PR Newswire BiotechOriginal article
E2 Secures Dual FDA Clearances for the Hēlo® Platform, Introducing a PE Thrombectomy System with Integrated Blood Return
RegulatoryapprovedHēlo® Thrombectomy SystemHēlo ReturnPositive
AI Analysis
Summary
Endovascular Engineering secured dual FDA 510(k) clearances for its Hēlo Platform, comprising a PE thrombectomy system and integrated blood return device, establishing the first platform compatible with continuous vacuum aspiration.
Outcome Details
Dual FDA 510(k) clearances for Hēlo Thrombectomy System and Hēlo Return platform
Importance:7/10
Sentiment:
0.85
FDA Clearance510(k)Medical DeviceThrombectomyPulmonary EmbolismRegulatory Approval
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Published by PR Newswire Biotech on October 12, 2026 5:36 PM