IRRAflow Clearance Now Includes Bedside Monitor Software

The FDA has granted 510(k) clearance to permit data transmission to the hospital’s bedside monitor for IRRAS’ next-generation IRRAflow control unit, which combines automated irrigation, drainage and monitoring of intracranial bleeds.

The system received its initial FDA clearance in April 2020.

The software-controlled system uses a multichannel catheter to deliver drugs, evacuate fluid collections and manage intracranial pressure.

The company aims to expand the system’s potential indications to include abdominal abscesses and blood clots.