BIOSENSE WEBSTER (ISRAEL) LTD.

Biosense Webster (Israel) Ltd. specializes in electromagnetic and optical surgical navigation device tracking systems. These systems are designed to assist in precise surgical procedures by providing real-time tracking and mapping, ensuring enhanced accuracy and safety during interventions. Their portfolio includes products like the Carto ENT, TruDi Navigation System, CARTO 3 SYSTEM, and nGEN, all focused on improving navigation in medical procedures.

Biosense Webster (Israel) Ltd. is headquartered in Israel. While the country of origin does not directly determine regulatory classification, it influences the regulatory pathways devices must follow. For example, their devices are classified under EU regulations as Class II, Class IIa, or Class IIb, which dictates the level of scrutiny and authorization required before they can be placed on the market in the EU or the US. This classification ensures that devices undergo rigorous evaluation to meet safety and performance standards.

Devices from Biosense Webster (Israel) Ltd. are listed in the EUDAMED database and the FDA UDI (Unique Device Identifier) system. Listing in these databases is critical because it provides transparency and traceability for regulators, healthcare providers, and patients. EUDAMED ensures compliance with EU medical device regulations, while the FDA UDI system helps track devices in the US market, supporting post-market surveillance and recall management.

Devices manufactured by Biosense Webster (Israel) Ltd. are classified as Class II, Class IIa, or Class IIb under regulatory frameworks like those in the EU and US. This classification is determined by factors such as the device’s intended use, potential risks, and the level of intervention it involves. Class II devices, for example, are considered to pose moderate risks and require additional controls beyond general good manufacturing practices, such as design validation and post-market surveillance, to ensure their safety and effectiveness.