ARX: AROA secures first FDA clearance for ENIVO system
AROA BIOSURGERY LIMITED
- AROA Biosurgery received U.S. FDA 510K clearance for its Enivoâ„¢ pump and catheter, part of the Enivoâ„¢ Tissue Apposition Platform.
- The clearance simplifies initiating future clinical studies and early commercialization activities for the company.
- AROA’s management estimates the total addressable U.S. market for the Enivo™ platform to be greater than $1B.
2023-04-12 09:05:00