Clinical Data and Supporting Evidence

The Ceribell Point-of-Care EEG system has been clinically demonstrated to empower physicians to make faster, more accurate diagnostic decisions for informed treatment plans.

Ceribell Point-of-Care EEG was demonstrated to significantly improve clinical accuracy and confidence58

The DECIDE study was a prospective, multi-center observational study that evaluated the clinical impact of Point-of-Care EEG.

  • Wait-time to Ceribell EEG was 5 Minutes compared to 4-hours with conventional EEG
  • Diagnostic accuracy with Ceribell EEG was 90% versus 65% Using Clinical Judgement Alone
  • Diagnostic confidence was 86% with Ceribell versus 40% Using Clinical Judgement Alone

Ceribell with Clarity provides 24/7 EEG monitoring with consistently high performance for seizure burden assessment and bedside alert53

The Clarity study was a retrospective, 6-center study that evaluated the performance of Clarity to measure the burden of seizure activity and generate bedside alerts for possible status epilepticus.
  • 100% Sensitivity for detecting and alerting for non-convulsive status epilepticus
  • 99% negative predictive value for ruling out seizure

Ceribell Brain Stethoscope® allows highly sensitive spot-checking for detection of seizures​47

This study compared the sensitivity and specificity of nurses and medical students for the detection of seizures using Brain Stethoscope versus that of EEG-trained neurologists.

69 nurses and medical students used the Brain Stethoscope function to evaluate EEG for seizure activity while 14 neurologists used the visual readout to evaluate the same EEGs.

  • Nurses and medical students had a higher sensitivity for the detection seizures when using Brain Stethoscope.

Ceribell electrode signal quality was equivalent to conventional EEG68

This study assessed signal quality of the Ceribell EEG system compared to that of two conventional EEG systems to confirm the Ceribell signal quality performance was equivalent to gold standard conventional EEG.

Ceribell electrodes were placed side-by-side on the same patient with traditional EEG system electrodes and simultaneous recordings were then compared.

  • The two EEG results showed equivalent signal quality and durability (see overlaid signal).

EEG recordings using a circumferential 10-electrode montage meet the gold standard for seizure detection61

This study assessed whether reduced montage EEG (rm-EEG) systems, like that used by Ceribell, meet the gold standard full-montage EEG (fm-EEG) for detection of seizures. In the case of discordant diagnoses, it further sought to determine whether the difference was due to electrode reduction or to asymmetric access to ancillary information.

212 fm-EEGs were reviewed with access to ancillary information. The same EEGs were converted to rm-EEG (10 electrodes) and different neurologists read them with no ancillary information. EEGs with discordant readings between the two groups were then reviewed again with no access to ancillary information.

  • The rm-EEG resulted in high diagnostic concordance (95%) with fm-EEG and high agreement between EEG-readers (93%) when ancillary information was equal.

Focal parasagittal and midline epileptiform activity is rare and can be seen in temporal leads69

A retrospective review of 300 EEGs and >169k cases reported in literature confirms that only 0.7% of EEGs show focal parasagittal/midline seizures.

  • The prevalence of midline or parasagittal abnormalities was only 0.71% (1,211 of 169,510) in the 16 published works
  • In a cohort of 300 patients, 17 were found to have seizure activity, and of these, only two were focal midline or parasagittal seizures and both could be detected in lateral chains of the EEG

Ceribell Point-of-Care EEG alters the treatment course for patients with suspected seizures and will result in cost savings per patient70

This study built a two-armed cost–benefit model comparing rapid EEG with clinical suspicion alone to examine the effect of Ceribell on hospital costs.

  • Ceribell led to reduction in the hospital LOS by 1.2 days (6.1 vs. 7.4 days) and ICU LOS by 0.4 days (1.5 vs. 1.9 days).
  • rapid EEG savings was $5,633 per use case (95% PI: $4,649 to $6,617)
  • Cost-savings were demonstrated in 75% of replications
  • 64% of variance in total costs was attributable to LOS for persons incorrectly diagnosed with seizures

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Caution: Federal (US) law restricts this device to sale by or on the order of a physician. The Ceribell EEG Headband and the Ceribell EEG Recorder are intended to be used by trained healthcare providers in a professional healthcare facility environment. The Ceribell EEG Recorder does not provide any diagnostic conclusion about the subject’s condition and does not provide any automated alerts of an adverse clinical event. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

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