- No public price.
- Not disclosed
- Not disclosed
- —
- 2014
- US
Decision support
SimpleSense
by Nanowear · founded 2014 · US
Cloth wearable with 510(k) cleared AI cloud analytics for remote cardiac monitoring and cuffless blood pressure.
On this page
49/100
Editorial rating 3.5 / 5
- Regulatory & Compliance12/22
FDA cleared (4 K-numbers on record)
- Clinical Integration0/11.6
No EHR integrations listed
- Evidence Strength19.2/30
3 peer-reviewed papers
- Vendor & Market9/18
Founded 2014 (12 years)
- Sentiment & Transparency1.3/2.5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance12/12
FDA cleared (4 K-numbers on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- 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
- Peer-reviewed papers15/21
3 peer-reviewed papers
- RCT / meta-analysis / systematic review5/9
1 observational study (no RCT)
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market6/6
Founded 2014 (12 years)
- Pricing transparency1/3
Pricing on request, no public amounts
Cloth wearable with 510(k) cleared AI cloud analytics for remote cardiac monitoring and cuffless blood pressure.
No public price.
Evidence record
510(k)K232053 (opens in new tab)December 8, 2023
SimpleSense-BP, SimpleSense-BP Software Application
510(k)K212160 (opens in new tab)September 22, 2021
SimpleSENSE Platform
510(k)K201669 (opens in new tab)November 6, 2020
SimpleSENSE
510(k)K161431 (opens in new tab)November 30, 2016
SimplECG
3 studies on PubMed: 2 other, 1 observational, published 2022 to 2025. Read the literature summary
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, SimpleSense record, https://medaiverdict.com/tools/nanowear, version November 2, 2026
Bottom line
Nanowear, based in Brooklyn, makes a cloth garment with nanosensors and cloud analytics, SimpleSense, for home cardiometabolic assessment. The FDA's records show four 510(k) clearances between November 2016 and December 2023, the last for SimpleSense-BP, cuffless blood pressure software. The peer-reviewed validation with a described design is for blood pressure and has Nanowear authors. What the 2021 platform clearance covers for heart failure monitoring is not documented.
What are the four clearances?
The FDA record shows four 510(k) clearances, all substantial equivalence decisions, while the homepage says "FDA approved." K161431 (November 30, 2016) was for SimplECG, K201669 (November 6, 2020) for SimpleSENSE and K212160 (September 22, 2021) for the SimpleSENSE Platform. The latest, K232053 (December 8, 2023), is for SimpleSense-BP and its software application and names K212160 as its primary predicate.
What does the vendor say the garment does?
The vendor describes "a home-based AI digital diagnostic platform for cardiometabolic assessment, including congestive heart failure monitoring," with a cloth sensor garment that captures "more than 85 medical-grade biomarkers" from the skin and clinician and research portals on top. The homepage does not mention EHR integration, HIPAA or SOC 2.
What is the blood pressure evidence?
Lopez-Jimenez and colleagues in the Journal of Cardiovascular Translational Research, 2025 (PMID 39804564), report a prospective multicentre study of an AI-enabled cuffless blood pressure monitor in 303 subjects over 4 weeks, with a protocol "inspired by" ISO 81060-2 and IEEE 1708. Nanowear authors are among its writers, the validation was internal, and the authors ask for external validation. A 2022 Scientific Reports paper titled "Multiparametric cloth-based wearable, SimpleSense, estimates blood pressure" (PMID 35906364) also carries a Nanowear affiliation.
Company, funding and price
Nanowear Inc. is in Brooklyn, New York, and was founded in 2014 by Venk Varadan, CEO, and Vijay Varadan, CMO, according to a Glorikian interview. Funding sources disagree. Tracxn lists $1.52 million over two rounds starting with a seed on March 17, 2015, ZoomInfo says under $5 million in two rounds with the last closing on April 29, 2020, and MobiHealthNews reported $1.5 million led by Social+Capital in September 2014. No Series A is known, and no customer is named.
Nanowear does not publish a price.
The verdict
A program willing to evaluate a small vendor on cuffless blood pressure has a clearance and a validation with Nanowear authors to work from. For heart failure monitoring, a buyer has the K212160 clearance, whose scope is undocumented, and the vendor's own description.
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.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No public price. |
Source: vendor pricing page. Last checked November 2, 2026.
What deploys cleanly
Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
Who builds it
SimpleSense (Nanowear) was founded in 2014 in US, putting it 12 years into market.
What the literature says
3 peer-reviewed studies indexed on PubMed evaluate SimpleSense in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Multiparametric cloth-based wearable, SimpleSense, estimates blood pressure. (opens in new tab)
- Kumar PS, Rai P, Ramasamy M, et al.· Sci Rep· 2022
- Targeted maintenance of blood pressure for hypertensive patients requires accurate monitoring of blood pressure at home. Use of multiparametric vital signs ECG, heart sounds, and thoracic impedance for blood pressure estimation at home has not been reported previously. In an observational multi-site study, 120 subjects (female (N = 61, 52%)) between 18 and 83 years of age were recruited with the following stratification (Normal (20%), prehypertensive (37%), stage 1(26%), and stage 2 (18%). From these subjects, 1686 measurements of blood pressure from a sphygmomanometer were…
- 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)
- Lopez-Jimenez F, Deshmukh A, Bisognano J, et al.· J Cardiovasc Transl Res· 2025
- Non-invasive, continuous blood pressure monitoring technologies require additional validation beyond standard cuff-based methods. This study evaluates a non-invasive, multiparametric wearable cuffless blood pressure (BP) diagnostic monitor across all hypertension classes with diverse subjects. A prospective, multicenter study assessed Nanowear's SimpleSense-BP performance, including induced and natural BP changes, significant BP variations (Systolic BP (SBP) ≥ ± 15 mm Hg and Diastolic BP (DBP) ≥ ± 10 mm Hg), and reference input value validit…
- Nanotechnology and Artificial Intelligence: An Emerging Paradigm for Postoperative Patient Care. (opens in new tab)
- Del Vecchio D, Stein MJ, Dayan E, et al.· Aesthet Surg J· 2023
- An increasing number of aesthetic surgery procedures are being performed in an ambulatory fashion in office-based settings. Postoperative monitoring of these patients has historically required paid private-duty nurses measuring vital signs, encouraging ambulation, and monitoring overall comfort level. Recently, advancements in nanotechnology have permitted high-acuity data acquisition of multiple clinical parameters that can be transmitted to the surgeon's mobile device in a continuous fashion. The aim of this study was to describe the authors' early experience with this emerging artificial i…
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