Kardia 12L vs VisualDx
Kardia 12L lists at $2,295 including the device and KardiaPro access, and the listing does not say whether the price recurs. AliveCor's press page announced CMS reimbursement approval for the device in January 2025, and a 150-participant equivalence study of it was sponsored by the company. VisualDx lists no FDA clearance, and a 2020 vendor FAQ says it is not FDA approved. It sells a differential builder with, per its homepage, 50,000+ clinical images across skin tones and body sites. Elite for clinicians costs $299.99 per year billed annually, Core costs $249.99 per year billed annually, and groups of two to five users get a quote.
Cross-shopping is unlikely. A group costing out in-house 12-lead ECGs against that reimbursement announcement fits Kardia 12L, and a clinician who wants look-alike image comparison across skin tones, with patient handouts in English and Spanish, fits VisualDx.
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.
VisualDx
by VisualDx · founded 1999
Differential diagnosis builder with 50,000+ clinical images across skin tones and body sites.
When to pick each one
Kardia 12L
- Vendor announced CMS reimbursement approval, January 2025
- Equivalence study of 150 participants, vendor-sponsored
VisualDx
- Elite $299.99 per year, billed annually
- Vendor cites 50,000+ images across skin tones and body sites
- Vendor lists HL7 infobutton and SMART on FHIR as 2012 milestones
Score
Each row shows points earned of points available under the published rubric.
Kardia 12L
38of 100
VisualDx
48of 100
| Dimension | Kardia 12L | VisualDx | Difference |
|---|---|---|---|
| FDA clearance | 12 / 12 | 0 / 12 | +12 |
| 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 | 9 / 9 | -9 |
| Funding & adoption signal | 8.4 / 12 | 8.4 / 12 | 0 |
| Pricing transparency | 1.3 / 2.5 | 2.5 / 2.5 | -1.2 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
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. |
VisualDx
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Core (education) | n/a | $249.99 | Shown as $39.99 or $20.83 per month, billed annually. Free trial length is not stated. Annual plans that auto-renew have a 30-day grace period for a full refund of the renewed fee. |
| Elite (clinicians) | n/a | $299.99 | Shown as $49.99 or $24.99 per month, billed annually. |
| Groups and Enterprise | n/a | n/a | Contact for pricing, including small groups of 2 to 5 users. |
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
VisualDx
FDA decisions
No FDA decision cited in our research as of October 20, 2026.
Peer-reviewed
4 PubMed records name VisualDx.
- Early Perspectives on Utilization of a Clinical Decision Support Tool: A Mixed-Methods Study. (opens in new tab)
- Experiences, challenges and lessons while implementing a clinical decision support system in Botswana. (opens in new tab)
- Racial disparities in skin tone representation of dermatomyositis rashes: a systematic review. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Kardia 12L | VisualDx |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 1999 |
| 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.