Zio vs VisualDx
By the vendor's count, VisualDx holds more than 50,000 clinical images across skin tones and body sites behind a differential builder. Its history page lists HL7 infobutton and SMART on FHIR as 2012 milestones, and the homepage mentions EHR integration, single sign-on and API access, but no EHR is named. VisualDx states no FDA clearance, and a 2020 DermExpert FAQ says it is exempt from FDA regulation.
iRhythm holds 18 FDA 510(k) clearances dating from 2008, the latest for the ZEUS Platform on May 29, 2026. The vendor calls its deep-learned algorithm the first FDA-cleared one verified by qualified cardiac technicians and reports 99% physician agreement on end-of-wear reports. A clinician who wants an image-led differential buys VisualDx, and a health system ordering ambulatory ECG monitoring buys Zio. VisualDx cannot supply the second, and Zio supplies no differential.
Decision support · Reviewed November 2, 2026
Zio
by iRhythm Technologies · founded 2006
Zio ECG patch service: a deep-learning algorithm flags arrhythmias, cardiac technicians validate them, and a physician report follows.

VisualDx
by VisualDx · founded 1999
Differential diagnosis builder with 50,000+ clinical images across skin tones and body sites.
When to pick each one
Zio
- 18 FDA 510(k) clearances, latest in May 2026
- Vendor reports 99% physician agreement on reports
VisualDx
- Vendor says 50,000+ clinical images across skin tones
- Elite $299.99 per year, billed annually
Score
Each row shows points earned of points available under the published rubric.
Zio
69of 100
VisualDx
48of 100
| Dimension | Zio | VisualDx | Difference |
|---|---|---|---|
| FDA clearance | 12 / 12 | 0 / 12 | +12 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| 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 | 21 / 21 | 14.7 / 21 | +6.3 |
| RCT / meta-analysis / systematic review | 9 / 9 | 9 / 9 | 0 |
| 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 | 6 / 6 | 6 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Zio
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
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
Zio
FDA decisions
K252859 (opens in new tab)510(k)2026-05-29
ZEUS Platform (FG0501US, DQK)
K243650 (opens in new tab)510(k)2025-08-15
Zio monitor (DFG0001)
K240177 (opens in new tab)510(k)2024-10-30
Zio AT device (A100A1001, DSI)
K240029 (opens in new tab)510(k)2024-10-21
Zio AT device (A100A1001, QYX)
K222389 (opens in new tab)510(k)2023-02-15
ZEUS System
Show 13 more
K213409 (opens in new tab)510(k)2022-07-19
ZEUS System (Zio Watch)
K202359 (opens in new tab)510(k)2021-05-21
Zio Monitor
K202527 (opens in new tab)510(k)2021-05-21
ZEUS System
K190593 (opens in new tab)510(k)2019-08-23
Zio XT ECG Monitoring System, Zio AT
K181502 (opens in new tab)510(k)2018-08-29
Zio AT ECG Monitoring System, ZEUS System
K163512 (opens in new tab)510(k)2017-06-02
Zio AT ECG Monitoring System
K143513 (opens in new tab)510(k)2015-06-19
ZIO SR ECG Monitoring Service
K142681 (opens in new tab)510(k)2014-11-21
ZEUS System
K121319 (opens in new tab)510(k)2012-07-18
ZIO PATCH
K113862 (opens in new tab)510(k)2012-02-06
ZIO PATCH
K091075 (opens in new tab)510(k)2009-07-21
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
K090363 (opens in new tab)510(k)2009-05-08
ZIO PATCH Z100
K081471 (opens in new tab)510(k)2008-06-24
ECARD AND CCARD
Peer-reviewed
5 PubMed records name Zio.
- Physical activity cut-points for older adults using the Zio XT onboard accelerometer. (opens in new tab)
- Validation of a Zio XT Patch Accelerometer for the Objective Assessment of Physical Activity in the Atherosclerosis Risk in Communities (ARIC) Study. (opens in new tab)
- Zio® XT Patches in Pediatrics During the COVID-19 Pandemic: Comparisons Between In-Person and Mail-Home Application. (opens in new tab)
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 | Zio | VisualDx |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2006 | 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.
