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Robot model

Stelo

biometriccommercialby Dexcom
$89verifiedas of Aug 2024

Stelo by Dexcom is a continuous glucose monitor biosensor and the glucose-biometric entry in the cohort, recorded in the biometric form factor as a boundary…

Track Stelo
Manufacturer
Dexcom
Form factor
biometric
Maturity
commercial
Lifecycle
active
Deployments
2
Website
investors.dexcom.com ↗

The verified answer

As of Sep 2026, DEPLOY verifies Stelo, a biometric by Dexcom (commercial): 2 verified deployments on record. 5 sources back the record.

Regulatory status2 FDA 510(k) clearances

Stelo holds 2 FDA 510(k) clearances, per the DEPLOY registry.

See all 2 filings

Overview

Stelo by Dexcom is a continuous glucose monitor biosensor and the glucose-biometric entry in the cohort, recorded in the biometric form factor as a boundary include because glucose is in the biometric definition and Stelo pairs an FDA-cleared sensor with a genuine generative-AI insight layer rather than being a bare sensor readout. Made by DexCom (NASDAQ: DXCM) as a product line separate from its prescription G7 monitors, Stelo is the first-ever FDA-cleared over-the-counter, no-prescription continuous glucose biosensor, cleared via De Novo announced on March 5, 2024 and launched in the US on August 26, 2024 for adults 18 and older who are not on insulin, including people with type 2 diabetes not on insulin and non-diabetic users tracking the impact of diet and exercise, with a 15-day wear and no low-glucose alerts since it is not cleared for problematic hypoglycemia.

Its AI augmentation is genuine: Dexcom launched a generative-AI platform for Stelo on Google Cloud's Vertex AI and Gemini, providing personalized Weekly Insights, AI photo meal logging, and up to three personalized daily recommendations drawn from glucose, activity, nutrition, and sleep, which is what tips it from a medical sensor to an in-definition biometric-AI device and fills the glucose cell distinct from the heart-rate and sleep watches and rings. Its FDA clearance makes it the strongest verification anchor of the Wave-2 set, while the marketing claim of being the first generative-AI platform in glucose biosensing is not load-bearing and is not asserted, and its exclusion of low-glucose alerting is recorded as an indication boundary.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Sources on file
View all sources →

Key facts

Wear duration

15-day wear

FDA clearance date

March 5, 2024

US launch date

August 26, 2024

Target users

Adults 18+ not on insulin

AI platform

Google Cloud Vertex AI + Gemini

Price

$99.99/month (2 sensors/month, 15-day wear each) — subscription via dexcom.com

Pricing model

Subscription: $99.99/month or $89.99/month with annual plan

Availability

Commercial — OTC, no prescription needed, dexcom.com and pharmacies

Form factor

Wearable CGM biosensor patch (over-the-counter)

Specs

Notes

Boundary INCLUDE (glucose-biometric + real AI): Glucose is in the biometric definition; Stelo clears the medical-sensor-without-meaningful-AI exclusion bar: it pairs an FDA-cleared glucose biosensor with a GENUINE generative-AI insight layer (Vertex AI/Gemini Weekly Insights, AI meal photo logging, personalized recommendations from glucose/activity/nutrition/sleep) - not a bare sensor readout. Fills the GLUCOSE cell of the biometric cohort (distinct from the HR/sleep watches+rings)., FDA status (strongest anchor in Wave 2): First-ever FDA-cleared OTC (no-prescription) continuous glucose biosensor: De Novo clearance announced Mar 5 2024; US launch Aug 26 2024; for adults 18+ not on insulin. The FDA clearance makes it the strongest verification anchor of the Wave-2 set., Cap-flag: 'First generative AI platform in glucose biosensing' is Dexcom marketing framing - the CLEARANCE and the Vertex/Gemini integration are verified; the 'first' superlative is not load-bearing, don't assert it. Stelo is NOT cleared for problematic hypoglycemia / no low-glucose alerts (an indication boundary)., Source/methodology (Phase 1A, 2026-06-04): Primary-FDA source added. Pathway cap-flag (verified-vs-claimed discrepancy): the FDA 510(k) database lists Stelo as K234070, a 510(k) (substantially-equivalent), whereas much coverage and the prior record framing described the clearance as De Novo. 'First OTC glucose biosensor' is a market-status claim that stands. The accessdata 510(k) record is the authoritative regulatory pathway; flagged here rather than force-rewriting the prose pending reconciliation.

Specs

Stelo: continuous glucose monitor (CGM) biosensor, 15-day wear; first-ever FDA-cleared OTC (no-prescription) glucose biosensor (De Novo Mar 5 2024; US launch Aug 26 2024). Indication: adults 18+ NOT on insulin (type 2 not on insulin + non-diabetic users tracking diet/exercise impact); not cleared for problematic hypoglycemia (no low-glucose alerts). Generative-AI: Weekly Insights (Google Cloud Vertex AI + Gemini), AI photo meal logging, personalized daily recommendations. Company: DexCom Inc (NASDAQ: DXCM); Stelo = the OTC product line (separate from prescription G7).

Battery

15 days

Weight kg

0.005

Form Factor

biometric (biometric-primary GLUCOSE biosensor / OTC continuous glucose monitor + generative-AI insights)

Fda clearance

Source: fda.gov Status: cleared; Details: FDA-cleared OTC CGM (K232990, March 2024). First over-the-counter continuous glucose monitor without prescription. For non-insulin users aged 18+.; Audited at: 2026-06-07; Source name: FDA; Health claim: Glucose monitoring for Type 2 diabetes management and general metabolic awareness. FDA-cleared medical device.; Verification posture: verified

Data & sources

Press releases

3

News coverage

1

Government records

1

5 sources backing this record.View all →

Availability and pricing

Availability
Shipping now
Price
$89 to $99 (actual sale price)as of 2024-08-26
Units in field
Not disclosed
Sales model
Not disclosed
Lead time
Not disclosed

Pricing

One-time purchase

$89 - $99 USDactual sale priceas of 2024-08-26

Source: DexCom (Stelo)

Price status: actual-sale-price = real published price at time of sale; manufacturer-target = vendor target, not yet realized; analyst-estimate = third-party projection, not a vendor figure; not-announced = no price on record.

Prices verified as of Aug 26, 2024

Deployments (2)

  • Stelo at United Kingdomannounced

    Dexcom announced plans to introduce Stelo CGM biosensor internationally beginning later in 2026, with launches expected through 2027 in the UK, Australia, New Zealand, and South Korea.

  • Stelo at Globaloperational

    The Stelo is an over-the-counter continuous glucose biosensor that received FDA authorization in March 2024 as the first OTC continuous glucose monitor, operated by Dexcom in San Diego.

Free to use on your site, with a link back to DEPLOY.

Stelo on the deployment map

View the global map

Where Stelo is verified operating. Explore the deployment map by place and type.

Free to use on your site, with a link back to DEPLOY.

Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

Full change history →

Deployment-verified media (1)

PRIMARY SOURCE
Courtesy of Dexcom

Dexcom's getting-started guide for Stelo, its over-the-counter glucose biosensor. Stelo is FDA-cleared as the first OTC integrated continuous glucose monitor (2024), for wellness and metabolic-health users not on insulin, distinct from the prescription Dexcom G7.

From deployment: Global

Regulatory filings (2)

Safety record

No incidents on record for Stelo.

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Sources (5)

  1. https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter/default.aspx
  2. https://investors.dexcom.com/news/news-details/2024/Dexcom-Launches-the-First-Generative-AI-Platform-in-Glucose-Biosensing/default.aspx
  3. https://www.medtechdive.com/news/dexcom-gen-ai-feature-stelo-cgm/735918/
  4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234070
  5. https://www.stelo.com/en-us/buy-stelo-one-time

Compare Stelo

Common questions

What is Stelo?
Stelo by Dexcom is a continuous glucose monitor biosensor and the glucose-biometric entry in the cohort, recorded in the biometric form factor as a boundary include because glucose is in the biometric definition and Stelo pairs an FDA-cleared sensor with a genuine generative-AI insight layer rather than being a bare sensor readout. Made by DexCom (NASDAQ: DXCM) as a product line separate from its prescription G7 monitors, Stelo is the first-ever FDA-cleared over-the-counter, no-prescription continuous glucose biosensor, cleared via De Novo announced on March 5, 2024 and launched in the US on August 26, 2024 for adults 18 and older who are not on insulin, including people with type 2 diabetes not on insulin and non-diabetic users tracking the impact of diet and exercise, with a 15-day wear and no low-glucose alerts since it is not cleared for problematic hypoglycemia. Its AI augmentation is genuine: Dexcom launched a generative-AI platform for Stelo on Google Cloud's Vertex AI and Gemini, providing personalized Weekly Insights, AI photo meal logging, and up to three personalized daily recommendations drawn from glucose, activity, nutrition, and sleep, which is what tips it from a medical sensor to an in-definition biometric-AI device and fills the glucose cell distinct from the heart-rate and sleep watches and rings. Its FDA clearance makes it the strongest verification anchor of the Wave-2 set, while the marketing claim of being the first generative-AI platform in glucose biosensing is not load-bearing and is not asserted, and its exclusion of low-glucose alerting is recorded as an indication boundary.
How much does Stelo cost?
Stelo is listed at $89 to $99 on the DEPLOY registry. This is an actual sale price on record.
DexCom (Stelo)
Is Stelo actually deployed in the real world?
Yes. Stelo is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.
What are the specs of Stelo?
Stelo's recorded specifications on the DEPLOY registry: Battery: 15 days; Weight: 0.005 kg. See the Specs section for the full sourced set.
Who makes Stelo?
Stelo is made by Dexcom, based in San Diego, California, USA, founded in 1999.
Where is Stelo deployed?
2 verified deployments of Stelo are on the DEPLOY registry, including at United Kingdom, Global.
Can you buy Stelo?
Stelo is available for purchase - a real sale price is on record (see the pricing section for the figure and its source).
Is Stelo FDA cleared?
Stelo has 2 regulatory records on the DEPLOY registry: FDA 510(k) clearance (K234070), cleared; FDA 510(k) clearance (K234070), cleared. See the Regulatory filings section for each agency source.
What are alternatives to Stelo?
On the DEPLOY registry, comparable biometric robots to Stelo include Blackrock Neuroport Array, BrainQ Non-Invasive BCI, Neko Body Scan, RNS System.
How does Stelo compare to Blackrock Neuroport Array?
Stelo and Blackrock Neuroport Array (Blackrock Neurotech · 5 deployments) are both biometric robots on the DEPLOY registry. Stelo has 2 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.
Is Stelo a top biometric?
On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Stelo ranks in roughly the top 17% of biometric models tracked by the registry.
What is Stelo's maturity stage?
Stelo is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.
Is Stelo safe?
Stelo has no incidents on record in the DEPLOY registry. This does not constitute a safety guarantee; it reflects the incidents DEPLOY has tracked and verified to date.
What is the Stelo glucose biosensor?
Stelo is a non-prescription over-the-counter (OTC) glucose biosensor by Dexcom that tracks glucose 24/7. It is an integrated Continuous Glucose Monitor (iCGM) suitable for adults (18+ years) not on insulin. FDA-cleared under 510(k) K234070. No prescription required.
Stelo: Wearable glucose biosensor Dexcom: G7 CGM and Stelo
Methodology: Verified · 5 sources (4 primary) · last reviewed 2026-07-18

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-18

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: biometric

Sub-cohorts: glucose-cell-ai-substance-gradient

Sources by quality tier

3
primary-company-ir
Company IR disclosure
1
secondary-trade-publication
Trade publication
1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Stelo.

Recent coverage

Stelo in third-party press

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Jun 15, 2026

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Jan 15, 2026

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Jan 1, 2025