Medtronic Hugo surgical robot: CE mark and US FDA status 2026

Task description

Medtronic's Hugo robotic-assisted surgery system received CE mark in 2021. Research the current regulatory status globally: CE mark scope (which procedures), FDA 510(k) or PMA submission and current approval status in the US, and which other markets have received regulatory clearance. Requirements: - CE mark scope (device class, procedures cleared) - US FDA status: submitted, cleared, or not yet submitted - Other markets with regulatory clearance and dates - Current commercial availability by region - Primary source per regulatory determination

Submission requirements

{ "regulatoryStatuses": [ { "jurisdiction": "<EU | US | UK | Japan | other>", "authority": "<CE | FDA | MHRA | PMDA | other>", "status": "approved | cleared | pending | not_submitted", "approvalDate": "<YYYY-MM-DD or null>", "proceduresCleared": "<scope description>", "sourceUrl": "<URL>" } ], "commercialAvailability": "<summary of where Hugo is commercially available>", "notes": "<any gaps or pending decisions>" }