Lingo

[commercial]

biometric · food-service · 1 deployments in catalog

Field Advisory

Boundary INCLUDE (narrow) - glucose-biometric + adaptive insight layer: Glucose is in the biometric definition; Lingo is biometric-primary (interstitial glucose). It clears the medical-sensor-without-meaningful-AI exclusion bar on INSIGHT-LAYER substance: Lingo Count with adaptive targets, algorithm-driven personalized food-response recommendations, and Challenges are the differentiator vs a bare CGM graph (which Abbott deliberately does not sell to this wellness audience). Would it exist without the insight layer? Yes-and-meaningfully-degraded -> above the thin-AI floor. Second example of the GLUCOSE cell alongside Stelo., Cap-flag: NOT at Stelo parity (AI is adaptive/algorithmic, NOT verified generative): Critical distinction: Dexcom Stelo cleared the bar with a GENUINE generative-AI layer (Google Cloud Vertex AI + Gemini Weekly Insights). Lingo's primary sources describe adaptive / rule-based personalization only - no documented generative-AI layer, no 'Lingo Coach' AI agent (coaching is algorithmic plus human nutritionist via Lingo Live). Do NOT grant Lingo Stelo-equivalent AI standing. It passes on insight-layer substance, not on generative-AI grounds; this is the borderline case of the cohort and is flagged as such., FDA anchor: FDA 510(k) K233655 decided May 29 2024; OTC integrated CGM; adults 18+ not on insulin; explicitly not for diagnosis of any disease. Directly parallel to Stelo's OTC posture (Stelo = De Novo Mar 2024). Cleared via 510(k) (Stelo via De Novo) - both are OTC wellness clearances., Claimed but NOT verified: Any AI comparable to Stelo's generative AI (not verified - adaptive/rule-based only); a named 'Lingo Coach' AI agent (does not exist); exact stale tier table ($49/$89 figures - verified entry is ~$54/2-week, time-sensitive); any generative-AI roadmap for Lingo (none announced, unlike Dexcom).

Manufacturer

Abbott

Form Factor

biometric

Lifecycle

commercial

Operational Reality

Audited

Deployments

1

Target Price

$54 (actual sale price)

  • COMMERCIAL

Description

Lingo is Abbott's over-the-counter continuous glucose monitor biosensor for non-diabetic and wellness consumers, built on the FreeStyle Libre sensor platform, and it is recorded in the biometric form factor as a narrow boundary include and the second glucose example alongside Dexcom Stelo. Made by Abbott, listed on the New York Stock Exchange as ABT through its Abbott Diabetes Care unit, Lingo is a disposable biosensor worn on the back of the upper arm for up to fourteen days using a glucose-oxidase amperometric assay, and it was cleared by the FDA under 510(k) K233655 on May 29, 2024, as a Class II integrated continuous glucose monitoring system for adults eighteen and older who are not on insulin, explicitly not for the diagnosis of any disease including diabetes, a posture directly parallel to Stelo. Its app provides a real-time glucose graph, a Lingo Count daily glucose-spike metric with adaptive targets, food and activity logging, algorithm-driven personalized recommendations, Lingo Challenges behavioral nudges, and Lingo Live sessions with human Abbott nutritionists, with entry pricing of about fifty-four dollars for a two-week single-biosensor starter plan and recurring biweekly and monthly multi-sensor tiers. Glucose is in the biometric definition and Lingo is biometric-primary, and it clears the medical-sensor-without-meaningful-AI exclusion bar on insight-layer substance, since the Lingo Count, adaptive targets, and personalized food-response recommendations are the differentiator versus a bare continuous-glucose graph that Abbott deliberately does not sell to this wellness audience, so the device would exist without the insight layer only in a meaningfully degraded form. A critical cap-flag applies: Lingo is not at parity with Stelo on artificial intelligence. Stelo cleared the bar with a genuine generative-AI layer on Google Cloud Vertex AI and Gemini, whereas Lingo's primary sources describe adaptive and rule-based personalization only, with no documented generative-AI layer and no named AI coaching agent, its coaching being algorithmic plus human nutritionists through Lingo Live, so the registry does not grant Lingo Stelo-equivalent AI standing and records it as the borderline case of the cohort that passes on insight-layer substance rather than on generative-AI grounds. The FDA clearance is the strong anchor, and items not verified include any AI comparable to Stelo's generative AI, a named Lingo coaching agent, the older fifty-three-or-eighty-nine-dollar tier figures since the verified entry is about fifty-four dollars for two weeks and is time-sensitive, and any announced generative-AI roadmap for Lingo.

Key facts & specs

15 entries
website
https://abbott.mediaroom.com/2024-06-10-Abbott-Receives-FDA-Clearance-for-Two-Over-the-Counter-Continuous-Glucose-Monitoring-Systems
maturity
commercial
lifecycle
active
manufacturer
Abbott
deployments count
1
Maturity stage
commercial
Specs
Lingo: over-the-counter continuous glucose monitor (CGM) biosensor for non-diabetic / wellness consumers, built on Abbott's FreeStyle Libre sensor platform. Disposable biosensor worn on the back of the upper arm, up to 14-day wear, glucose-oxidase amperometric assay. FDA 510(k) K233655 decided May 29 2024 (announced Jun 10 2024); Class II integrated CGM (21 CFR 862.1355); indication: adults 18+ NOT on insulin; explicitly NOT for diagnosis of any disease including diabetes. App: real-time glucose graph, 'Lingo Count' daily glucose-spike metric with adaptive targets, food/activity logging, algorithm-driven personalized recommendations, 'Lingo Challenges' behavioral nudges, and 'Lingo Live' (free ~30-min sessions with human Abbott nutritionists). Pricing: entry ~$54 for a 2-week single-biosensor starter plan, recurring biweekly/monthly multi-sensor tiers. Maker: Abbott (NYSE: ABT), Abbott Diabetes Care.
Form Factor
biometric (biometric-primary GLUCOSE biosensor / OTC continuous glucose monitor + adaptive insight layer; second glucose example alongside Stelo)
Fda clearance
Source: https://www.fda.gov/medical-devices/recently-approved-devices/abbott-lingo-biosensor-k241163; Status: cleared; Details: FDA-cleared OTC biosensor (K241163, June 2024). General wellness use for tracking glucose, ketones, lactate. NOT indicated for diabetes management.; Audited at: 2026-06-07; Source name: FDA; Health claim: Metabolic tracking for wellness optimization. FDA-cleared but explicitly NOT a medical device for disease management.; Verification posture: verified
Runtime
up to 14 days
Price
~$54 for a 2-week single-biosensor starter plan
Sensor suite
glucose-oxidase amperometric assay
Autonomy level
FDA-cleared OTC Class II integrated CGM for adults 18+ not on insulin
Availability
Commercial — OTC, no prescription needed, abbott.com and pharmacies
Pricing model
Monthly subscription ($49/month for 2 sensors, 15-day wear each)

Availability and pricing

price
$54 (actual sale price) · as of 2024-06-10
lead time
Not disclosed
sales model
Not disclosed
availability
Shipping now
units in field
Not disclosed
pricing Model
Not disclosed

Safety record

Safety Status
Zero incidents on record

2 recalls on record (1 critical, 1 moderate). Most recent: May 2024.

Risk Metrics
Incidents: 0
Recalls: 2
Latest: May 2024
critical: 1
moderate: 1

FAQ

13 entries
What is Lingo?

Lingo is Abbott's over-the-counter continuous glucose monitor biosensor for non-diabetic and wellness consumers, built on the FreeStyle Libre sensor platform, and it is recorded in the biometric form factor as a narrow boundary include and the second glucose example alongside Dexcom Stelo. Made by Abbott, listed on the New York Stock Exchange as ABT through its Abbott Diabetes Care unit, Lingo is a disposable biosensor worn on the back of the upper arm for up to fourteen days using a glucose-oxidase amperometric assay, and it was cleared by the FDA under 510(k) K233655 on May 29, 2024, as a Class II integrated continuous glucose monitoring system for adults eighteen and older who are not on insulin, explicitly not for the diagnosis of any disease including diabetes, a posture directly parallel to Stelo. Its app provides a real-time glucose graph, a Lingo Count daily glucose-spike metric with adaptive targets, food and activity logging, algorithm-driven personalized recommendations, Lingo Challenges behavioral nudges, and Lingo Live sessions with human Abbott nutritionists, with entry pricing of about fifty-four dollars for a two-week single-biosensor starter plan and recurring biweekly and monthly multi-sensor tiers. Glucose is in the biometric definition and Lingo is biometric-primary, and it clears the medical-sensor-without-meaningful-AI exclusion bar on insight-layer substance, since the Lingo Count, adaptive targets, and personalized food-response recommendations are the differentiator versus a bare continuous-glucose graph that Abbott deliberately does not sell to this wellness audience, so the device would exist without the insight layer only in a meaningfully degraded form. A critical cap-flag applies: Lingo is not at parity with Stelo on artificial intelligence. Stelo cleared the bar with a genuine generative-AI layer on Google Cloud Vertex AI and Gemini, whereas Lingo's primary sources describe adaptive and rule-based personalization only, with no documented generative-AI layer and no named AI coaching agent, its coaching being algorithmic plus human nutritionists through Lingo Live, so the registry does not grant Lingo Stelo-equivalent AI standing and records it as the borderline case of the cohort that passes on insight-layer substance rather than on generative-AI grounds. The FDA clearance is the strong anchor, and items not verified include any AI comparable to Stelo's generative AI, a named Lingo coaching agent, the older fifty-three-or-eighty-nine-dollar tier figures since the verified entry is about fifty-four dollars for two weeks and is time-sensitive, and any announced generative-AI roadmap for Lingo.

How much does Lingo cost?

Lingo is listed at $54 on the DEPLOY registry. This is an actual sale price on record.

Is Lingo actually deployed in the real world?

Yes. Lingo 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.

Who makes Lingo?

Lingo is made by Abbott, based in Abbott Park, IL, founded in 1888.

Where is Lingo deployed?

1 verified deployment of Lingo is on the DEPLOY registry, including at Global.

Can you buy Lingo?

Lingo is available for purchase - a real sale price is on record (see the pricing section for the figure and its source).

Is Lingo FDA cleared?

Lingo has 2 regulatory records on the DEPLOY registry: FDA 510(k) clearance (K233655), cleared; FDA 510(k) clearance (K233655), cleared. See the Regulatory filings section for each agency source.

What are alternatives to Lingo?

On the DEPLOY registry, comparable biometric robots to Lingo include Blackrock Neuroport Array, BrainQ Non-Invasive BCI, Neko Body Scan, RNS System.

How does Lingo compare to Blackrock Neuroport Array?

Lingo and Blackrock Neuroport Array (Blackrock Neurotech · 5 deployments) are both biometric robots on the DEPLOY registry. Lingo has 1 verified deployment on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.

Is Lingo a top biometric?

On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Lingo ranks in roughly the top 78% of biometric models tracked by the registry.

What is Lingo's maturity stage?

Lingo 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 Lingo safe?

Lingo has 2 active incidents on record in the DEPLOY registry. 2 recalls on record (1 critical, 1 moderate). Most recent: May 2024. Retracted incidents are excluded from this count.

What is the Abbott Lingo glucose biosensor?

The Abbott Lingo is an over-the-counter (OTC) continuous glucose monitor (CGM) that attaches painlessly to the back of the upper arm. It can be worn for 14 days and tracks blood glucose levels with personalized, real-time insights via the accompanying app. FDA-cleared under 510(k) K233655.

Deployments

1 entry

Sectors & applications

1 entry