MyoVista wavECG vs Implicity
FDA decided on HeartSciences' MyoVista wavECG in October 2026 as K260005. The decision covers a 12-lead resting ECG with advisory interpretive statements for adults and children and does not include an AI-ECG algorithm. The vendor's site says its AI-ECG products are in development and not commercially available in the United States.
Implicity holds three 510(k) decisions, the latest on July 2, 2026 for the ILR ECG Analyzer. The vendor says more than 250 medical centers use the platform across the US, France and Germany.
The products do different work. A cardiology clinic that wants a resting 12-lead ECG buys from HeartSciences. An electrophysiology group that follows pacemakers, ICDs and insertable cardiac monitors remotely buys from Implicity, a cloud service built for that follow-up.
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.
Implicity
by Implicity · founded 2016
Cloud platform for remote monitoring of pacemakers and ICDs, with AI alert filtering and heart failure risk scoring for device clinics.
When to pick each one
MyoVista wavECG
- Resting 12-lead ECG, cleared as K260005
- Site says AI-ECG products not yet sold in US
Implicity
- Remote follow-up of pacemakers, ICDs and loop recorders
- Three 510(k) decisions, latest July 2026
Score
Each row shows points earned of points available under the published rubric.
MyoVista wavECG
31of 100
Implicity
36of 100
| Dimension | MyoVista wavECG | Implicity | 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 | 8.4 / 21 | -8.4 |
| 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 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
MyoVista wavECG
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Implicity
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
MyoVista wavECG
FDA decisions
K260005 (opens in new tab)510(k)2026-10-05
MyoVista wavECG (DG-200-B15-003)
Implicity
FDA decisions
K253463 (opens in new tab)510(k)2026-07-02
ILR ECG Analyzer (IM007)
K230842 (opens in new tab)510(k)2023-10-25
SignalHF (IM008)
K210543 (opens in new tab)510(k)2021-11-03
IM007
Peer-reviewed
1 PubMed record names Implicity.
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | MyoVista wavECG | Implicity |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Epic | Not specified |
| Founded | n/a | 2016 |
| HQ | US | FR |
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.