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Kardia 12L logo

Kardia 12L

by AliveCor  ·  US

Last verified

Portable 12-lead ECG device with FDA-cleared AI interpretation, sold to clinicians with KardiaPro patient management access.

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At a glance

Pricing
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.
HIPAA
Attested
SOC 2
Type II
EHRs
—
Founded
—
HQ
US
On this page

Independent score  ·  By our public rubric

38/100Competitive

Editorial rating 3.0 / 5

How it’s computed →
  • Regulatory & Compliance
    22/22

    FDA cleared (19 K-numbers on record)

  • Clinical Integration
    0/11.6

    No EHR integrations listed

  • Evidence Strength
    0/30

    No peer-reviewed coverage

  • Vendor & Market
    8.4/18

    Mid-tier funding and adoption

  • Sentiment & Transparency
    1.3/2.5

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance12/12

    FDA cleared (19 K-numbers on record)

  • HIPAA / SOC2 / BAA10/10

    HIPAA + (SOC2 or BAA) attested

Clinical Integration

  • EHR integrations (count)0/6

    No EHR integrations listed

  • Top-3 EHR coverage (Epic / Oracle / Athena)0/5

    None of the top-3 EHRs covered

  • Bidirectional write-back0/1

    No bidirectional write-back documented

Evidence Strength

  • Peer-reviewed papers0/21

    No peer-reviewed coverage

  • RCT / meta-analysis / systematic review0/9

    No RCT, meta-analysis, or systematic review

Vendor & Market

  • Funding & adoption signal8/12

    Mid-tier funding and adoption

  • Years in market0/6

    Founded year not recorded

Sentiment & Transparency

  • Pricing transparency1/3

    Pricing on request, no public amounts

Scored November 2, 2026 · Public scoring method v1.2.0

Portable 12-lead ECG device with FDA-cleared AI interpretation, sold to clinicians with KardiaPro patient management access.

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. HIPAA + SOC 2 Type II attested.

Evidence record

FDA decisions
Show 14 more
Verification
  • Score computed November 2, 2026, method 1.2.0
  • Review written November 2, 2026
Cite this record

MedAI Verdict, Kardia 12L record, https://medaiverdict.com/tools/alivecor, version November 2, 2026

Change history
View every change to this record

Bottom line

AliveCor, based in Mountain View, California, sells consumer KardiaMobile devices and a clinician line built around the Kardia 12L and KardiaMobile 6L, with AI interpretation and KardiaPro for storing and reviewing recordings. The Kardia 12L lists at $2,295. No FDA record carries the name "Kardia 12L". It suits a practice that wants a 12-lead tracing from a small device at a printed price, and not a buyer who needs one FDA decision tied to the 12L by name.

Which FDA decision is the Kardia 12L?

AliveCor holds 19 510(k) clearances, among them KardiaMobile 6L (K210753, K220350), KardiaAI (K181823, K201985), Impala (K232035), Corvair (K231010) and Corvair Monza (K252589), and the vendor does not state which covers the Kardia 12L. Dates and predicates, as the FDA records give them:

  • K181823 (April 12, 2019) and K201985 (November 12, 2020), KardiaAI.
  • K210753 (June 30, 2021) and K220350 (May 25, 2022), KardiaMobile 6L.
  • K231010 (June 7, 2024), Corvair, with GE's 12SL (K141963) as predicate.
  • K232035 (June 7, 2024), Impala, with VectraCor's K173952 as predicate.
  • K252589 (January 9, 2026), Corvair Monza, with K231010 as predicate.

The predicates belong to GE and VectraCor. The vendor says the 12L carries 39 FDA-cleared determinations, announced on January 13, 2026, and the 6L carries 35.

What evidence exists for the 12L?

Vendor-sponsored work dominates the 12L. A 150-participant equivalence study of the 12L was sponsored by AliveCor (press release, January 14, 2025), and only three PubMed papers carry the name "Kardia 12L". The clearest independent source is a 2024 Health Technology Assessment report (PMID 38551306) from the NICE early value assessment of the 6L for QT interval in people on antipsychotics. Other papers on the 6L include:

  • PMID 40395421 (Eur Heart J Digit Health, 2025), an AI-enhanced six-lead portable ECG for left ventricular systolic dysfunction.
  • PMID 38894503 (J Cardiovasc Electrophysiol, 2024), the 6L against a 12-lead for clinic utilization time.
  • PMID 33517677 (Circulation, 2021), AI-enabled QTc on a mobile ECG, with vendor-affiliated authors.

A Trustpilot reviewer of the 12L, undated, wrote that a password was required even offline and the reset did not work.

What does the 12L cost and how is data handled?

As of November 2026 the product page lists the Kardia 12L at $2,295, covering the device, the KardiaStation app, KardiaPro access, a 3-year warranty and a 90-day return period. Whether $2,295 recurs is not stated. Eligible US clinicians can request a two-week trial.

AliveCor's security page says Kardia and KardiaPro are HIPAA compliant and lists SOC 2 Type 2 "with zero exceptions listed", ISO 27001, and an ISO 42001 AI management certification covering Kardia AI V2 and Corvair. No EHR is named, though an API and SDK page exists, and the company announced a GE HealthCare integration at Hannover Medical School on November 3, 2025.

The company also announced a European launch of the 12L on April 15, 2026 and, as a press headline, CMS reimbursement approval for the Kardia 12L on January 16, 2025. The vendor claims 3 million or more lifetime users and 200 or more clinical publications.

The verdict

The 12L ships with a printed price, a stated security posture and a trial offer. Its sponsor-run equivalence data and the vendor's count of 39 determinations come from AliveCor, and the independent NICE report covers the 6L.

Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.

What it costs

All tiers are custom-quoted. The vendor does not publish per-provider list pricing.

TierMonthlyAnnualNotes
Kardia 12LNot statedNot statedIncludes 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.

Source: vendor pricing page. Last checked November 2, 2026.

What deploys cleanly

Carries FDA 510(k), HIPAA, SOC 2 Type II, ISO 27001, ISO 42001 per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

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