J&J's Ottava clears FDA de novo — a soft-tissue surgical robot built into the operating table

Johnson & Johnson's Ottava system, shown publicly on 25 July 2026, has FDA de novo authorisation — the pathway for a genuinely new device class rather than a me-too clearance. Four arms are integrated into the operating table itself and retract when unused; J&J says that layout takes 30-50% less room than boom-and-cart systems. It is cleared for nine general surgical procedures including gastric bypass, gastrectomy, cholecystectomy, appendectomy and hiatal hernia repair.

What it means Operating-room floor space is the constraint that keeps surgical robots out of smaller hospitals, so a table-integrated architecture is an access argument as much as an engineering one — and de novo means a regulator agreed it is a new class.