First Deep Learning FDA Clearance
in Asia-Pacific


Deep01 is a Taiwan-based AI software company that located in Taipei. Our focus is developing advanced AI-based SaMD (Software as a Medical Device) for decision support that aims to assist physicians to expedite patient treatment. Deep01 is the first AI company in the world to obtain both U.S. and Taiwan FDA clearances.

Our technology analyzes brain CT imaging to provide smart solutions for notifying and helping ER physicians, radiologists to prioritize the time-sensitive and life-threatening cases and better manage patients in the golden hour.

Deep01 is empowering physicians with our innovative AI solutions.


The team members of Deep01 are from Harvard University, Cambridge University, Carnegie Mellon University, National Taiwan University, National Tsing Hua University, and National Chiao Tung University with profound international work experience and from senior physicians in the US and Taiwan.

David Chou, the founder and CEO of Deep01, graduated from Carnegie Mellon University Computer Science and National Taiwan University Electrical Engineering, and was a research fellow at Harvard University. David was also awarded as 2020 Ten Outstanding Young Persons (十大傑出青年) by President.



2019 Awarded 1st place in AWS Cloud Challenge by Amazon
2020 Awarded 1st place in Top 10 Tech Startups by Government
2021 Awarded 1st place in Taipei Biotech Awards by Government


2019 1st US FDA cleared deep-learning product in Asia-Pacific
2020 1st Taiwan FDA cleared deep-learning product in the world
2021 1st Japan PMDA cleared deep-learning product in Taiwan
2021 CE / ISO13485 / Thailand FDA / Hong Kong FDA / Malaysia FDA cleared


2020 Asus, ITRI invested for the Pre-A round (Angel Investor: US Plug and Play)
2020 Deep01 CEO was awarded as 10 Outstanding Young Persons (十大傑出青年) by President