Zydus Amplitude Clinches CE Mark for Andy, Its Advanced Robotic Surgical System

Zydus Amplitude Advances Medical Technology with CE Mark for Andy Robot

Zydus Lifesciences announced that its medtech subsidiary, Zydus Amplitude, has received the CE Mark approval for Andy, its flagship robotic surgical system. Andy is designed to enhance surgical precision, reduce invasiveness, and improve patient outcomes, aligning with global trends toward automation and digitization in healthcare.

This regulatory milestone allows Zydus Amplitude to market and sell Andy across European Economic Area countries, tapping into the growing demand for high-tech surgical solutions. The CE Mark certification follows rigorous testing and compliance with stringent EU medical device regulations.

The launch strengthens Zydus’s portfolio beyond pharmaceuticals into medical devices and surgical robotics, propelled by its strategic acquisition of Amplitude Surgical, a European leader in orthopedic technologies. Andy’s modular design and AI-driven features position it as a competitive offering in robotic-assisted surgeries.

Zydus Leadership emphasizes that the CE Mark is a testament to their innovation-driven culture and commitment to advancing patient-centric healthcare solutions globally.

Key Highlights:

Zydus Amplitude obtains CE Mark for Andy, its robotic surgical system.

Approval enables sales across the European Union market.

Andy enhances surgical precision with AI-driven robotic assistance.

Certification under strict EU medical device regulations.

Expansion builds on acquisition of Amplitude Surgical in orthopedics.

Positions Zydus as a growing player in global medical technology.

Source: Zydus Lifesciences official statement, Business Standard, ScanX Trade (2025)