Zio vs SimpleSense
A cardiology practice can weigh these two together, since each sells remote cardiac monitoring. Zio from iRhythm is an ECG patch with cloud analysis, technician review and a physician report, backed by 18 FDA decisions, the Zio monitor on August 15, 2025 among them, and an FDA warning letter dated May 25, 2023.
Nanowear's SimpleSense is a cloth garment that the vendor describes as a home-based platform for cardiometabolic assessment, including heart failure monitoring. Its four 510(k) decisions run from SimplECG in 2016 to SimpleSense-BP, for cuffless blood pressure, on December 8, 2023. A 2025 prospective multicentre study of 303 subjects by Nanowear authors was an internal validation, and the authors ask for external validation. Funding figures conflict: Tracxn lists USD 1.52M over two rounds, ZoomInfo says under USD 5M in two rounds with the last closing April 29, 2020, and MobiHealthNews reported USD 1.5M in September 2014.
For a practice ordering ambulatory arrhythmia monitoring, Nanowear trails iRhythm, because Zio is described as arrhythmia detection with a physician report and SimpleSense as cardiometabolic assessment. A heart failure program wanting garment-based readings at home fits Nanowear.
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.

SimpleSense
by Nanowear · founded 2014
Cloth wearable with 510(k) cleared AI cloud analytics for remote cardiac monitoring and cuffless blood pressure.
When to pick each one
Zio
- Ambulatory arrhythmia monitoring with physician reports
- Vendor: deep-learned algorithm verified by cardiac technicians
SimpleSense
- Cloth garment for home heart failure monitoring
- Cuffless blood pressure, K232053 in December 2023
- Four 510(k) decisions since 2016
Score
Each row shows points earned of points available under the published rubric.
Zio
69of 100
SimpleSense
49of 100
| Dimension | Zio | SimpleSense | Difference |
|---|---|---|---|
| FDA clearance | 12 / 12 | 12 / 12 | 0 |
| 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 | 4.5 / 9 | +4.5 |
| Funding & adoption signal | 8.4 / 12 | 3 / 12 | +5.4 |
| Pricing transparency | 1.3 / 2.5 | 1.3 / 2.5 | 0 |
| 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. |
SimpleSense
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
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)
SimpleSense
FDA decisions
K232053 (opens in new tab)510(k)2023-12-08
SimpleSense-BP, SimpleSense-BP Software Application
K212160 (opens in new tab)510(k)2021-09-22
SimpleSENSE Platform
K201669 (opens in new tab)510(k)2020-11-06
SimpleSENSE
K161431 (opens in new tab)510(k)2016-11-30
SimplECG
Peer-reviewed
3 PubMed records name SimpleSense.
- Multiparametric cloth-based wearable, SimpleSense, estimates blood pressure. (opens in new tab)
- Development and Internal Validation of an AI-Enabled Cuff-less, Non-invasive Continuous Blood Pressure Monitor Across All Classes of Hypertension. (opens in new tab)
- Nanotechnology and Artificial Intelligence: An Emerging Paradigm for Postoperative Patient Care. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Zio | SimpleSense |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2006 | 2014 |
| 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.
