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# Saranas De Novo App Filed for Early Bleed Monitor
- URL: https://www.fdaweb.com/saranas-de-novo-app-filed-for-early-bleed-monitor/
- Published: 2018-04-25T12:00:00.000Z
- Updated: 2026-09-15T00:00:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141304

Saranas has filed a *de novo* classification for the Early Bird Bleed Monitoring System, a device for use during endovascular procedures to detect the onset of bleeding. The system uses a “vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as a transcatheter aortic valve replacement, large bore hemodynamic support device placement, or other complex cardiovascular interventions, where the femoral artery or vein is used to obtain vascular access,” the company says.