KATE vs SimpleSense
openFDA lists four 510(k) clearances for Nanowear, from K161431 in 2016 to K232053 for SimpleSense-BP in December 2023, which names K212160 as its primary predicate. It lists none for Mednition. KATE Sepsis holds a Breakthrough Device Designation from November 2023, a status short of clearance.
Nanowear's cloth garment captures what the vendor calls more than 85 biomarkers from the skin, and the platform supports heart failure monitoring and blood pressure estimation without a cuff for patients at home. Its cuffless study had Nanowear-affiliated authors and internal validation only, and the authors call for external validation. Nanowear's setting is the patient's home. Mednition builds KATE for the ED nursing director, reading EHR data at triage to recommend acuity and flag sepsis risk, and its 2019 launch release described it as decision support designed for emergency nurses.
Decision support · Reviewed November 2, 2026
KATE
by Mednition · founded 2014
KATE AI recommends emergency department triage acuity and flags sepsis risk from EHR data at triage.
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
KATE
- Triage acuity recommendation at ED arrival
- Sepsis risk flag from EHR data
SimpleSense
- Four 510(k) clearances, latest December 2023
- Home garment for heart failure monitoring
- Cuffless blood pressure estimate in SimpleSense-BP
Score
Each row shows points earned of points available under the published rubric.
KATE
12of 100
SimpleSense
49of 100
| Dimension | KATE | SimpleSense | Difference |
|---|---|---|---|
| FDA clearance | 0 / 12 | 12 / 12 | -12 |
| 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 | 0 / 21 | 14.7 / 21 | -14.7 |
| RCT / meta-analysis / systematic review | 0 / 9 | 4.5 / 9 | -4.5 |
| Funding & adoption signal | 3 / 12 | 3 / 12 | 0 |
| Pricing transparency | 1.3 / 2.5 | 1.3 / 2.5 | 0 |
| Years in market | 6 / 6 | 6 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
KATE
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
SimpleSense
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
KATE
FDA decisions
No FDA decision cited in our research as of November 2, 2026.
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 | KATE | SimpleSense |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2014 | 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.