
Products
About
HippoScreen Neurotech Corp. (HNC) was established in March 2019 by Compal Computer's direct investment in the research team of Professor Liu, Yi-Hung. The company takes EEG signal processing and artificial intelligence technology as the core, aiming to develop EEG-assisted diagnosis and medical services. Its self-developed EEG amplifier cleared FDA 510(k) at the end of 2020, completed the TFDA review, and received approval for the medical device in March 2021, becoming the first medical-grade EEG amplifier manufacturer in Taiwan.
In addition, HippoScreen also passed ISO 13485 medical device quality management system certification, received a certificate from BSI in August 2022, and registered to the BSI certification website. Through this professional international standard certification, it is expected that HippoScreen will be able to enter the worldwide market as soon as possible.
Milestone
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Jul. 2024
SEA receives Taiwan BIO Awards
SEA Received “Annual Industry Innovation Award” of 2024 Taiwan BIO Awards.
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Oct. 2023
SEA Obtains Taiwan FDA clearance for Software as a Medical Device (SaMD)
First regulatory body approved AI-assisted diagnostic aid for Depression.
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Dec. 2022
Official launch of "Brain Degeneration Risk (BDR) Assessment System"
Development of the system completed using MCI EEG data collected through collaboration with four major medical centers in Taiwan, and product promotion begins.
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Dec. 2022
HippoScreen has won the 19th National Innovation Award
The "Stress EEG Assessment (SEA) System" is recognized and awarded the "Enterprise New Creation Award - Smart Medical and Health Technology Category".
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Aug. 2022
HippoScreen obtained the ISO 13485:2016 certificate
The design, development, and manufacturing of HippoScreen's EEG recorder and Stress EEG Assessment (SEA) System passed the BSI audit, and in August 2022, it officially obtained the ISO 13485:2016 certificate (MD 770476) and was registered on the BSI certification website.
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Jun. 2022
Stress EEG Assessment System passed the TFDA QMS audit and received a manufacturing license
The Stress EEG Assessment (SEA) System passed the TFDA QMS audit in June 2022, becoming one of the first domestically produced software asmedical devices (SaMD) to obtain a QMS manufacturing license, and was registered in the domestic QMS/GMP manufacturing license dataset (number QMS2055).
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Dec. 2021
Paper published: Resting-State EEG Signal for Major Depressive Disorder Detection
Research collaboration with three major medical centers in Taiwan, published in SCI journal biosensors (impact factor 5.743)
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Nov. 2021
Approved by the Ministry of Economic Affairs as a "Biotech New Drug Company"
Applies for and obtains approval as a "Biotech New Drug Company" according to the "Biotech New Drug Industry Development Act" in November 2021.
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Apr. 2021
Official launch of "Stress EEG Assessment (SEA) System"
Development of the system completed using depression EEG data collected through collaboration with three major medical centers in Taiwan, and product promotion begins.
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Mar. 2021
Initiated IRB research to collect MCI & Dementia EEG data
Collaborated with 4 medical centers in Taiwan to collect MCI & Dementia EEG data.
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Mar. 2021
Received TFDA approval and EEG Amplifier is registered
HippoScreen is the first Taiwan manufacturer to complete TFDA review and receive approval for the medical brainwave device.
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Jan. 2021
Raised USD 2.5M
Raised USD 2.5M and the total capital was increased to USD 3.6M
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Dec. 2020
EEG Amplifier is FDA 510(k) cleared
EEG Amplifier is FDA 510(k) cleared and HippoScreen becomes the first medical brainwave device manufacturer in Taiwan.
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Jan. 2020
Initiated IRB research to collect depression EEG data
Collaborated with 3 medical centers in Taiwan to collect depression EEG data.
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Dec. 2019
EEG Amplifier was certified as medical device by SGS
EEG Amplifier passed a series of tests, including safety, EMC, performance, software validation and usability test, and was certified to comply with IEC 60601-1 and IEC 60601-2-26.
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Mar. 2019
Company establishment
Obtained investment from Compal Electronics and officially established HippoScreen Neurotech Corp. (HNC).