Deep01 Received CE Mark –
Accumulating 4 Validations Globally
Mar. 4th, 2021

Deep01, a Taiwan-based software startup that develops AI-based solutions for intracranial hemorrhage detection which can be applied in hospitals to improving workflow, has received several validations in the world.

In July of 2019, Deep01 obtained its first FDA, which is the first deep learning US FDA in Asia Pacific. The good start is continued by the approval of FDA of Taiwan and Thailand which was obtained in the February and September of 2020.

The approval of Deep01 in its home country is also significant since it is the first Taiwan FDA using deep learning technology. The latest validation is CE mark which was received in Feb. 2021, accumulating a total of 4 validation in the world. With its achievement of regulatory clearance within one and a half year, Deep01 is optimistic of the development of global market.