Identify of Firm: Ceribell Inc
Rafael Donnay, vp of product and reimbursement on the Sunnyvale, California, firm, describes the main points of the FDA clearance of the ClarityPro software program system.
Identify of the Product:
ClarityPro
When did you obtain the clearance?:
Could 23, 2023
Describe the issue that the product addresses:
Analysis of ESE (Electrographic Standing Epilepticus) is crucial to treating extended seizures, which can have an effect on one-third of hospitalized neurological important care sufferers. These seizures improve the danger of everlasting mind damage. Early analysis & administration can dramatically enhance affected person outcomes. ClarityPro is now the primary and solely gadget to diagnose ESE in line with the American Medical Neurophysiology Society’s definition of ESE.
Who’s the end-user?:
Healthcare suppliers in ICUs and Emergency Departments
Does the product want reimbursement and is it lined?:
Further Medicare reimbursement will increase entry to this very important know-how to extra People, particularly seniors and critically ailing sufferers who usually tend to undergo from neurological sicknesses. With this approval, hospitals can obtain NTAP reimbursement of as much as $913.90 for eligible Medicare sufferers beginning in October 2023.
What are the aggressive merchandise in the marketplace?:
Zeto Wi-fi EEG Headset
Picture: jayk7, Getty Pictures and Ceribell
