Kardia 12L vs Sepsis ImmunoScore
Prenosis holds the FDA De Novo authorization for Sepsis ImmunoScore (DEN230036, April 2024), and a hospital treating suspected sepsis in its ED is the buyer. The tool scores adults from up to 22 EHR parameters and sorts them into four risk bands for deterioration within 24 hours. The vendor says the model is locked and has not been validated in ICU or Labor and Delivery units, and the product page names no EHR vendor. A 2024 NEJM AI development and validation paper was written by Prenosis authors, and none of the papers found is an independent prospective outcome trial. Kardia 12L, from AliveCor, is a 12-lead ECG recorder for a cardiology practice. AliveCor announced new FDA-cleared cardiac determinations in January 2026, taking its count to 39, and a vendor press release from January 2025 describes a sponsored 150-participant equivalence study.
Decision support · Reviewed November 2, 2026
Kardia 12L
by AliveCor
Portable 12-lead ECG device with FDA-cleared AI interpretation, sold to clinicians with KardiaPro patient management access.
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
Kardia 12L
- 12-lead ECG recorder with AI interpretation
- New cleared determinations announced January 2026
Sepsis ImmunoScore
- FDA De Novo authorization DEN230036
- Sepsis risk from up to 22 EHR parameters
Score
Each row shows points earned of points available under the published rubric.
Kardia 12L
38of 100
Sepsis ImmunoScore
37of 100
| Dimension | Kardia 12L | Sepsis ImmunoScore | Difference |
|---|---|---|---|
| FDA clearance | 12 / 12 | 12 / 12 | 0 |
| HIPAA / SOC2 / BAA | 10 / 10 | 0 / 10 | +10 |
| 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 | 0 / 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 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Kardia 12L
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Kardia 12L | n/a | n/a | Includes the device, KardiaStation app, KardiaPro access and a 3-year warranty, with a 90-day return policy. Two-week trial for eligible U.S. HCPs by form. The page does not state whether the price is one-time or recurring. |
Sepsis ImmunoScore
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Demo or contact only. |
Evidence
Kardia 12L
FDA decisions
K252589 (opens in new tab)510(k)2026-01-09
Corvair Monza
K231010 (opens in new tab)510(k)2024-06-07
Corvair
K232035 (opens in new tab)510(k)2024-06-07
Impala
K220350 (opens in new tab)510(k)2022-05-25
KardiaMobile 6L
K212662 (opens in new tab)510(k)2022-04-26
AliveCor QT Service
Show 14 more
K211668 (opens in new tab)510(k)2021-11-30
KardiaMobile Card
K210753 (opens in new tab)510(k)2021-06-30
KardiaMobile 6L
K201985 (opens in new tab)510(k)2020-11-12
KardiaAI
K191406 (opens in new tab)510(k)2020-01-24
KardiaMobile, KardiaStation
K183319 (opens in new tab)510(k)2019-05-10
Triangle System
K181823 (opens in new tab)510(k)2019-04-12
KardiaAI
K182396 (opens in new tab)510(k)2019-04-12
KardiaMobile, KardiaStation
K171816 (opens in new tab)510(k)2017-11-16
Kardia Band System
K142743 (opens in new tab)510(k)2015-01-27
AliveCor Heart Monitor
K142672 (opens in new tab)510(k)2014-12-03
AliveCor Heart Monitor
K140933 (opens in new tab)510(k)2014-08-15
AliveCor Heart Monitor
K130921 (opens in new tab)510(k)2014-02-06
AliveCor Heart Monitor
K130409 (opens in new tab)510(k)2013-09-06
AliveCor Heart Monitor
K122356 (opens in new tab)510(k)2012-11-19
AliveCor Heart Monitor for iPhone
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 | Kardia 12L | Sepsis ImmunoScore |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | 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.