Ceribell vs SimpleSense
A hospital buys Ceribell's EEG recorder and portal for seizure burden and a delirium trend, and Ceribell says CMS set a New Technology Add-on Payment of up to $2,171 incremental for its delirium solution, effective October 1, 2026. The delirium output is a biomarker score updated every 10 seconds. A heart failure program issues Nanowear's SimpleSense, a cloth garment with cloud analytics, and SimpleSense-BP adds a cuffless blood pressure estimate.
Nanowear has four 510(k) clearances on openFDA, from SimplECG in November 2016 to SimpleSense-BP in December 2023, while its homepage says "FDA approved". A 2025 prospective multicentre study of 303 subjects over four weeks, written by Nanowear authors, validated the blood pressure estimate internally and asks for external validation. Third-party sources put Nanowear's funding at $1.52M (Tracxn) and under $5 million (ZoomInfo).
Decision support · Reviewed November 2, 2026
Ceribell
by Ceribell
Point-of-care EEG headband with AI seizure detection and a delirium monitor, for hospitals, ICUs and emergency departments.
SimpleSense
by Nanowear · founded 2014
Cloth wearable with 510(k) cleared AI cloud analytics for remote cardiac monitoring and cuffless blood pressure.
When to pick each one
Ceribell
- Vendor-stated CMS add-on payment up to $2,171 for delirium
- Bedside EEG recorder for hospital patients
SimpleSense
- Home-worn garment for heart failure monitoring
- Four 510(k) clearances, newest SimpleSense-BP in December 2023
Score
Each row shows points earned of points available under the published rubric.
Ceribell
49of 100
SimpleSense
49of 100
| Dimension | Ceribell | SimpleSense | Difference |
|---|---|---|---|
| FDA clearance | 12 / 12 | 12 / 12 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 5.6 | 0 / 5.6 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 4.8 | 0 / 4.8 | 0 |
| Bidirectional write-back | 0 / 1.2 | 0 / 1.2 | 0 |
| Peer-reviewed papers | 14.7 / 21 | 14.7 / 21 | 0 |
| RCT / meta-analysis / systematic review | 4.5 / 9 | 4.5 / 9 | 0 |
| Funding & adoption signal | 8.4 / 12 | 3 / 12 | +5.4 |
| Pricing transparency | 1.3 / 2.5 | 1.3 / 2.5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Ceribell
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Purchase terms: one-year initial term, auto-renewing yearly unless 90 days notice. |
SimpleSense
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Ceribell
FDA decisions
K261712 (opens in new tab)510(k)2026-09-16
Ceribell EEG Analysis Software
K261101 (opens in new tab)510(k)2026-06-30
Ceribell Monitor
K260998 (opens in new tab)510(k)2026-06-24
Ceribell Neurology Review Software
K260363 (opens in new tab)510(k)2026-04-03
Ceribell Brain Monitor Headband
K254033 (opens in new tab)510(k)2026-02-09
Ceribell Instant EEG Headset
Show 11 more
K251936 (opens in new tab)510(k)2025-12-08
Ceribell Delirium Monitor System
K252070 (opens in new tab)510(k)2025-11-21
Ceribell Infant Seizure Detection Software
K251381 (opens in new tab)510(k)2025-10-31
Ceribell Instant EEG Headcap
K241589 (opens in new tab)510(k)2025-04-09
Ceribell Seizure Detection Software
K232052 (opens in new tab)510(k)2023-08-08
Ceribell Instant EEG Headband
K223504 (opens in new tab)510(k)2023-05-23
Ceribell Status Epilepticus Monitor
K223086 (opens in new tab)510(k)2023-03-22
Ceribell Instant EEG Headcap
K210805 (opens in new tab)510(k)2021-08-30
Ceribell Instant EEG Headband
K191301 (opens in new tab)510(k)2019-09-11
Ceribell Pocket EEG Device
K171459 (opens in new tab)510(k)2017-08-21
Ceribell Instant EEG Headband
K170363 (opens in new tab)510(k)2017-05-08
Ceribell Pocket EEG Device
Peer-reviewed
4 PubMed records name Ceribell.
- Automated Seizure Detection in Patients with Cardiac Arrest: A Retrospective Review of Ceribell™ Rapid-EEG Recordings. (opens in new tab)
- Point-of-Care EEG Artificial Intelligence Measure of Seizure Burden Associates With Clinical Outcome at Discharge. (opens in new tab)
- Assessing the performance of artificial intelligence in detecting electrographic status epilepticus when human experts often disagree. (opens in new tab)
SimpleSense
FDA decisions
K232053 (opens in new tab)510(k)2023-12-08
SimpleSense-BP, SimpleSense-BP Software Application
K212160 (opens in new tab)510(k)2021-09-22
SimpleSENSE Platform
K201669 (opens in new tab)510(k)2020-11-06
SimpleSENSE
K161431 (opens in new tab)510(k)2016-11-30
SimplECG
Peer-reviewed
3 PubMed records name SimpleSense.
- Multiparametric cloth-based wearable, SimpleSense, estimates blood pressure. (opens in new tab)
- Development and Internal Validation of an AI-Enabled Cuff-less, Non-invasive Continuous Blood Pressure Monitor Across All Classes of Hypertension. (opens in new tab)
- Nanotechnology and Artificial Intelligence: An Emerging Paradigm for Postoperative Patient Care. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Ceribell | SimpleSense |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2014 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
Open the full decision support comparison
Differential diagnosis, treatment guidance, drug interactions, evidence-grounded Q&A. The CDS landscape ranges from the UpToDate gold standard to physician-only OpenEvidence. We compared what clinicians actually use.