The first critical care monitoring device to achieve FDA Breakthrough Designation for the diagnosis of electrographic status epilepticus with an exclusive New Technology Add-on Payment (NTAP) from CMS
ClarityPro is a machine learning algorithm that interprets EEG signals and provides alerts when continuous seizures indicating status epilepticus are detected.
At the bedside, ClarityPro delivers 24/7 bedside EEG monitoring and alerts:
The first FDA-cleared instantaneous bedside alert diagnosing electrographic status epilepticus
Continuous EEG monitoring and seizure burden display
Remotely, ClarityPro provides:
The first FDA-cleared seizure burden trend with pre-annotations to support efficient EEG interpretation
Accurate EEG seizure burden labeling
Real-time medication effectiveness
Intuitive medication response monitoring for treatment optimization in real-time
How Does ClarityPro Work?*
Clarity is a machine-learning, cloud-based AI algorithm that interprets the EEG every 10 seconds across all EEG channels to provide a seizure burden estimate.
Seizure burden is the amount of seizure activity detected in the prior 5-minute window. Prolonged seizures, such as status epilepticus, which is associated with poor neurological outcomes, display a high seizure burden.
Clarity AI is designed to provide clinically meaningful information
- Automatically detect suspected non-convulsive status epilepticus at the bedside
- Diagnose electrographic status epilepticus with Clarity Plus
- Continuously monitor the EEG for ongoing seizure burden
- Trained on thousands of EEG annotated by epileptology experts and continuously improving
- Clinically proven to detect or rule out status epilepticus at the case-level
- EEG offers one component of diagnostic insight. The decision to administer treatment, or not, should consider the combination of clinical history, patient presentation, and objective data.
- Inter-rater variability of EEG diagnoses is well-documented among expert readers. Since ClarityPro AI is trained based on expert input, a degree of inter-rater variability between Clarity AI’s output and the interpretation of the same case by a skilled neurologist should be expected.
- The capability and accuracy of the ClarityPro AI continues to improve with increased training on a growing volume of cases.
- ClarityPro AI is designed as an acute care tool to measure the overall burden of seizures, rather than detailed labeling of each individual epileptiform event, since the cumulative impact of seizure activity has greater impact on acute patient management and prognosis.
*Kamousi, B., et al. (2022) American Epilepsy Society Abstract 1.475