- No public price. Capital sale.
- Not disclosed
- Not disclosed
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Surgical AI
OTTAVA (J&J MedTech)
by J&J MedTech
OTTAVA, Johnson & Johnson MedTech's soft-tissue surgical robot (FDA De Novo, July 2026), with its Polyphonic digital layer.
On this page
25/100Niche fit
- Regulatory & Compliance18/28
FDA cleared (1 K-number on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength0/28.8
No peer-reviewed coverage
- Vendor & Market8.4/18
Mid-tier funding and adoption
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (1 K-number on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers0/21
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
OTTAVA, Johnson & Johnson MedTech's soft-tissue surgical robot (FDA De Novo, July 2026), with its Polyphonic digital layer.
No public price. Capital sale.
Bottom line
Johnson & Johnson MedTech documents OTTAVA, a soft-tissue surgical robot that received FDA De Novo authorization in July 2026, and Polyphonic, the digital layer that connects to it. OTTAVA is a capital purchase for hospital surgical departments and is launching with select U.S. customers. The vendor lists no price.
What has J&J MedTech announced?
Johnson & Johnson announced the authorization on 22 July 2026 from New Brunswick, New Jersey. The FDA record is DEN250068, dated 21 July 2026, product code SIR, with the applicant listed as "Auris Health, Inc., part of Johnson & Johnson." J&J submitted it on 7 January 2026, according to J&J and trade press. Authorization came through the De Novo pathway.
J&J describes OTTAVA as "the world's first table-integrated soft tissue robotic system... connected to the Polyphonic digital ecosystem." The authorized procedures are Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair. An inguinal hernia trial is under way.
What is Polyphonic?
J&J calls Polyphonic for OTTAVA "a secure digital solution designed to support surgical teams... bringing learning, media, and data-driven insights together," and an "open digital ecosystem." It is the digital layer that ships with the robot and is described alongside it in the same J&J release.
Which companies sit behind it?
Verb Surgical began as a J&J and Verily venture in 2015. J&J agreed to buy Verily's remaining stake on 20 December 2019, closing in the first quarter of 2020. Auris Health, which J&J acquired in 2019 in a deal reported at $3.4 billion, is the applicant on the OTTAVA record. The same applicant holds seven 510(k) records for robotic bronchoscopy, from K193534 on 15 April 2020 to K260382 on 25 July 2026, a separate product line from the OTTAVA robot and from Polyphonic.
What do analysts say?
MedTech Dive reports that OTTAVA takes 30 to 50 percent less space than boom or cart systems. It also reports that the authorization rested on an FDA IDE study that began in late 2024. Analysts quoted by MedTech Dive doubt OTTAVA can gain ground on Intuitive's da Vinci soon. Medtronic received FDA clearance for its own soft-tissue robot in late 2025, which makes OTTAVA the second challenger.
The verdict
OTTAVA is a surgical robot with a regulatory authorization and a limited launch to select U.S. customers. Hospital surgical departments are the only buyers J&J describes, and the authorized procedure list above is the scope of that authorization.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | — | — | No public price. Capital sale. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA De Novo per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
Who builds it
It was previously known as J&J Digital Surgery, Verb Surgical, an acquisition or rebrand that healthcare-AI buyers should track when reviewing prior independent coverage.
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