FDA grants de novo classification for Early Bird Bleed Monitoring System

Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, announced that it has been granted de novo classification by the FDA for the Early Bird Bleed Monitoring System.

Saranas has developed a technology that allows for the early detection and monitoring of bleeding complications associated with vascular access procedures. The Early Bird Bleed Monitoring System includes a vascular access sheath with embedded sensors that measure the electrical resistance across the blood vessel. By sensing a change in the vessel’s electrical resistance, the Early Bird is designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as transcatheter aortic valve replacement, large bore hemodynamic support device placement, or other complex endovascular interventions, where the femoral artery or vein is used to gain vascular access. The technology was invented at the Texas Heart Institute.

Comment: Rapid detection of internal bleeding complications with the Early Bird may enable physicians to mitigate downstream consequences by addressing bleeding complications immediately, improving patient outcomes and lowering healthcare costs.