CAScination AG

CAScination AG specializes in two primary categories of medical devices: radiology picture archiving and communication system (PACS) workstations and multi-purpose stereotactic surgery systems. Their stereotactic systems, such as the CAS-One platform, feature infrared tracking and modular accessories like guide arms, platforms, and marker templates to enable precision-guided surgical interventions. Additionally, they offer software tools like OTODRIVE and OTOPLAN for surgical planning and imaging navigation.

CAScination AG is headquartered in Switzerland, which means its devices must comply with EU Medical Device Regulations (MDR). Due to this location, the company’s products are listed in EUDAMED, the European database for medical devices. However, since some of their devices are also marketed globally, they are also registered in the FDA’s 510(k) premarket notification system and the FDA’s Unique Device Identifier (UDI) database to meet U.S. regulatory requirements.

CAScination AG’s devices appear in EUDAMED (for EU compliance), the FDA’s 510(k) system (for U.S. premarket clearance), and the FDA’s UDI database (for device identification and traceability). These listings reflect the company’s global market presence, where its Class I, Class II, Class IIa, and Class IIb devices must meet both European and U.S. regulatory standards to ensure safety, performance, and traceability in different jurisdictions.

Under the EU Medical Device Regulations, CAScination AG’s devices fall into Class I, Class II, Class IIa, and Class IIb classifications, depending on their risk level and intended use. For example, stereotactic surgery systems (like CAS-One) are typically higher-risk devices, often classified as Class IIb, requiring stricter pre-market evaluation. In the U.S., these devices are submitted via 510(k) premarket notifications to demonstrate substantial equivalence to existing cleared products, ensuring compliance with FDA requirements.