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MyoVista wavECG logo

MyoVista wavECG

by HeartSciences  ·  US

Last verified

12-lead resting ECG device for cardiology clinics, FDA 510(k) cleared in October 2026 without its AI-ECG algorithm.

Visit MyoVista wavECG (opens in new tab)Read our methodology

At a glance

Pricing
No public price.
HIPAA
Attested
SOC 2
Not disclosed
EHRs
1
Founded
—
HQ
US
On this page

Independent score  ·  By our public rubric

31/100Competitive

Editorial rating 2.5 / 5

How it’s computed →
  • Regulatory & Compliance
    18/22

    FDA cleared (1 K-number on record)

  • Clinical Integration
    3.6/11.6

    epic only (1 of 3 top EHRs)

  • Evidence Strength
    0/30

    No peer-reviewed coverage

  • Vendor & Market
    3/18

    Seed-stage or unfunded

  • Sentiment & Transparency
    1.3/2.5

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance12/12

    FDA cleared (1 K-number on record)

  • HIPAA / SOC2 / BAA6/10

    Partial attestation (one of HIPAA / SOC2 / BAA)

Clinical Integration

  • EHR integrations (count)2/6

    1 EHR integrations

  • Top-3 EHR coverage (Epic / Oracle / Athena)2/5

    epic only (1 of 3 top EHRs)

  • 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 signal3/12

    Seed-stage or unfunded

  • 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

12-lead resting ECG device for cardiology clinics, FDA 510(k) cleared in October 2026 without its AI-ECG algorithm.

No public price. HIPAA-attested. integrates with Epic.

Evidence record

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

MedAI Verdict, MyoVista wavECG record, https://medaiverdict.com/tools/heartsciences, version November 2, 2026

Change history
View every change to this record

Bottom line

HeartSciences received FDA 510(k) clearance on October 5, 2026 (K260005) for the MyoVista wavECG, a 12-lead resting ECG with advisory interpretive statements. The clearance excludes the company's AI-ECG algorithm, and the company says it does not intend to commercialize the device without a cleared algorithm, giving no timeline. A clinic that wants only a cleared resting 12-lead can look at the device, while a buyer after AI-assisted ECG reading has nothing to purchase yet. A business combination with Fortitude Mining Holdings, Inc., announced in June 2026, is pending.

What does the October clearance cover?

K260005 is listed as "MyoVista wavECG (DG-200-B15-003)," product code DPS, substantially equivalent, decided October 5, 2026. Under its former name, Heart Test Laboratories, the company has no earlier clearance on record. The October 6 press release says the diastolic-dysfunction algorithm was separated from the submission after updated ASE guidance. The site footer says the company's AI-ECG products "are currently in development and not commercially available in the United States."

What is MyoVista Insights?

The vendor describes Insights as a "device-agnostic, next-generation ECG management system" that centralizes data from 12-lead devices and third-party AI-ECG models, with an algorithm marketplace that runs models in parallel and compares a patient's ECGs over time. The homepage links an Epic showroom listing. CE Mark, ISO 13485 and HIPAA appear as footer badges.

Who is the company, and what has it raised?

HeartSciences Inc. is based in Southlake, Texas, and trades on Nasdaq as HSCS. It calls itself "a healthcare information technology (HIT) company focused on advancing electrocardiography." The June 2022 IPO sold 1,500,000 units at $4.25 for gross proceeds of about $6.375 million, with The Benchmark Company as sole bookrunner. CB Insights lists about $23.7 million raised in total. The company was renamed from Heart Test Laboratories in October 2024.

The pending partner, Fortitude Mining Holdings, is owned by Digital Currency Group and described in the October release as a "venture mining platform" anchored in Zcash, with closing expected in the fourth calendar quarter of 2026.

What evidence and customers are on record?

PubMed returns two MyoVista hits and no validation of the Insights platform. No customer is named, and the testimonials on the site are unnamed.

What does it cost?

HeartSciences lists no price, and the AI product is not sold in the US.

The verdict

A clinic that wants a plain 12-lead can buy what K260005 cleared, a resting ECG with advisory statements for adults and children. A buyer who wants AI-assisted reading has no cleared algorithm to purchase, and the Fortitude Mining Holdings combination is expected to close in the fourth calendar quarter of 2026.

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
EnterpriseNot statedNot statedNo public price.

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

What deploys cleanly

Carries FDA 510(k), CE, ISO 13485, HIPAA per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment. Integrates with Epic.

Other decision support

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