MyoVista wavECG vs Sepsis ImmunoScore
Prenosis holds FDA De Novo DEN230036, decided April 2, 2024, for Sepsis ImmunoScore. The score draws on up to 22 EHR parameters and places a patient in one of four bands for deterioration within 24 hours. It is built for hospital teams that run sepsis screening.
HeartSciences, listed on Nasdaq since its June 2022 IPO, sells a resting ECG device with advisory interpretive statements. Its press release says the company does not intend to commercialize that device without a cleared AI-ECG algorithm, and gives no timeline. The device suits a cardiology clinic buying ECG hardware, and the site says its AI-ECG products are not commercially available in the United States.
The sepsis team gets a risk band from Prenosis, and the cardiology clinic gets a resting ECG from HeartSciences, whose clearance does not include an AI-ECG algorithm.
Decision support · Reviewed November 2, 2026
MyoVista wavECG
by HeartSciences
12-lead resting ECG device for cardiology clinics, FDA 510(k) cleared in October 2026 without its AI-ECG algorithm.
Sepsis ImmunoScore
by Prenosis
AI sepsis risk score from up to 22 EHR parameters for adults with suspected sepsis in the ED or hospital, FDA De Novo authorized.
When to pick each one
MyoVista wavECG
- Resting ECG device with advisory interpretive statements
- Nasdaq-listed since a June 2022 IPO
Sepsis ImmunoScore
- FDA De Novo for sepsis risk, April 2024
- Up to 22 EHR parameters, four risk bands
- Vendor: not validated for ICU or labor and delivery
Score
Each row shows points earned of points available under the published rubric.
MyoVista wavECG
31of 100
Sepsis ImmunoScore
37of 100
| Dimension | MyoVista wavECG | Sepsis ImmunoScore | Difference |
|---|---|---|---|
| FDA clearance | 12 / 12 | 12 / 12 | 0 |
| HIPAA / SOC2 / BAA | 6 / 10 | 0 / 10 | +6 |
| EHR integrations (count) | 1.7 / 5.6 | 0 / 5.6 | +1.7 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 1.9 / 4.8 | 0 / 4.8 | +1.9 |
| 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 | 0 / 9 | 0 |
| Funding & adoption signal | 3 / 12 | 3 / 12 | 0 |
| Pricing transparency | 1.3 / 2.5 | 1.3 / 2.5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
MyoVista wavECG
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Sepsis ImmunoScore
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Demo or contact only. |
Evidence
MyoVista wavECG
FDA decisions
K260005 (opens in new tab)510(k)2026-10-05
MyoVista wavECG (DG-200-B15-003)
Sepsis ImmunoScore
FDA decisions
DEN230036 (opens in new tab)De Novo2024-04-02
Sepsis ImmunoScore
Peer-reviewed
2 PubMed records name Sepsis ImmunoScore.
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | MyoVista wavECG | Sepsis ImmunoScore |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Epic | Not specified |
| Founded | n/a | n/a |
| 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.