AngioDynamics Inc. announced that it received FDA approval in November 2025 for its Investigational Device Exemption $(IDE)$ application for the APEX-Return pivotal study. This study will evaluate the safety and effectiveness of the AlphaReturn Blood Management System when used with the AlphaVac F1885 Multipurpose Mechanical Aspiration $(MMA)$ System in patients with acute intermediate-risk pulmonary embolism (PE). The company previously received FDA Breakthrough Device designation for the AngioVac System for this indication, providing an accelerated regulatory pathway and enhanced collaboration with the agency.

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