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Medical AIKOSDAQ 380550Innovative Medical Device20 approvals

NEUROPHET Inc.

Official website

Founded in 2016 and listed on KOSDAQ in 2025, Neurophet develops AI brain-imaging solutions AQUA, SCALE PET, and AQUA AD.

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Products & technology

  • Neurophet AQUAMRI-based brain neurodegeneration/damage analysis for early dementia diagnosis
  • Neurophet SCALE PETAutomated quantitative analysis of PET imaging tracers
  • Neurophet AQUA ADAlzheimer treatment eligibility, efficacy, and ARIA severity assessment
  • Imaging CRO serviceClinical trial patient selection and quantitative efficacy analysis

Regulatory approvals

data.go.kr · openFDA

2 Innovative Medical Device designations · 2024–2025 / 12 Korean MFDS device approvals · 2019–2025 / 6 US FDA 510(k) · 2022–2026

  • InnovativeNeurophet AQUA AD Plus2025-08-20
    Innovative Medical Device designation
  • Innovativeinnk-P012024-09-23
    Innovative Medical Device designation
  • FDANeurophet SCALE PET2026-05-15
    510(k) · TraditionalRadiologyK252563
  • FDANeurophet AQUA2026-05-15
    510(k) · SpecialRadiologyK261273
  • FDANeurophet AQUA AD Plus2026-01-29
    510(k) · TraditionalRadiologyK252496
  • MFDSProduct name not recorded2025-08-25
    Product approval · Class 2인 25-4037 호
  • MFDSBrain electrical stimulation system, psychiatric therapy2025-07-22
    Product approval · Class 3제허 25-495 호
  • MFDSNeural image, computer aided detection/diagnosis software2025-05-13
    Product approval · Class 3제허 25-313 호
  • MFDSNeural image, computer aided detection/diagnosis software2025-04-02
    Product approval · Class 3제허 25-224 호
  • MFDSNeural image, analysis software2024-12-30
    Product approval · Class 2제인 24-1194 호
  • FDANeurophet AQUA (V3.1)2024-10-25
    510(k) · TraditionalRadiologyK242215
  • FDANeurophet AQUA2023-05-10
    510(k) · TraditionalRadiologyK220437
Show 8 more
  • MFDSGuide for medical use2022-08-11
    Product approval · Class 1제신 22-1117 호
  • FDANeurophet SCALE PET2022-08-05
    510(k) · TraditionalRadiologyK221405
  • MFDSNeural image, analysis software2022-02-24
    Product approval · Class 2제인 22-4149 호
  • MFDSBrain electrical stimulation system, psychiatric therapy2021-07-21
    Product approval · Class 3제허 21-621 호
  • MFDSNeural image, treatment planning software2021-06-15
    Product approval · Class 2제인 21-4522 호
  • MFDSNeural image, analysis software2020-08-20
    Product approval · Class 2제인 20-4771 호
  • MFDSElectrode, external2020-06-16
    Product approval · Class 1제신 20-877 호
  • MFDSNeural image, treatment planning software2019-02-18
    Product approval · Class 2제인 19-4106 호
Not yet compiled: business overview · R&D. Send us materials and we will add them

Companies approved for the same productsMedical AI

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

JLK, Inc.3 shared

JLK offers the stroke AI solution MEDIHUB STROKE and holds 78 global regulatory approvals, including US FDA and Japan PMDA clearances.

CELLUMED CO., LTD.2 shared

KOSDAQ-listed holding company making medical devices and biologics including bone graft rhBMP2 and knee implant TKR.

Coreline Soft Co., Ltd2 shared

Founded in 2012, Coreline Soft provides the AI-based chest CT diagnostic aid suite AVIEW for lung nodules, COPD, and coronary calcification.

SHINHUNG CO.,LTD2 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

Bistos Co., Ltd.1 shared

Founded in 2001 and KOSDAQ-listed in 2022, Bistos manufactures fetal, neonatal, and patient monitoring medical devices.

HANDOK Inc.1 shared

KOSPI-listed comprehensive pharma company behind Amaryl diabetes drug and the USD 86.25M HL5101 anticancer out-license deal.

L&K BIOMED CO., LTD.1 shared

Spinal implant device maker founded 2008, listed on KOSDAQ 2016; produces Cervical and Thoraco Lumbar Cage, Screw, and Plate products.

MEDIANA Co.,LTD1 shared

Founded in 1995 and listed on KOSDAQ in 2014, Mediana is a hospital medical device maker developing and manufacturing patient monitors and automated external defibrillators under its own brand and via ODM.

Organ Eco Tech Co.,Ltd.1 shared

Organ Eco Tech, founded in 2006 and KONEX-listed in 2016, manufactures spinal implants.

Ray Co., Ltd.1 shared

KOSDAQ-listed dental medical device company offering the RAYSCAN digital diagnostic system and RAYDENT digital treatment solutions.

SEWOONMEDICAL CO,. LTD.1 shared

Founded in 1982 and KOSDAQ-listed in 2008, Sewoon Medical manufactures medical aspirators and catheters/tubes.

VUNO, Inc.1 shared

Founded in 2014, VUNO provides AI-based vital-sign and medical imaging diagnostic solutions, including VUNO Med-DeepCARS and VUNO Med-Fundus AI.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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