Company profile

Biosense Webster, Inc.

Biosense Webster, Inc. has 2 AI-enabled medical devices on the FDA list. The first decision was on September 7, 2023 and the most recent on February 20, 2026 (CARTO™ 3 EP Navigation System V8.4). Its most common review panel is Cardiovascular (2 devices).

2AI devices
2023First decision
2026Latest decision
1Specialties

Timeline

  1. CARTO™ 3 EP Navigation System V8.4 · Cardiovascular · DQK
  2. CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) · Cardiovascular · DQK