Biolinq
Biolinq is a San Diego-based medical device company developing Biolinq Shine, an FDA-cleared (De Novo, September 2025) needle-free, intradermal continuous glucose monitor with an integrated LED display, targeting adults with Type 2 diabetes not on insulin and health-conscious consumers through OTC and direct-to-consumer channels.
- Company typePrivate
- Founded2012
- HeadquartersSan Diego, United States
- Headcount51–100
- GTM typeB2C
- OfferingHardware or Manufacturing
What Biolinq does
Biolinq Incorporated is a San Diego-based healthcare technology company founded in 2012 that has developed an intradermal wearable biosensor platform. Its flagship product, Biolinq Shine, is a needle-free continuous glucose monitor whose microsensor array sits approximately 0.2 mm below the skin surface in the papillary dermis — roughly 20 times shallower than conventional CGM sensors — and is manufactured using semiconductor processes. The device integrates glucose sensing with an accelerometer and ambient light sensor, displays real-time glucose status via a color-coded LED (blue for in-range, yellow for elevated), and pairs with a mobile app that correlates glucose with meals, rest, and activity. On September 25, 2025, the FDA granted De Novo Classification for Biolinq Shine for over-the-counter use in adults 22 and older with Type 2 diabetes not on insulin therapy, establishing a new regulatory category for autonomous, needle-free glucose sensors with integrated primary displays.
The company is preparing to commercialize the device primarily through direct-to-consumer e-commerce and pharmacy retail channels, with an initial focus on people with Type 2 diabetes not on insulin and a secondary target of health-conscious consumers seeking metabolic and lifestyle insight. Revenue mechanics are expected to follow a hardware-plus-disposable model with recurring sensor replacement cycles, although pricing has not been publicly disclosed. The platform is architecturally designed for multi-analyte expansion to additional biomarkers such as lactate and cortisol.
Biolinq has raised approximately $300 million across multiple funding rounds (Series A in 2017, Series B in 2021, bridge financing in 2024, and Series C in April 2025), with Alpha Wave Ventures leading the most recent two rounds. The management team is dominated by former Dexcom and Medtronic Diabetes executives, and the board includes representatives from Alpha Wave Ventures, AXA IM Alts, RiverVest Venture Partners, and UnitedHealthcare.
Biolinq firmographics
Firmographics- Name
- Biolinq
- Legal name
- Biolinq Incorporated
- Website
- https://biolinq.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Biolinq is a San Diego-based medical device company developing Biolinq Shine, an FDA-cleared (De Novo, September 2025) needle-free, intradermal continuous glucose monitor with an integrated LED display, targeting adults with Type 2 diabetes not on insulin and health-conscious consumers through OTC and direct-to-consumer channels.
- Ownership category
- akta.pro rank
Biolinq industry classification
Industry- Product category
- Wearable Continuous Glucose Monitoring
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Other Measuring and Controlling Device Manufacturing (334519), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845), In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Continuous Glucose Monitoring (CGM) Systems (HLAHAHAA)
- akta.pro secondary industries
- Blood Glucose Monitoring Devices (Consumer CGM & Smart Glucometers) (CRACAQAE), Diabetes Care Device Accessories & Adhesives (Sensors/Pump Supplies) (HLAHAHAL), Biosensors & Lab-on-Chip (BioMEMS) (HDAHALAK)
Keywords
Where Biolinq is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Biolinq business model
Business model- GTM type
- B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Operations, Marketing or Sales, Infrastructure
Revenue model
- Biolinq Shine Glucose Sensor: Wearable biosensor sold as a disposable device with continuous glucose monitoring capability. Revenue expected from device sales, likely with recurring disposable sensor replacement cycle. Initially targeted at adults with Type 2 diabetes not on insulin therapy.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
Biolinq product offering
Product offeringCore offering
Biolinq develops and commercializes the Biolinq Shine, a needle-free wearable continuous glucose monitoring (CGM) biosensor. The device uses an intradermal electrochemical microsensor array positioned in the papillary dermis layer (approximately 0.2mm deep, 20x more shallow than conventional CGM sensors) to measure glucose from interstitial fluid without hypodermic needles. It integrates a color-coded LED display (blue/yellow) for real-time glucose status and automatically correlates glucose data with activity and sleep tracking. The product received FDA De Novo classification in September 2025, establishing a new regulatory category of autonomous wearable glucose sensors.
Product overview
Biolinq is a healthcare technology company pioneering precision multi-analyte wearable biosensors to improve metabolic health. The company's flagship product is the Biolinq Shine biosensor, a needle-free continuous glucose monitoring wearable that integrates glucose, activity, and sleep data in a single device. The system consists of the Biolinq Shine hardware sensor with an autonomous LED display and a companion mobile application that provides detailed trend analysis and personalized insights. The platform is designed for multi-analyte sensing expansion beyond glucose to include biomarkers such as lactate and cortisol.
Differentiator
Problem solved
Functional benefit
Brands
- Biolinq Shine: First fully autonomous, needle-free glucose sensor with integrated LED display for real-time glucose feedback, combining glucose, activity, and sleep monitoring in a single device for people with Type 2 diabetes not on insulin therapy.
Products and services
- Biolinq Shine A needle-free wearable biosensor that continuously monitors glucose levels using an array of microsensors up to 20 times more shallow than conventional continuous glucose sensors. Features an integrated LED color-coded display (blue for in-range, yellow for elevated) visible without a phone, and automatically tracks activity and sleep data. Designed for adults 22 years or older with type 2 diabetes not on insulin therapy.
Quantifiable outcome
- First needle-free glucose sensor with integrated primary display receiving FDA De Novo classification
- +2 more outcomes
Companies that use Biolinq
Customer profileSegments2 records
Ideal customer profiles2 records
Biolinq technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
Feature4 records
Biolinq partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Amalgam RxcoreAmalgam Rx partnered with Biolinq to develop digital infrastructure for Biolinq Shine. Amalgam's platform enabled rapid software development supporting Biolinq's FDA regulatory process and future expansion plans for connected health solutions and personalized care.
Scale indicators6 records
Recent moves6 records
Expansion highlights5 records
Biolinq competitors and assessment
Company assessmentDirect peers
- Dexcom: Dexcom is the U.S. market leader in continuous glucose monitoring, offering G6 and G7 CGM systems. Directly comparable as a CGM device maker targeting diabetes patients with needle-based wearable sensors, though serving broader populations including insulin-dependent users.
- Abbott (FreeStyle Libre): Abbott's FreeStyle Libre is the global volume leader in CGM with factory-calibrated sensors. Direct competitor in the wearable glucose monitoring category, with a substantial non-insulin T2D user base that Biolinq also targets.
- Senseonics: Senseonics develops Eversense, the first long-term implantable CGM with a 180-day sensor. Direct peer pursuing an alternative-format CGM approach with extended wear time, competing for differentiated glucose monitoring share.
Broad incumbents
- Medtronic: Medtronic offers the Guardian CGM system integrated with its insulin pumps and closed-loop diabetes management portfolio. Broad incumbent in diabetes devices; former employer of Biolinq CEO Rich Yang.
- Ascensia Diabetes Care: Ascensia is a focused diabetes care company offering CONTOUR blood glucose monitoring systems. A Series B investor in Biolinq and a broad incumbent in the diabetes monitoring category.
- Insulet: Insulet makes the Omnipod tubeless insulin pump, an adjacent diabetes management device. Broad incumbent in diabetes care delivery with potential ecosystem overlap with CGM data.
- Tandem Diabetes Care: Tandem develops the t:slim insulin pump with CGM integration for automated insulin delivery. Broad incumbent in diabetes management and a potential integration partner for Biolinq's data streams.
- Roche Diabetes Care: Roche offers the Accu-Chek portfolio of blood glucose monitors and insulin delivery systems. Broad incumbent in diabetes monitoring with established pharmacy and payer channels relevant to Biolinq's OTC strategy.
Emerging players
- Nemaura Medical: Nemaura is developing sugarBEAT, a non-invasive continuous glucose monitor using a skin patch. Emerging player pursuing needle-free CGM with partial overlap to Biolinq's needle-free approach.
- EOFlow: EOFlow develops the EOPatch tubeless insulin pump and participated as an investor in Biolinq's Series B. Emerging player in wearable drug delivery with potential ecosystem partnership in diabetes care.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
Biolinq social profiles
Digital presenceBiolinq compliance and trust
Trust signalCompliance1 record
Biolinq financial estimates
Financial estimateRevenue estimate
Valuation estimate
Biolinq leadership team
Management profileNumber of profiles
Profiles18 records
Biolinq funding detail
Funding detailFunding overview
Funding rounds9 records
Investors29 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Biolinq M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Biolinq
What does Biolinq do?
Biolinq develops and commercializes the Biolinq Shine, a needle-free wearable continuous glucose monitoring (CGM) biosensor. The device uses an intradermal electrochemical microsensor array positioned in the papillary dermis layer (approximately 0.2mm deep, 20x more shallow than conventional CGM sensors) to measure glucose from interstitial fluid without hypodermic needles. It integrates a color-coded LED display (blue/yellow) for real-time glucose status and automatically correlates glucose data with activity and sleep tracking. The product received FDA De Novo classification in September 2025, establishing a new regulatory category of autonomous wearable glucose sensors.
Is Biolinq a public or private company?
Biolinq is a private company. It is classified as venture growth investor backed and is currently operating.
When was Biolinq founded?
Biolinq was founded in 2012. It employs 51 to 100 people.
Where is Biolinq based?
Biolinq is headquartered in San Diego, United States, in the North America region.
How does Biolinq make money?
One revenue line is on record: biolinq Shine Glucose Sensor.
Who are Biolinq's main competitors?
Direct peers on record are Dexcom, Abbott (FreeStyle Libre) and Senseonics. Broad incumbents are Medtronic, Ascensia Diabetes Care, Insulet, Tandem Diabetes Care and Roche Diabetes Care. Emerging players are Nemaura Medical and EOFlow.
Does Biolinq have an API?
No public API is recorded for Biolinq.
What industry is Biolinq in?
Biolinq's product category is Wearable Continuous Glucose Monitoring. Its primary akta.pro industry code is HLAHAHAA, Continuous Glucose Monitoring (CGM) Systems, with a secondary code of CRACAQAE, Blood Glucose Monitoring Devices (Consumer CGM & Smart Glucometers). Its NAICS code is 334510 and its SIC code is 3841.