ASXC - Asensus wins FDA nod for Senhance surgical system for children
2023-03-20 07:39:14 ET
- Medical device company Asensus Surgical ( NYSE: ASXC ) added ~2% in the pre-market trading Monday after announcing that the FDA issued 510(k) clearance for its Senhance Surgical System for use in pediatric patients.
- The Senhance System, used in laparoscopic surgery, is already indicated for children in the EU and Japan.
- “Given the small size of the patients, pediatric surgery seeks to use the least invasive instruments and scopes, while maintaining a high level of precision and stability,” Asensus ( ASXC ) Chief Executive Anthony Fernando said.
- “The Senhance System is uniquely qualified to meet these needs of pediatric surgeons,” he noted, adding, “we look forward to bringing all of our learnings from over three years of performing pediatric procedures in Europe and Japan to the US.”
- Asensus ( ASXC ), formerly known as TransEnterix, won 510(k) clearance from the FDA for Senhance Ultrasonic System in 2019.
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Asensus wins FDA nod for Senhance surgical system for children