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Asensus Surgical ISU

by KARL STORZ

Last verified

Senhance robotic laparoscopy system with machine-vision camera control (ISU), owned by KARL STORZ since August 2024.

At a glance

Pricing
No public price. Capital equipment. No price source found.
HIPAA
Not disclosed
SOC 2
Not disclosed
EHRs
—
Founded
—
On this page

Independent score  ·  By our public rubric

18/100Tracked
How it’s computed →
  • Regulatory & Compliance
    18/28

    FDA cleared (14 K-numbers on record)

  • Clinical Integration
    0/26

    No EHR integrations listed

  • Evidence Strength
    0/28.8

    No peer-reviewed coverage

  • Vendor & Market
    3/18

    Seed-stage or unfunded

  • Sentiment & Transparency
    0/14

    No clinician sentiment data available

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance18/18

    FDA cleared (14 K-numbers on record)

  • HIPAA / SOC2 / BAA0/10

    No public HIPAA/SOC2/BAA attestation

Clinical Integration

  • 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

Evidence Strength

  • Peer-reviewed papers0/21

    No peer-reviewed coverage

  • RCT / meta-analysis / systematic review0/8

    No RCT, meta-analysis, or systematic review

Vendor & Market

  • Funding & adoption signal3/12

    Seed-stage or unfunded

  • Years in market0/6

    Founded year not recorded

Sentiment & Transparency

  • Clinician sentiment (Reddit)0/9

    No clinician sentiment data available

  • Pricing transparency0/5

    No public pricing

Scored October 15, 2026 · Public scoring method v1.1.0

Bottom line

Senhance robotic laparoscopy system with machine-vision camera control (ISU), owned by KARL STORZ since August 2024.

No public price. Capital equipment. No price source found.

Editorial review  ·  By MedAI Verdict

Bottom line

Senhance is a robot-assisted laparoscopy system, and the Intelligent Surgical Unit (ISU) is the machine-vision layer Asensus added to it. KARL STORZ has owned the line since August 2024. No price is public. The FDA's 510(k) records show clearances from October 2017 to May 2026. The fit is a hospital surgical program evaluating a laparoscopic robot with camera automation and on-screen measurement.

Who owns Senhance now?

KARL STORZ closed its acquisition of Asensus Surgical on 22 August 2024 at $0.35 per share in cash, according to The Robot Report. MassDevice reported that Asensus was delisted from NYSE American as part of the deal, which followed an April 2024 letter of intent and a merger agreement announced in June 2024.

Asensus was the renamed TransEnterix. The FDA's 510(k) records show the applicant name changing from TransEnterix to Asensus Surgical between 2020 and 2021. Asensus was based in Research Triangle Park, North Carolina, and asensus.com now redirects to the KARL STORZ site.

What does Senhance do, and what is ISU?

An Asensus release from September 2021 describes ISU as a real-time image-analytics layer with machine-vision camera control, 3D measurement, digital tagging and image enhancement. The surgeon steers the camera's field of view with the instruments. The same release gives millimetre-level measurement as the headline capability, with hernia mesh sizing and staple-line planning as the examples. Asensus called these the first machine-vision features for soft-tissue abdominal surgery, which is the company's own claim.

Medical Device Network reported a CE mark for the expanded ISU capabilities, making them available in the EU and Japan. At the time of the sale Asensus was developing a next-generation system called LUNA, which was not cleared.

What has the FDA cleared?

Six 510(k)s sit under the Asensus Surgical name, all in product code NAY:

  • K211325, July 2021, Senhance Surgical System
  • K212054, August 2021, Senhance Surgical System
  • K220889, May 2022, Senhance Surgical System
  • K223095, March 2023, Senhance Surgical System
  • K233866, July 2024, Senhance Surgical System
  • K254192, May 2026, Senhance Ultrasonic System

Under the TransEnterix name there are earlier Senhance entries, starting with K171120 in October 2017 and continuing through K202166 in March 2021. K212054 was decided on 30 August 2021, two days before the Asensus release announcing the ISU expansion. MassDevice reported in mid-2024 that Senhance indications had grown to adult and pediatric urology, the same month as K233866.

The newest entry, K254192 in May 2026, is an ultrasonic system still filed under the Asensus Surgical name, almost two years after the acquisition closed.

How is Senhance priced?

No price for Senhance is public.

Who is it for?

A hospital surgical program weighing a laparoscopic robot, particularly one interested in surgeon-steered camera control and intraoperative measurement for work such as hernia mesh sizing. Buyers now deal with KARL STORZ, since the Asensus website redirects there.

A hospital with no laparoscopic surgery program has no use for it.

The verdict

Senhance has a long run of FDA clearances, and ISU adds camera automation and measurement to it as described in Asensus's 2021 release. It suits a laparoscopic surgery program that wants to evaluate those two features on a robot.

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.

Pricing

What it costs

All tiers are custom-quoted. The vendor does not publish per-provider list pricing.

TierMonthlyAnnualNotes
Quote only——No public price. Capital equipment. No price source found.

Source: vendor pricing page. Last checked October 15, 2026.

Compliance + integration

What deploys cleanly

Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

Vendor stability

Who builds it

It was previously known as Asensus Surgical, TransEnterix, an acquisition or rebrand that healthcare-AI buyers should track when reviewing prior independent coverage.