Johnson & Johnson (JNJ) on Wednesday announced that the FDA granted its De Novo authorization for the company’s soft tissue robotic system, Ottava, to handle multiple procedures in general surgery.
The marketing authorization allows Ottava's use in soft tissue procedures such as Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, and small bowel resection, according to the company.
Ottava is the first table-integrated soft tissue robotic system in the world, the New Jersey-based healthcare giant said, adding that it will roll out the product for a select group of U.S. customers in due course.
In parallel, the company plans to expand Ottava’s use for other procedures and seek its approvals in additional jurisdictions. JNJ's U.S.-based clinical trial for Ottava in inguinal hernia procedures is currently underway.
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