Johnson & Johnson (JNJ) has submitted to the US FDA a De Novo classification application for its OTTAVA robotic surgical system.
The company is seeking approval for mjultiple procedjures in the upper abdomen, such as gastric bypass, small bowel resection, and hiatal hernia repair.
J&J noted that OTTAVA has a unique unified architecture and future connection to its Polyphonic digital ecosystem.
The company added that it received permission for an Investigational Device Exemption study of OTTAVA for inguinal hernia procedures.
OTTAVA is seen as a potential competitor to Intuitive Surgical’s (ISRG) da Vinci surgical system.
