Birth Model vs SimpleSense
Nanowear has four 510(k) clearances on openFDA, the newest K232053 for SimpleSense-BP in December 2023. openFDA lists no 510(k) under Birth Model or BirthModel, and neither the Birth Model homepage nor its company page makes an FDA or non-device decision support statement.
Nanowear's blood pressure paper followed 303 subjects for four weeks, with company authors and internal validation only, and the authors ask for external validation. Birth Model says it trained on 150,000 charts, and its pages name one birth center as a user and give no deployment count.
A cardiology practice or heart failure program that wants a cloth garment sending biomarkers from the patient's skin at home is Nanowear's customer. Birth Model sells to a hospital obstetrics service that wants a seven-day census forecast and staffing alerts tied to AWHONN guidance.
Decision support · Reviewed November 2, 2026
Birth Model
by Birth Model
Predictive AI for labor and delivery units: delivery timing, staffing forecasts and hemorrhage and preeclampsia risk alerts.
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
Birth Model
- Seven-day census forecast for labor units
- Staffing alerts tied to AWHONN guidance
SimpleSense
- Four FDA 510(k) clearances, latest December 2023
- Cloth garment for home heart failure monitoring
- Cuffless blood pressure estimation
Score
Each row shows points earned of points available under the published rubric.
Birth Model
25of 100
SimpleSense
49of 100
| Dimension | Birth Model | SimpleSense | Difference |
|---|---|---|---|
| FDA clearance | 0 / 12 | 12 / 12 | -12 |
| HIPAA / SOC2 / BAA | 10 / 10 | 0 / 10 | +10 |
| EHR integrations (count) | 1.7 / 5.6 | 0 / 5.6 | +1.7 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 4.8 / 4.8 | 0 / 4.8 | +4.8 |
| 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 | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Birth Model
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The pricing page returns 404; the site offers a demo and an ROI calculator only. |
SimpleSense
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Birth Model
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 | Birth Model | SimpleSense |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Epic, Oracle Health, athenahealth | Not specified |
| Founded | n/a | 2014 |
| HQ | n/a | 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.