Medical AI Alliance
← Company Index
Medical DevicesKOSDAQ 099190378 approvals

i-SENS, Inc.

Official website

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

As of 2026-10-09, i-SENS, Inc. has 352 Korean MFDS device approvals, 26 US FDA clearances/approvals, 4 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

Price

Change

Market cap

Business overview

Source: DART corporate disclosure

Founded in 2000 and listed on KOSDAQ in 2013, i-SENS is a blood glucose monitor and point-of-care testing (POCT) company. It offers the CareSens self-monitoring blood glucose meter launched in 2003, the CareSens Air continuous glucose monitor launched in September 2023, and electrolyte/blood gas analyzers and cartridges and HbA1c analyzers and cartridges. CareSens features a 0.5 μL sample size and 5-second measurement time, CareSens Air recorded a MARD of 9%, and the company plans to launch a second-generation product, tentatively named CareSens Air2, with improved price competitiveness.

Products & technology

  • CareSensBlood glucose measurement
  • CareSens AirContinuous glucose monitoring
  • CareSens Air2 (tentative)Second-generation continuous glucose monitor
  • Electrolyte/blood gas analyzers and cartridgesPOCT electrolyte and blood gas analysis
  • HbA1c analyzers and cartridgesHbA1c measurement
  • Immunosensors (cardiovascular disease, COVID-19 antibodies, etc.)Immunodiagnostics

Regulatory approvals

data.go.kr · openFDA

352 Korean MFDS device approvals · 2002–2026 / 26 US FDA 510(k) · 2008–2023

  • MFDSBlood glucose meter for self test2026-09-17
    Product approval · Class 3체외 제허 26-708 호
  • MFDSBlood glucose meter for self test2026-07-27
    Product approval · Class 3체외 제허 26-577 호
  • MFDSIVD strip for glucose self test2026-07-27
    Product approval · Class 3체외 제허 26-576 호
  • MFDSContinuous glucose monitoring systems, self-testing, in vivo2026-07-13
    Product approval · Class 3제허 26-540 호
  • MFDSIVD reagents for electrolyte tests2026-07-08
    Product approval · Class 2체외 제인 26-4625 호
  • MFDSIVD reagents for electrolyte tests2026-07-08
    Product approval · Class 2체외 제인 26-4624 호
  • MFDSBlood glucose meter for self test2026-06-22
    Product approval · Class 3체외 제허 26-471 호
  • MFDSIVD strip for glucose self test2026-06-04
    Product approval · Class 3체외 제허 26-407 호
  • MFDSBlood glucose meter for self test2026-05-27
    Product approval · Class 3체외 제허 26-397 호
  • MFDSBlood glucose meter for self test2026-02-04
    Product approval · Class 3체외 제허 26-105 호
  • MFDSBlood glucose meter for self test2026-01-08
    Product approval · Class 3체외 제허 26-23 호
  • MFDSBlood glucose meter for self test2025-12-26
    Product approval · Class 3체외 제허 25-865 호
Show 68 more
  • MFDSGlucose analyzer for clinical use2025-12-05
    Product approval · Class 1체외 제신 25-1609 호
  • MFDSBlood glucose meter for self test2025-12-04
    Product approval · Class 3체외 제허 25-818 호
  • MFDSBlood glucose meter for self test2025-12-04
    Product approval · Class 3체외 제허 25-817 호
  • MFDSBlood glucose meter for self test2025-12-04
    Product approval · Class 3체외 제허 25-816 호
  • MFDSGlucose analyzer for clinical use2025-12-04
    Product approval · Class 1체외 제신 25-1606 호
  • MFDSClinical IVD strip for glucose strip2025-12-02
    Product approval · Class 2체외 제인 25-5118 호
  • MFDSProduct name not recorded2025-11-14
    Product approval · Class 1신 25-49 호
  • MFDSGlucose analyzer for clinical use2025-10-27
    Product approval · Class 1체외 제신 25-1420 호
  • MFDSClinical IVD strip for glucose strip2025-10-21
    Product approval · Class 2체외 제인 25-4973 호
  • MFDSIVD reagents for electrolyte tests2025-09-26
    Product approval · Class 2체외 제인 25-4908 호
  • MFDSBlood glucose meter for self test2025-08-22
    Product approval · Class 3체외 제허 25-577 호
  • MFDSBlood glucose meter for self test2025-08-22
    Product approval · Class 3체외 제허 25-576 호
  • MFDSContinuous glucose monitoring systems, self-testing, in vivo2025-08-22
    Product approval · Class 3제허 25-575 호
  • MFDSClinical IVD strip for glucose strip2025-07-30
    Product approval · Class 2체외 제인 25-4678 호
  • MFDSClinical IVD strip for glucose strip2025-07-30
    Product approval · Class 2체외 제인 25-4677 호
  • MFDSIVD strip for glucose self test2025-07-29
    Product approval · Class 3체외 제허 25-528 호
  • MFDSIVD strip for glucose self test2025-07-29
    Product approval · Class 3체외 제허 25-527 호
  • MFDSIVD strip for glucose self test2025-07-29
    Product approval · Class 3체외 제허 25-526 호
  • MFDSIVD strip for glucose self test2025-07-29
    Product approval · Class 3체외 제허 25-525 호
  • MFDSIVD strip for glucose self test2025-07-29
    Product approval · Class 3체외 제허 25-521 호
  • MFDSBlood collection unit, non-needle2025-07-25
    Product approval · Class 1제신 25-961 호
  • MFDSBlood glucose meter for self test2025-05-19
    Product approval · Class 3체외 제허 25-326 호
  • MFDSIVD strip for glucose self test2025-03-26
    Product approval · Class 3체외 제허 25-186 호
  • MFDSSpectrophotometer for clinical use2025-02-18
    Product approval · Class 1체외 제신 25-174 호
  • MFDSCuff, blood pressure2024-12-26
    Product approval · Class 1수신 24-2499 호
  • MFDSBlood coagulation analyzer for self test2024-12-19
    Product approval · Class 3체외 제허 24-888 호
  • MFDSIVD reagents for diabetes mellitus2024-11-22
    Product approval · Class 2체외 제인 24-1057 호
  • MFDSIVD strip for glucose self test2024-11-05
    Product approval · Class 3체외 제허 24-768 호
  • MFDSBlood glucose meter for self test2024-09-30
    Product approval · Class 3체외 제허 24-658 호
  • MFDSSphygmomanometer, electronic, automatic-inflation, non-portable2024-07-11
    Product approval · Class 2수인 24-345 호
  • MFDSBlood coagulation analyzer for self test2024-07-02
    Product approval · Class 3체외 제허 24-443 호
  • MFDSIVD reagents for cardiac marker2024-01-17
    Product approval · Class 3체외 제허 24-48 호
  • MFDSBlood glucose meter for self test2024-01-02
    Product approval · Class 3체외 제허 24-4 호
  • MFDSIVD strip for glucose self test2024-01-02
    Product approval · Class 3체외 제허 24-3 호
  • MFDSIVD strip for glucose self test2023-12-21
    Product approval · Class 3체외 제허 23-1170 호
  • MFDSBlood glucose meter for self test2023-12-21
    Product approval · Class 3체외 제허 23-1169 호
  • MFDSIVD reagents for cardiac marker2023-11-28
    Product approval · Class 3체외 제허 23-1092 호
  • MFDSBlood collection unit, non-needle2023-11-24
    Product approval · Class 1제신 23-1685 호
  • MFDSBlood glucose meter for self test2023-09-13
    Product approval · Class 3체외 제허 23-920 호
  • MFDSU-healthcare gateway software, class 1Revoked2023-09-06
    Product approval · Class 1제신 23-1346 호
  • MFDSIVD strip for glucose self test2023-08-22
    Product approval · Class 3체외 제허 23-851 호
  • FDAReliOn Premier BLU Blood Glucose Monitoring System2023-08-10
    510(k) · SpecialClinical ChemistryK230625
  • MFDSContinuous glucose monitoring systems, self-testing, in vivo2023-06-20
    Product approval · Class 3제허 23-690 호
  • MFDSBlood glucose meter for self test2023-02-03
    Product approval · Class 3체외 제허 23-76 호
  • FDALDE4 Lancing Device2022-11-23
    510(k) · TraditionalGeneral, Plastic SurgeryK222656
  • MFDSBlood glucose meter for self test2022-06-10
    Product approval · Class 3체외 제허 22-378 호
  • MFDSIVD strip for glucose self test2022-05-31
    Product approval · Class 3체외 제허 22-360 호
  • MFDSIVD reagents for inflammatory tests2022-04-22
    Product approval · Class 2체외 제인 22-4320 호
  • MFDSClinical IVD strip for glucose strip2022-04-20
    Product approval · Class 2체외 제인 22-4310 호
  • MFDSGlucose analyzer for clinical use2022-04-05
    Product approval · Class 1체외 제신 22-437 호
  • MFDSGlucose analyzer for clinical useRevoked2022-02-23
    Product approval · Class 1체외 제신 22-254 호
  • MFDSBlood glucose meter for self test2022-01-06
    Product approval · Class 3체외 제허 22-7 호
  • MFDSIVD reagents for cardiac marker2021-12-02
    Product approval · Class 3체외 제허 21-975 호
  • MFDSBlood glucose meter for self test2021-11-22
    Product approval · Class 3체외 제허 21-938 호
  • MFDSIVD strip for glucose self test2021-11-02
    Product approval · Class 3체외 제허 21-875 호
  • MFDSBlood glucose meter for self test2021-10-28
    Product approval · Class 3체외 제허 21-865 호
  • MFDSClinical IVD strip for glucose strip2021-10-08
    Product approval · Class 2체외 제인 21-4853 호
  • FDACareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System2021-10-05
    510(k) · SpecialClinical ChemistryK201394
  • MFDSBlood glucose meter for self test2021-08-18
    Product approval · Class 3체외 제허 21-699 호
  • MFDSIVD reagents for diabetes mellitus2021-07-28
    Product approval · Class 2체외 제인 21-4641 호
  • MFDSSpectrophotometer for clinical use2021-07-26
    Product approval · Class 1체외 제신 21-1020 호
  • MFDSIVD reagents for cardiac marker2021-07-12
    Product approval · Class 3체외 제허 21-588 호
  • MFDSIVD reagents for electrolyte tests2021-04-08
    Product approval · Class 2체외 제인 21-4282 호
  • MFDSIVD reagents for electrolyte tests2021-04-08
    Product approval · Class 2체외 제인 21-4281 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2021-03-17
    Product approval · Class 3체외 제허 21-198 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2021-02-23
    Product approval · Class 3체외 제허 21-140 호
  • MFDSHematology analyzer, glycohemoglobinRevoked2021-01-05
    Product approval · Class 1체외 제신 21-4 호
  • MFDSGlucose analyzer for clinical use2020-12-29
    Product approval · Class 1체외 제인 20-5161 호

Showing the 80 most recent of 378 records.

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

면역센서 진단시약키트 · 심혈관질환, 코로나19 항체 등 · 연구개발 · Sensor R&D center developing immunosensor reagents and optical measurement systems

CGMS(연속혈당측정기) 개발 · 당뇨병 관리 · 양산 · CGMS R&D center developed the continuous glucose monitoring sensor and data management system, commercialized as CareSens Air

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 458 more patents

AI reads

MAA server logs · IP-verified
151
Times AI engines pulled i-SENS, Inc.'s records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

1
Fetched fresh mid-answer

Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

150
Index crawls

Collected as raw material for future answers.

0
Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

14
live 0
Last 7 days
121
live 1
Last 30 days
151
live 1
All time
  • OpenAIChatGPT-Userlive1
  • OpenAIOAI-SearchBot120
  • GoogleGoogleOther22
  • PerplexityPerplexityBot6
  • AnthropicClaudeBot2

Measured since Aug 27, 2026 · 4 AI engines · last read Oct 9, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

Connect this index to your AI tool →

Connect this company index directly to your AI

Connect it to ChatGPT or Claude, and your AI queries the full record — profiles, financials, stock data, regulatory approvals, clinical trials, publications and patents — for i-SENS, Inc. and every listed Korean medical, bio and AI company.

How to connect (MCP)
Not yet compiled: business overview. Send us materials and we will add them

Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

SD BIOSENSOR INC.22 shared

KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.

OSANG HEALTHCARE CO.,LTD.18 shared

Founded 1996, listed on KOSDAQ in 2024, OSANG HEALTHCARE develops and sells biochemistry, immunodiagnostic, and molecular IVD products.

GC Medical Science Corporation17 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

Boditech Med Inc.12 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

Access Bio, Inc.9 shared

Founded in 2002 and KOSDAQ-listed in 2013, Access Bio develops rapid diagnostic tests for malaria, COVID-19, and other infectious diseases.

Precision Biosensor Inc.8 shared

KOSDAQ-listed IVD company producing time-resolved fluorescence immunodiagnostic products under the Exdia TRF brand.

RollingStone Co., Ltd.8 shared

KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.

Sugentech, Inc.8 shared

Founded in 2011 and KOSDAQ-listed in 2019, Sugentech develops multiplex immunoblot, point-of-care, and digital healthcare diagnostics.

DONG-A ST CO.,LTD8 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

GENEMATRIX INC.7 shared

KOSDAQ-listed biotech company developing molecular diagnostics with proprietary C-Tag technology and the NeoPlex product line.

HUMASIS CO., LTD.6 shared

KOSDAQ-listed IVD company producing COVID-19 and HIV point-of-care diagnostic reagents alongside rubber products and entertainment businesses.

PCL. Inc5 shared

KOSDAQ-listed IVD company using SG Cap™ multiplex diagnostic technology for infectious disease, cancer, and companion animal testing.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

Request a correction or addition