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Our Story

Certificates / Awards

Our commitment to quality, innovation, and regulatory excellence is reflected
in the certifications, designations, and awards we have earned.
These milestones demonstrate our dedication to developing safe, clinically validated
focused ultrasound technologies that advance the treatment of brain diseases.

Certificate of GMP

Certificate

Certificate of GMP

Medical Device Manufacturing License

Certificate

Medical Device Manufacturing License

ISO13485 Certificate

Certificate

ISO13485 Certificate

FDA Orphan Drug Designation

Designation

FDA Orphan Drug Designation

Innovative Medical Device Designation MFDS - The Advanced Technology Group (No. 80)

Designation

Innovative Medical Device Designation MFDS - The Advanced Technology Group (No. 80)

Challenge! K-Startup 2024, Grand Prize
 (Minister of SMEs and Startups Award)

Award

Challenge! K-Startup 2024, Grand Prize
 (Minister of SMEs and Startups Award)

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