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Incident · Regulatory action

FDA grants De Novo marketing authorization to J&J Ottava surgical robot

On July 22, 2026, the FDA granted De Novo marketing authorization to Johnson and Johnson MedTech for its Ottava robotically-assisted surgical system, clearing the company to enter the US soft-tissue robotic surgery market. Ottava integrates robotic arms into the operating table, reducing footprint by 30-50 percent versus conventional cart-mounted systems. J&J plans a phased commercial launch with clinician training.

Occurred 2026-07-22 · Johnson & Johnson Ottava at California · Johnson & Johnson · California · Surgical robots · Investigated by FDA

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Sources (1)

  1. Reuters · https://www.reuters.com/business/healthcare-pharmaceuticals/johnson-johnsons-robotic-surgery-device-gets-us-fda-marketing-authorization-2026-07-22/ · 2026-07-22

Status history

  • Active · 2026-07-23 · agent:recon

Common questions

What happened in FDA grants De Novo marketing authorization to J&J Ottava surgical robot?
On July 22, 2026, the FDA granted De Novo marketing authorization to Johnson and Johnson MedTech for its Ottava robotically-assisted surgical system, clearing the company to enter the US soft-tissue robotic surgery market. Ottava integrates robotic arms into the operating table, reducing footprint by 30-50 percent versus conventional cart-mounted systems. J&J plans a phased commercial launch with clinician training.
When did this incident occur?
The incident is recorded as occurring on July 22, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA grants De Novo marketing authorization to J&J Ottava surgical robot?
Johnson & Johnson Ottava by Johnson & Johnson is the recorded robot involved in this incident at California.
Has anyone responded to FDA grants De Novo marketing authorization to J&J Ottava surgical robot?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA grants De Novo marketing authorization to J&J Ottava surgical robot?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (no primary) · last reviewed 2026-08-21

Verification posture

Verified

Medium confidence

Review state

Stable

Last reviewed 2026-08-21

Sources by quality tier

1
secondary-established-publication
Established publication

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA grants De Novo marketing authorization to J&J Ottava surgical robot.

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Canonical ID 0ef151fe-51d8-4706-af5e-37116f8cfd74