# fda_de_novo (us_fda)

Galen Robotics receives FDA De Novo Grant for Galen Surgical Robot after five years of development.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_de_novo
- Status: cleared
- Decision date: 2026-01-01

## Covered models (1)

- [Galen Surgical Robot](/models/galen-surgical-robot.md)

## Sources (1)

- [https://i95business.com/articles/content/galen-robotics-celebrates-fda-de-novo-clearance-reflects-on-the-journey-2140](https://i95business.com/articles/content/galen-robotics-celebrates-fda-de-novo-clearance-reflects-on-the-journey-2140)

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