Ceribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityPro™ Software with Electrographic Status Epilepticus Diagnostic Indication
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Thursday, August 3, 2023
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SUNNYVALE, Calif., Aug. 3, 2023 /PRNewswire/ -- Ceribell, Inc.® today announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. Centers for Medicare and Medicaid Services (CMS) granted New Technology Add-on Payment (NTAP) for ClarityPro of up to $913.90 per eligible Medicare patient case.
Key Points:
- SUNNYVALE, Calif., Aug. 3, 2023 /PRNewswire/ -- Ceribell, Inc.® today announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE).
- ClarityPro is now the only FDA-indicated device for the diagnosis of ESE in adult patients over the age of 18.
- ClarityPro is also the first and only device to offer NTAP reimbursement for the diagnosis of ESE.
- For additional information about the FDA Breakthrough Device program, the CMS NTAP program, and status epilepticus, visit https://ceribell.com/ClarityPro .