k) process. MCRA
worked with Fasikl to develop a strategy to present their AI algorithm and the clinical evidence to support not only safety and effectiveness of the Felix NeuroAI™ Wristband but also demonstrate clinically meaningful results. MCRA worked closely with Fasikl to develop the documentation and testing needed to support the 510(k), advised Fasikl on their EMC and electrical safety testing approach, and helped draft responses to FDA’s request for additional information. MCRA also led meetings with the FDA to discuss the clinical trial findings.
“Essential tremor affects approximately 7 million people in the U.S., yet treatment options remain limited. MCRA was a critical partner in our 510(k) clearance journey, serving as a “one-stop shop” for development and regulatory support. Their expertise in EMC, biocompatibility, AI, software, and regulatory affairs proved invaluable.
Through careful planning, rigorous preparation, and structured FDA interactions, we achieved 510(k) clearance of Felix on schedule.”
"Fasikl’s 510(k) clearance is anchored by a well-executed clinical study. The development of the 510(k) required significant collaboration between MCRA and Fasikl. The clinical study results demonstrate a notable benefit-risk profile that presented a compelling case of how wearable technology and AI can deliver safe and clinically meaningful treatment for upper limb essential tremor. The FDA provided valuable feedback during the course of the pre-submission and the 510(k) which ensured a rigorous and thorough review of the clinical evidence."
“MCRA’s neurology regulatory team is honored to have played a key role in helping Fasikl obtain FDA clearance for the first closed loop neurotherapeutics device based on AI. From start to finish, the Felix NeuroAI Wristband’s 510(k) clearance is an excellent example of how smooth the process can be when all teams are working in concert towards the same goal. When leadership at a device manufacturer is able to set clear expectations for their team from the very beginning, this helps drive efficiency. MCRA is pleased to have been able to support Fasikl’s regulatory efforts, providing strategic guidance and expertise along the way to help the company achieve their goals. And finally, interactions with the FDA review team throughout were incredibly productive, ensuring that the Fasikl and MCRA teams clearly understood the necessary directions to take. Overall, clear communication on all sides was a major contributing factor to the eventual clearance.”
