MCRA Supports Ceribell in Securing FDA Breakthrough Status, Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device

Tuesday, September 26, 2023

MCRA, LLC, a leading firm specializing in medical device regulatory advisory services and clinical research, is proud to announce its pivotal role in obtaining FDA Breakthrough Device Designation, FDA marketing authorization, and CMS New Technology Add-on Payment (NTAP) for Ceribell, Inc.'s groundbreaking ClarityPro device. ClarityPro is a revolutionary device that utilizes machine learning to analyze signals from Ceribell's EEG system, allowing for the diagnosis of Electrographic Status Epilepticus (ESE), a life-threatening condition.

MCRA's Neurology and Digital Health regulatory teams played a critical role in securing both the Breakthrough Device Designation and the 510(k) premarket notification clearance for Ceribell's ClarityPro device. Notably, ClarityPro is the first ICU monitoring device to receive CMS NTAP reimbursement. This reimbursement mechanism provides additional payments to hospitals using the device, addressing cost concerns often associated with adopting new medical technologies.

This achievement represents a significant milestone for Ceribell, as it marks the first time both the Breakthrough Designation and 510(k) clearance have been obtained for their innovative ClarityPro device. The ClarityPro device promises to advance patient care for those dealing with seizure activity. MCRA's assistance with the NTAP application underscores their commitment to facilitating the device's successful adoption upon launch.
The convergence of the FDA Breakthrough Device program and the CMS NTAP alternative pathway for breakthrough devices is a recent and noteworthy development. MCRA's unique expertise and experience in both areas position them effectively to navigate these intricate regulatory landscapes.

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