COMPANY PROFILE / BIOSENSORS
i-SENS
A Korean electrochemical biosensor company that makes glucose test strips for other brands around the world is now taking its own continuous glucose monitor, CareSens Air, abroad
i-SENS comes up in any discussion of biosensors because it has a capacity of about 1.7 billion blood glucose test strips a year, sells them both under its own brands and for other companies' brands (ODM and OEM), and launched its own continuous glucose monitor (CGM), CareSens Air, in 2023. According to its 2025 annual report (consolidated), revenue was KRW 315,445 million (up 8.3%), about 80% of it exported. In February 2026 the U.S. company LifeScan announced a partnership under which i-SENS technology and manufacturing will be used for a OneTouch Vita-branded continuous glucose monitor in Europe. This profile sets out, from Korea's electronic disclosure system (DART), company materials and FDA public documents, how much the company invests in test strips and CGM, where it sells, and what authorizations it holds.
- i-SENS in 30 seconds, and where it stands in biosensors
- The logo and how the name is written
- Where the company sits in the field
- Scale
- Resources committed to biosensors
- What it has done so far
- What comes next
- What the company is aiming for in biosensors
- Map of partnerships in biosensors
- Technologies, products and services
- The risks this company carries
- Glossary, references and claim-to-source audit
1. i-SENS in 30 seconds, and where it stands in biosensors
(secondary: IVD & POCT)Blood glucose meters and strips are the core; CGM is a new pillar
strips and CGM sensorsThe CGM uses a GDH-FAD enzyme and electrochemistry, with 15-day wear (company manual)
i-SENS is better understood as a manufacturer that also makes blood glucose test strips for other companies' brands around the world than as a new company selling its own CGM. The annual report lists its own brands (CareSens, CareSens Air, NoCoding1, A1Care), ODM brands (ReliOn Premier, BGStar, Barozen) and an OEM line (Ai-Sensor), and it discloses Arkray, Inc. as its largest customer (about 14.8% of 2025 consolidated revenue; our calculation) Sourced. It launched its CGM under its own brand in September 2023, and in February 2026 announced a partnership with LifeScan (OneTouch Vita brand, with launch in Germany, Ireland, Portugal and Belgium expected by early 2027) Not yet confirmed. CGM revenue alone does not appear separately in the annual report, and an i-SENS CGM could not be found in the FDA database.
2. The logo and how the name is written
A note on names: the legal entity is i-SENS, Inc., and the hyphen and capitals are the official form. CareSens (blood glucose meters), CareSens Air (CGM), A1Care (HbA1c), i-Smart (electrolytes and blood gases) and Coag-Sense (coagulation) are product and brand names. ReliOn Premier, BGStar and Barozen are other companies' brands, names of products that i-SENS makes under contract (the brand owners are not identified in the materials we reviewed). AgaMatrix, CoaguSense and i-SENS USA are subsidiaries. The logo is the wordmark with green dots used on the company's official website (i-sens.com).
Official site: https://i-sens.com/3. Where the company sits in the field
4. Scale
The main consolidated figures are below (Korean IFRS, in KRW million; no currency conversion is made) Sourced.
| Measure (KRW million) | 2023 | 2024 | 2025 | First half of 2026 |
|---|---|---|---|---|
| Revenue | 265,120 | 291,138 | 315,445 | 163,804 |
| Operating profit | 10,929 | 2,658 | 7,887 | 7,545 |
| Net income | 3,404 | -1,953 | -6,690 | 5,571 |
| R&D expense | 27,661 | 30,999 | 33,124 | 20,707 |
| R&D as a share of revenue | 10.4% | 10.6% | 10.5% | 12.6% |
For the higher 2025 operating profit the company cites higher continuous glucose monitor sales and better results at overseas subsidiaries. We did not confirm the reasons behind the net loss. The 2025 revenue breakdown is meters, strips and HbA1c instruments and others KRW 255,909 million (81.1%), electrolyte and blood gas analyzers and cartridges 18,954 (6.0%), coagulation instruments and strips 19,055 (6.0%), goods (meters and connectors) 18,987 (6.0%) and other 2,540 (0.9%). Exports were 247,034 (about 78.3%; our calculation), and by customer location the figures are United States 99,830, Korea 66,826, Europe 48,152, Asia 45,096 and other 55,541.
| Key customer and product measures | 2024 | 2025 | The company's description |
|---|---|---|---|
| Sales to Arkray, Inc. (KRW million) | 51,108 | 46,671 | Disclosed as a major customer. About 14.8% of 2025 consolidated revenue (our calculation). The nature of the business is not described |
| Blood glucose strips produced (units) | 1,755,896,750 | 1,668,042,000 | Annual capacity 1.72 billion; utilization 96.9% (2025) |
| Continuous glucose monitors produced (units) | 183,570 | 563,598 | Annual capacity 2 million; utilization 28.2% (2025). Production in the first half of 2026 was 563,216 |
The annual report does not disclose CGM revenue alone. A company release of October 2025 says CGM sales were KRW 6.0 billion for full-year 2024 and KRW 6.7 billion in the first half of 2025 (up 88% year on year). These are company announcements, separate from the consolidated revenue breakdown in the annual report Not yet confirmed.
5. Resources committed to biosensors
| Resource | What primary sources confirm | Status |
|---|---|---|
| People | The filing company alone had 957 employees at the end of 2025 (579 men and 378 women) and 997 at the end of June 2026. R&D is organized in three institutes and 12 teams: the Sensor Institute (5 teams: strips, electrolyte and blood gas cartridges, HbA1c and immunosensors), the Device Institute (5 teams) and the CGMS Institute (2 teams: CGM sensor development and CGM data management). CGM-specific headcount is not disclosed | Sourced / partly undisclosed |
| Money (R&D) | KRW 33,124 million in 2025 (10.5% of revenue) and KRW 20,707 million in the first half of 2026 (12.6%). These are before government subsidies, which were KRW 476 million in 2025, 737 million in 2024 and 666 million in 2023. CGM-specific R&D is not disclosed | Sourced / partly undisclosed |
| Money (capital spending) | Property, plant and equipment additions were KRW 23,052 million in 2025 (production facility table). For the Songdo (Incheon) second plant, land and buildings of KRW 66,500 million have been invested. CGM production equipment is planned at KRW 33,910 million in total, of which 11,510 million is already invested, with the rest given as 3,000 million for the 26th period, 10,000 million for the 27th and 9,400 million for the 28th and later. Commitments under an entry agreement for the Magok industrial complex in Seoul stood at KRW 12,044 million at the end of June 2026 | Sourced / Not yet confirmed (plan) |
| Acquisitions, investments, divestitures | AgaMatrix, Inc. (U.S.; acquired 10 July 2023; 100% owned; acquisition cost KRW 37,437 million) and CoaguSense, Inc. (U.S.; acquired in 2016; 75.3% owned). The company also has 12 consolidated subsidiaries, 10 investments with management participation and 11 simple investments. In April 2024 it issued KRW 50,000 million of private convertible bonds (maturing 2029), part of which converted to shares in 2026. No divestiture was found | Sourced |
| Universities, research institutes, public funding | Government R&D subsidies (above). Designated an "Innovative Medical Device Company" by the Ministry of Health and Welfare in December 2020 (company history). In December 2025 it co-hosted a CareSens Air symposium with the Korean Association of Diabetes Nurse Educators (about 40 participants). No specific university collaboration or public grant project name could be found | Sourced / partly not found |
Regulatory status (as far as could be confirmed)
| Product | Intended use | Category | Date | Source |
|---|---|---|---|---|
| CareSens N Premier (blood glucose meter) | Quantitative measurement of glucose in fresh capillary whole blood from the fingertip; self-testing at home by people with diabetes (over the counter, OTC). Not for neonates or for diagnosis or screening of diabetes | FDA 510(k) clearance (K170614; product code NBW) | 19 October 2017 | Reference 14 |
| ReliOn Premier BLU (ODM product) | Same (fingertip capillary whole blood, self-testing, OTC) | FDA 510(k) clearance (K230625; the applicant is I-Sens, Inc.) | 10 August 2023 | Reference 15 |
| Other meters and ketone meters | CareSens N Feliz (K201394, 5 October 2021), CareSens S Clear BT (K192859, 24 January 2020), KetoSens (beta-ketone; K170463, 13 April 2018) and others. There are 27 FDA 510(k) records with I-Sens, Inc. as applicant (2008-2023) | FDA 510(k) clearance | 2008-2023 | Reference 13 |
| AgaMatrix (subsidiary) meters | WaveSense Jazz (K241304) and others | FDA 510(k) clearance | 6 June 2024 | Reference 16 |
| CareSens Air (CGM) | Continuous measurement of glucose in interstitial fluid. People with diabetes aged 18 and older. The manual says it is intended to replace standard blood glucose testing for treatment decisions unless otherwise indicated. Not evaluated or approved for pregnant or breastfeeding women, people on dialysis or critically ill patients | Europe: CE mark (the company says the upgraded version was approved on 25 March 2025; the EU authorised representative is a German company). Korea: launched in September 2023 (company history). U.S.: not found in the FDA database. Japan: could not be confirmed | September 2023 (Korean launch) / 25 March 2025 (CE for the upgrade) | References 3, 7, 10 |
An FDA "510(k) clearance" recognizes substantial equivalence to a device already on the market. It is different from "De Novo authorization" and "PMA approval".
In its raw-material purchases, i-SENS lists carbon paste (a raw material for glucose strips) at KRW 14,942 million in 2025 (15.4% of purchases) and a meter component labeled "IR Sensor" at KRW 27,448 million (28.2%) Sourced. The annual report describes the strip as a disposable item that contains an enzyme reacting with glucose in the blood to produce an electrochemical reaction, and the CGM manual gives a GDH-FAD (FAD-dependent glucose dehydrogenase) electrochemical method with a measuring range of 40-500 mg/dL Sourced. Apart from the enzyme type, the CGM manual does not state the mediator, electrode materials or membrane Not yet confirmed. Chapter 10 goes into more detail.
6. What it has done so far
| When | What happened | Why it matters |
|---|---|---|
| 4 May 2000 | Founded (annual report) | The two current representative directors, Geun-Sik Cha and Hak-Hyun Nam, both previously taught chemistry at Kwangwoon University (officer biographies in the annual report; both have served more than 25 years) |
| 2003 | Launched the CareSens meter with a 0.5-microliter blood sample and a 5-second measurement (the company's description) | The selling point of its strips (the company's claim) |
| January 2013 | Listed on KOSDAQ. Acquired a stake in the U.S. company Nano-Ditech the same year | An entry point into point-of-care testing (POCT) |
| 2016 | Acquired CoaguSense, Inc. (coagulation) and set up local subsidiaries in Germany and Malaysia | Expansion in POCT and overseas bases |
| 2018 | Ranked first in the Korean blood glucose meter market with a 31% share (company history), and had capacity for more than 1.6 billion strips a year | The company's own statement; we did not confirm the source of the market share |
| December 2020 | Designated an "Innovative Medical Device Company" by the Ministry of Health and Welfare | An official designation |
| July 2023 | Acquired AgaMatrix, Inc. (U.S.; KRW 37,437 million; 100%) | A U.S. blood glucose meter business and customer base |
| September 2023 | Launched CareSens Air (CGM), described in the company history as Korea's first domestically developed CGM. The Songdo second plant was completed in October | The entry point for its own CGM |
| 2024 | Launched in Europe and elsewhere (14 countries by the end of 2024). A KRW 50,000 million private convertible bond in April | Overseas expansion and fundraising |
| March 2025 | The upgraded CareSens Air was launched in Korea and Europe. CE approval in Europe on 25 March. Warm-up cut from two hours to 30 minutes, optional calibration, and a smartwatch app | The company's announcement |
| April 2025 | Launched "My Health Phone" with Samsung (company history) | Link to smartphones and watches |
| October-November 2025 | Launched the CareSens Air Receiver (a dedicated display) in Europe. The company said it planned to reach more than 30 countries by the end of 2025 and had secured insurance reimbursement in six countries including Korea | A display device to meet European reimbursement and public-tender requirements |
| February 2026 | Announced a partnership with LifeScan: a OneTouch Vita-branded continuous glucose monitor expected to launch in Germany, Ireland, Portugal and Belgium by early 2027 | Extends supply and manufacture of its CGM to another company's brand |
| March and September 2026 | Introduced the next-generation "CareSens Air 2" at ATTD 2026. For EASD 2026 (28 September to 2 October) it announced an early-2027 launch, a smaller and lighter sensor, a longer wear period, a new app and Samsung Health integration | The company's announcement (as far as could be confirmed) |
7. What comes next
Everything below is a company plan or expectation, not something already achieved Not yet confirmed.
CGM revenue within the annual report's consolidated breakdown; the approval status and wear days of CareSens Air 2; whether a submission has been made to the FDA; the status in Japan; the amounts, term and exclusivity of the LifeScan agreement; the CGM sensor's electrode and membrane materials beyond the enzyme; the strip enzyme and mediator; the CGM's contract manufacturers and component suppliers; and named university collaborations or public research bodies.
8. What the company is aiming for in biosensors
This chapter separates what the company says directly from what we have read into its materials. Inference marks our interpretation of primary sources.
| What can be read | Primary evidence | Status |
|---|---|---|
| It is applying its strip manufacturing strength to making and supplying CGMs for other brands too | LifeScan's release says it combines "i-SENS advanced technology and manufacturing capacities" with the OneTouch brand and distribution network. The IR material also contains wording readable as "CareSens Air or private label supply" | Sourced (content of the partnership) / Inference (link to strip experience) |
| In Europe it is lining up products to meet reimbursement and public-tender requirements | The company explains that it launched the dedicated receiver for reimbursement requirements in Germany and the Netherlands and public-tender requirements in Italy, Finland and Spain | Sourced (the company's explanation) |
| It is extending the CGM to data management and smartphone and watch links | Sens365 (data sharing with clinicians), a smartwatch app, Samsung Health integration and My Health Phone with Samsung | Sourced (products, links) / Inference (aim) |
| It is building large spare CGM capacity ahead of demand | Capacity of 2 million units a year against 2025 production of 563,598 (28.2% utilization); further equipment spending follows | Sourced (figures) / Inference (intent of the advance investment) |
The reading "it is building large spare CGM capacity ahead of demand" rests on the production table in the annual report. CGM capacity in 2025 was 2 million units a year (up from 500,000 the year before, four times as much), production was 563,598 (183,570 the year before), and average utilization was 28.2%. Production in the first half of 2026 was 563,216, matching the whole of the previous year in six months Sourced. The company said in October 2025 that completing the automated line at the Songdo second plant secured a capacity of two million units a year. But whether orders will fill that capacity is not stated, and the volume for LifeScan is not disclosed Not yet confirmed.
9. Map of partnerships in biosensors
The relationships that can be confirmed are LifeScan (the CGM partnership), Samsung (device and app links), Arkray (the largest customer), and AgaMatrix and CoaguSense (subsidiaries) Sourced. The owners of the ODM brands (ReliOn Premier, BGStar, Barozen), the OEM customers, and the suppliers of CGM components are not in the materials we reviewed Not yet confirmed.
10. Technologies, products and services
The performance values below are manufacturer's stated values (the company manual); they must be read with the study conditions (reference method and number of participants), and values from different studies, or from other companies' products, cannot be lined up to rank them.
| Category | What the official materials say | Note |
|---|---|---|
| Glucose meters and strips (CareSens, NoCoding1 and others) | Meters, strips that contain an enzyme, and lancets. 1.67 billion strips were produced in 2025. Own brands plus ODM and OEM. The annual report says the products are managed under a system meeting ISO 15197 | In FDA terms, an OTC blood glucose meter category. See our explainer on electrochemical sensors |
| CGM (CareSens Air) | The sensor is worn on the back of the upper arm for up to 15 days and sends data by Bluetooth every 5 minutes. Dimensions 35.2 x 19.2 x 5.0 mm, weight 4.5 g. Water resistance IP48 (1 m for 24 hours). CR1632 battery. EO sterilization, 18-month shelf life | Wear site and days are as stated in the manual |
| Display, app and data management | The CareSens Air Receiver (a dedicated display), the CareSens Air app, and Sens365 (sharing with healthcare professionals) | The receiver is for cases such as when a smartphone cannot be used |
| POCT (point-of-care testing) | i-Smart 30 and 300 (electrolytes and blood gases), A1Care (HbA1c), Coag-Sense (coagulation) and an immunoassay analyzer. 2025 sales: electrolytes and gases KRW 18,954 million, coagulation KRW 19,055 million | Includes instruments using optical measurement |
| Veterinary diagnostics | A diagnostic system for animal clinics (a product category on the website) | Not covered in detail here |
CareSens Air performance (company manual)
| Item | Value | Conditions and source |
|---|---|---|
| Overall MARD | 9.5% (2022 study) / 8.7% (2024 study) | 2022: 50 participants aged 18 or older with type 1 or type 2 diabetes, venous comparator. 2024: 30 such participants, capillary comparator. The comparisons are not under the same conditions |
| MARD by day worn (2022) | Day 1 11.6%, day 2 10.3%, day 5 9.4%, day 6 9.3%, day 10 9.1%, day 15 7.7% | Same study |
| MARD by wear period (2024) | Days 2-5 9.7%, days 6-10 7.9%, days 11-15 8.5% | Same study |
| Range and method | 40-500 mg/dL, electrochemical, GDH-FAD | Technical data in the manual |
| Operating and storage conditions | Use 10-45 °C / storage 5-30 °C | The outer surface of the sensor can reach 48 °C in use |
MARD (mean absolute relative difference) is the average of the relative gaps between sensor and comparator values; it changes with study conditions. The manual states that interstitial glucose changes 5 to 15 minutes after blood glucose, that readings may be higher than actual with intravenous vitamin C, that the sensor must be removed before X-ray, MRI or CT, and that it has not been evaluated or approved for pregnant or breastfeeding women, dialysis patients or critically ill patients Sourced. This article is not guidance on reading measurements or on using the product.
Strips and the CGM share one idea: an enzyme drives a reaction and an electrode reads it as current (see our explainer on enzyme and electrode interface materials). The materials points that can be read from the annual report and the manual are as follows Sourced.
- Electrode paste: carbon paste is 15.4% of raw-material purchases (2025). The company says the quality of the printed electrodes governs strip stability (stable production processes).
- The CGM enzyme: GDH-FAD. FAD-GDH is generally described as less affected by oxygen concentration (our commentary). Higher readings with intravenous vitamin C reflect a general issue for electrochemical methods, sensitivity to substances that oxidize easily at the electrode (our commentary).
- Sterilization and storage: EO sterilization, an 18-month shelf life and storage at 5-30 °C. Packaging is Tyvek with PET, and PET with an aluminum sheet, with a desiccant.
- Fixing to the skin: the company describes a "safe and durable skin adhesive tape"; holding for 15 days together with IP48 water resistance is a design issue (see our explainer on patch sensors and skin adhesion).
- Meter housing: FDA document K170614 records changes to the meter case materials: PC to PMMA for the screen, POM for the eject button, TPE for the feet and silicone rubber for the buttons.
However, the CGM's electrode materials, mediator and diffusion-limiting membrane, and the strip enzyme type, are not stated in the materials we reviewed. This article does not fill the gap by guessing.
11. The risks this company carries
| Risk | Detail | Status |
|---|---|---|
| Dependence on customers and OEM/ODM business | Arkray, Inc. accounted for about 14.8% of 2025 consolidated revenue (about 17.6% the year before). A large share of revenue comes from ODM and OEM customers. The nature of the business is not described | Sourced / Inference (degree of dependence) |
| Earnings volatility | Consolidated net income was a loss of KRW 1,953 million in 2024 and KRW 6,690 million in 2025, and a profit of KRW 5,571 million in the first half of 2026. Operating profit fell to KRW 2,658 million in 2024. We did not confirm the main causes of the losses | Sourced |
| Currency | About 80% of revenue is exported, exposing the company to U.S. dollar and euro exchange risk. The annual report says part of it is hedged with derivatives | Sourced |
| The CGM ramp-up | Utilization of CGM capacity was 28.2% in 2025. Sales are small (KRW 6.7 billion in the first half of 2025), and they do not appear separately in the annual report's consolidated breakdown. Its status with the FDA could not be confirmed | Sourced / Not yet confirmed |
| Gap with larger competitors | The annual report itself says the company is weaker than the world's four largest players in financial strength and brand recognition | Sourced |
| Subsidiary losses and finances | CoaguSense and the Hong Kong subsidiary, among others, recorded net losses in 2025. The debt ratio was 70.7% (72.3% the year before). KRW 19,242 million of the convertible bond remains outstanding, and commitments for the Magok industrial complex are KRW 12,044 million | Sourced |
| Undisclosed partnership terms | The amount, term and exclusivity of the LifeScan partnership are not public, and launch is expected by early 2027. Approval of CareSens Air 2 could not be confirmed | Not yet confirmed |
| Materials and interference | The manual says readings can be higher than actual with intravenous vitamin C, a general issue for electrochemical methods | Sourced |
12. Glossary
- ODM / OEM
- In ODM, a maker designs and manufactures a product sold under another company's brand; in OEM, it manufactures to the other company's design.
- Strip (test strip)
- A disposable strip with electrodes that a blood sample is applied to. It contains an enzyme and turns the reaction into current.
- CGM (continuous glucose monitoring)
- Measuring glucose in subcutaneous interstitial fluid continuously with a sensor.
- GDH-FAD
- FAD-dependent glucose dehydrogenase: an enzyme that oxidizes glucose and passes electrons to the electrode.
- MARD
- Mean absolute relative difference: the average relative gap between sensor and comparator values. It changes with study conditions.
- POCT
- Point-of-care testing: testing at the patient's location rather than in a central laboratory.
- DART
- Korea's electronic disclosure system, where listed companies' annual and half-year reports are published.
- KOSDAQ
- The Korean stock market for growth companies.
- 510(k) clearance
- An FDA category recognizing substantial equivalence to a device already on the market. Different from De Novo authorization and PMA approval.
- OTC (over the counter)
- Available without a prescription. FDA product code NBW is for over-the-counter blood glucose test systems.
13. References
- DART (Korea's electronic disclosure system) Annual Report for the year ended December 2025 (filed 18 March 2026; 26th fiscal period). Company overview, main products and sales, raw materials and production facilities, sales results, R&D, financials, employees, subsidiaries and investments, MD&A. https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657
- DART (Korea's electronic disclosure system) Half-Year Report for 30 June 2026 (filed 14 August 2026; 27th fiscal period). First-half 2026 revenue and profit, production, R&D, fundraising, contingent liabilities. https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260814001297
- i-SENS Official website, History. https://i-sens.com/history/
- i-SENS Official news, "LifeScan Announces Transformational Partnership with i-SENS to Launch OneTouch Continuous Glucose Monitoring System" (February 2026). https://i-sens.com/lifescan-announces-transformational-partnership-with-i-sens-to-launch-onetouch-continuous-glucose-monitoring-system/
- LifeScan Press release (11 February 2026). Partnership with i-SENS to launch a continuous glucose monitoring system under the OneTouch Vita brand in Europe. https://www.lifescan.com/news-and-updates/2026-press-releases/lifescan-announces-transformational-partnership-with-i-sens-to
- i-SENS Official news, "i-SENS Announces Global Launch of CareSens Air Receiver" (October 2025). https://i-sens.com/i-sens-announces-global-launch-of-caresens-air-receiver/
- i-SENS Official news, "Spotlight on i-SENS at ATTD 2025." CE approval of the upgraded CareSens Air (25 March 2025) and the shorter warm-up. https://i-sens.com/spotlight-on-i-sens-at-attd-2025/
- i-SENS Official news, "i-SENS to Showcase Next-Generation CGM Innovations at EASD 2026." CareSens Air 2, Sens365 and Samsung Health integration. https://i-sens.com/i-sens-to-showcase-next-generation-cgm-innovations-at-easd-2026/
- i-SENS Official news, "i-SENS Unveils the Next Chapter of CGM at ATTD 2026." https://i-sens.com/i-sens-unveils-the-next-chapter-of-cgm-at-attd-2026/
- i-SENS CareSens Air user manual (15-day version, PCGAA-000123 REV6, March 2026). Intended use, contraindications, specifications and accuracy. https://caresensair.com/downloads/3168/
- i-SENS CareSens Air official product page (15 days, every 5 minutes, dimensions, water resistance). https://caresensair.com/en_US/content/product_01/
- i-SENS Company Presentation 4Q 2024 (IR material; only the legible parts could be confirmed because some characters are missing). https://i-sens.com/PDF/i-SENS-Company-Presentation-4Q-2024.pdf
- FDA (openFDA) 510(k) database records for I-Sens, Inc. (27 records, decisions from 2008 to 2023). https://api.fda.gov/device/510k.json?search=applicant:%22I-Sens%22&limit=30
- FDA 510(k) K170614, CareSens N Premier Blood Glucose Monitoring System (19 October 2017). https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170614.pdf
- FDA 510(k) K230625, ReliOn Premier BLU Blood Glucose Monitoring System (10 August 2023). https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230625.pdf
- FDA (openFDA) 510(k) database records for AgaMatrix (K241304 WaveSense Jazz, 6 June 2024, and others). https://api.fda.gov/device/510k.json?search=applicant:AgaMatrix&limit=20
- i-SENS Official website (home page; source of the logo image). https://i-sens.com/
14. Claim-to-source audit
| Claim in the text | Status | Source |
|---|---|---|
| Legal name, founding date (4 May 2000), KOSDAQ listing (30 January 2013), headquarters, mid-sized enterprise | Sourced | Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 |
| Consolidated revenue, operating profit and net income (2023-2025) and first-half 2026 figures | Sourced | Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 Reference 2 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260814001297 |
| 2025 revenue breakdown (meters and strips 81.1%, electrolytes and gases 6.0%, coagulation 6.0%, goods 6.0%, other 0.9%) and the main brands (own, ODM, OEM) | Sourced | Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 |
| Exports of KRW 247,034 million, revenue by customer location, and sales to Arkray, Inc. of KRW 46,671 million | Sourced | Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 |
| 957 employees (end of 2025) and 997 (end of June 2026); the structure of the research institutes (3 institutes, 12 teams) | Sourced | Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 Reference 2 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260814001297 |
| R&D expense, its share of revenue, and government subsidies | Sourced | Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 Reference 2 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260814001297 |
| Production capacity and output (strips, meters, CGM) and utilization | Sourced | Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 Reference 2 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260814001297 |
| Facilities: Songdo second plant investment, CGM equipment plan (KRW 33,910 million in total, by year), Magok commitments | Sourced | Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 Reference 2 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260814001297 |
| AgaMatrix (10 July 2023; 100%; KRW 37,437 million), CoaguSense (75.3%), number of investments, KRW 50,000 million convertible bond | Sourced | Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 Reference 2 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260814001297 |
| History: CareSens (2003), CareSens Air launch (September 2023), AgaMatrix acquisition, Songdo second plant, My Health Phone with Samsung, Innovative Medical Device Company designation | Sourced | Reference 3 https://i-sens.com/history/ |
| CE approval of the upgraded CareSens Air (25 March 2025), shorter warm-up, launch in 14 countries | Sourced | Reference 7 https://i-sens.com/spotlight-on-i-sens-at-attd-2025/ |
| CareSens Air Receiver, the plan for more than 30 countries, reimbursement in six countries, CGM sales (KRW 6.0 billion in 2024; KRW 6.7 billion in the first half of 2025), capacity of 2 million units a year | Sourced | Reference 6 https://i-sens.com/i-sens-announces-global-launch-of-caresens-air-receiver/ |
| Partnership with LifeScan (OneTouch Vita; launch expected by early 2027 in Germany, Ireland, Portugal and Belgium) | Not yet confirmed | Reference 4 https://i-sens.com/lifescan-announces-transformational-partnership-with-i-sens-to-launch-onetouch-continuous-glucose-monitoring-system/ Reference 5 https://www.lifescan.com/news-and-updates/2026-press-releases/lifescan-announces-transformational-partnership-with-i-sens-to |
| CareSens Air 2 (planned for early 2027), Sens365 and Samsung Health integration | Not yet confirmed | Reference 8 https://i-sens.com/i-sens-to-showcase-next-generation-cgm-innovations-at-easd-2026/ Reference 9 https://i-sens.com/i-sens-unveils-the-next-chapter-of-cgm-at-attd-2026/ |
| CareSens Air intended use, contraindications, specifications (GDH-FAD, 40-500 mg/dL, 15 days, dimensions, IP48, EO sterilization, 18 months), MARD, vitamin C, storage and operating conditions | Sourced | Reference 10 https://caresensair.com/downloads/3168/ Reference 11 https://caresensair.com/en_US/content/product_01/ |
| FDA 510(k): 27 records for I-Sens, Inc., K170614 (CareSens N Premier) and K230625 (ReliOn Premier BLU) | Sourced | Reference 13 https://api.fda.gov/device/510k.json?search=applicant:%22I-Sens%22&limit=30 Reference 14 https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170614.pdf Reference 15 https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230625.pdf |
| AgaMatrix FDA 510(k) records (K241304, 6 June 2024, and others) | Sourced | Reference 16 https://api.fda.gov/device/510k.json?search=applicant:AgaMatrix&limit=20 |
| Changes to meter case materials (PC to PMMA, POM, TPE, silicone rubber) | Sourced | Reference 14 https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170614.pdf |
| CGM supply approach in the IR material (CareSens Air or private-label supply; localized automated production) and the Songdo strip capacity expansion | Sourced | Reference 12 https://i-sens.com/PDF/i-SENS-Company-Presentation-4Q-2024.pdf |
| That no i-SENS CGM was found in the FDA database; status with the PMDA; CGM materials beyond the enzyme; the LifeScan terms; owners of the ODM brands | Not yet confirmed | Not stated in the materials we reviewed. Not confirmed; we do not claim they do not exist. Reference 1 https://dart.fss.or.kr/dsaf001/main.do?rcpNo=20260318001657 Reference 13 https://api.fda.gov/device/510k.json?search=applicant:%22I-Sens%22&limit=30 Reference 10 https://caresensair.com/downloads/3168/ |
| Export share of about 78.3%, Arkray share of about 14.8%, remaining equipment spending of KRW 22,400 million | Our calculation | Our own division and sum using figures from Reference 1 |
| The four-type classification and the example company names | Our calculation | Our own grouping; company names are examples from the companies covered in this series |
| The reading that it applies its strip manufacturing strength to making and supplying CGMs for other brands | Inference | Our interpretation of References 4, 5 and 12 - this article's own reading |
| The reading that it is building spare CGM capacity ahead of demand | Inference | Our interpretation of the capacity and output figures in References 1, 2 and 6 - this article's own reading |
| The aim of extending to data management and smartphone links | Inference | Our interpretation of the products and links in References 8 and 10 - this article's own reading |
| FAD-GDH being generally described as less affected by oxygen concentration; interference from substances easily oxidized at the electrode | Commentary | Commentary in this article (A materials engineer's view), organizing the facts in Reference 10 from a materials viewpoint |
Last updated: 3 October 2026 / Troy Technical
The figures in this article come from i-SENS's DART annual and half-year reports, the company's website and manual, LifeScan's release and FDA public documents. Market-research estimates and press-report figures are not used (the market share in the company history is quoted as the company's own statement). Passages marked "Inference" are our own readings of primary sources and are not statements by the company. This article does not recommend any product, and it is not guidance on treatment or on reading measurements.