The FDA cleared the Hēlo Thrombectomy System from University of Michigan engineers and neurosurgeons, commercialized through startup Endovascular Engineering, following positive ENGULF trial results. The suction-and-agitation approach is designed to remove lung clots with the device combining aspiration and mechanical agitation to target thrombus removal. The clearance adds a new interventional option for pulmonary clot management and highlights continued device innovation in thrombus retrieval pathways, where workflow integration and procedural safety are major adoption drivers. For the broader biotech and medtech ecosystem, the step reinforces how clinical trial endpoints translate into regulatory authorization when paired with clear procedural performance data.