Senhance

[commercial]

surgical · food-service · 3 deployments in catalog

Field Advisory

Verified: Asensus Surgical (formerly TransEnterix; Durham NC; was NYSE American: ASXC) made the Senhance laparoscopic robot, FDA-cleared via 510(k) in Oct 2017 with subsequent clearances/indication expansions. Senhance is a genuinely cleared, commercial (if low-volume) product., Current status: ACQUIRED by Karl Storz (the headline): Karl Storz acquired 100% of Asensus, closing Aug 22 2024 at $0.35/share (~$95M total, ~67% premium); the stock ceased trading on NYSE American at close (delisted; now a private Karl Storz subsidiary). The canonical big-medtech-acquires-struggling-robotics-startup datapoint: a former public-market name sold for a fraction of its historic enterprise value. maturityStage=commercial (Senhance is cleared + still a product line); company status=acquired; lifecycleState=active (Senhance line continues under Karl Storz)., LUNA = research: The next-gen LUNA (real-time 'clinical intelligence' + cloud ML) was NOT FDA-submitted / NOT cleared / NOT for sale as of the Aug 2024 close. Karl Storz had targeted 2025 FDA - that target is unverified as met. LUNA = research-tier; current status under private-owner Karl Storz is not publicly traceable (cap-flag)., AI-substance + claimed-not-verified: Cleared 'digital surgery' substance = machine-vision/digital-laparoscopy assists (real but incremental, not autonomy); 'Performance-Guided Surgery' framing oversold vs what's cleared. NOT verified: LUNA FDA submission/clearance ever occurring; current Senhance installed-unit count (Karl Storz private); whether Senhance is actively commercialized vs wound down under Karl Storz.

Manufacturer

Asensus Surgical

Form Factor

surgical

Lifecycle

commercial

Operational Reality

Audited

Deployments

3

Target Price

Custom Quote

  • SURGICAL
  • COMMERCIAL

Description

Asensus Surgical, formerly TransEnterix and based in Durham, North Carolina, was a public company on the NYSE American as ASXC that made the Senhance multi-port laparoscopic robotic system, FDA-cleared via 510(k) in October 2017 with subsequent instrument and indication clearances, making Senhance a genuinely cleared if relatively low-volume commercial product. The headline current-state fact is that Karl Storz acquired the company, closing on August 22, 2024 at $0.35 per share for about $95 million, a roughly 67 percent premium, with the stock ceasing to trade on the NYSE American at close, leaving Asensus a private Karl Storz subsidiary; this is the canonical example of a large medtech company absorbing a struggling robotics startup for a fraction of its historic enterprise value. The registry records Senhance at commercial maturity with an active lifecycle, since it remains a cleared product line continuing under Karl Storz, while the company status is recorded as acquired. The company's next-generation LUNA system, unveiled in February 2023 with claimed real-time clinical intelligence and cloud machine learning, was not FDA-submitted, not cleared, and not for sale as of the August 2024 close, so LUNA is recorded at research maturity, with a 2025 FDA target that is unverified as met and a current status under private ownership that is not publicly traceable. On AI substance the cleared digital-surgery features are machine-vision and digital-laparoscopy assists that are real but incremental rather than autonomy, and the Performance-Guided Surgery framing was oversold relative to what is cleared.

Key facts & specs

16 entries
website
https://www.globenewswire.com/news-release/2024/08/22/asensus-surgical-karl-storz-closing
maturity
commercial
lifecycle
active
manufacturer
Asensus Surgical
deployments count
3
Maturity stage
commercial
Products
Senhance: FDA-cleared multi-port laparoscopic robotic system (initial 510(k) Oct 2017 as TransEnterix; later 3mm instruments, ultrasonic, indication expansions, machine-vision clearance). LUNA: next-gen system (unveiled Feb 2023) with claimed real-time clinical intelligence + cloud ML; NOT FDA-submitted/cleared, NOT for sale.
Form Factor
surgical (multi-port laparoscopic teleoperated robotic system with machine-vision/digital-laparoscopy assists)
Fda clearance
October 2017
Clearance body
FDA
Procedure types
multi-port laparoscopic
Acquisition price
$0.35 per share (~$95 million total)
Acquisition close date
August 22, 2024
F D A clearance date
October 2017
L U N A unveiling date
February 2023
L U N A F D A target
2025

Safety record

Safety Status
Zero incidents on record

2 recalls on record (2 critical). Most recent: Sep 2023.

Risk Metrics
Incidents: 0
Recalls: 2
Latest: Sep 2023
critical: 2

Hardware architecture

1 entry
  • Senhance Instrument ArmACTUATOR[Safety Critical]
    (primary safety)

    Instrument arm

FAQ

13 entries
What is Senhance?

Asensus Surgical, formerly TransEnterix and based in Durham, North Carolina, was a public company on the NYSE American as ASXC that made the Senhance multi-port laparoscopic robotic system, FDA-cleared via 510(k) in October 2017 with subsequent instrument and indication clearances, making Senhance a genuinely cleared if relatively low-volume commercial product. The headline current-state fact is that Karl Storz acquired the company, closing on August 22, 2024 at $0.35 per share for about $95 million, a roughly 67 percent premium, with the stock ceasing to trade on the NYSE American at close, leaving Asensus a private Karl Storz subsidiary; this is the canonical example of a large medtech company absorbing a struggling robotics startup for a fraction of its historic enterprise value. The registry records Senhance at commercial maturity with an active lifecycle, since it remains a cleared product line continuing under Karl Storz, while the company status is recorded as acquired. The company's next-generation LUNA system, unveiled in February 2023 with claimed real-time clinical intelligence and cloud machine learning, was not FDA-submitted, not cleared, and not for sale as of the August 2024 close, so LUNA is recorded at research maturity, with a 2025 FDA target that is unverified as met and a current status under private ownership that is not publicly traceable. On AI substance the cleared digital-surgery features are machine-vision and digital-laparoscopy assists that are real but incremental rather than autonomy, and the Performance-Guided Surgery framing was oversold relative to what is cleared.

Is Senhance actually deployed in the real world?

Yes. Senhance is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.

Is Senhance autonomous or teleoperated?

Not verified as fully autonomous. Senhance's capabilities on the DEPLOY registry are recorded as teleoperated-assisted, demonstrated-only, or vendor claims (Assists surgery), not independently confirmed to run without a human in the loop.

Who makes Senhance?

Senhance is made by Asensus Surgical, based in Durham, NC, founded in 2006.

Where is Senhance deployed?

3 verified deployments of Senhance are on the DEPLOY registry, including at Japan, United States, European Union.

Can you buy Senhance?

Senhance is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.

Is Senhance FDA cleared?

Senhance has 3 regulatory records on the DEPLOY registry: FDA recall, recalled; FDA 510(k) clearance, cleared; FDA 510(k) clearance (K171120), cleared. See the Regulatory filings section for each agency source.

What are alternatives to Senhance?

On the DEPLOY registry, comparable surgical robots to Senhance include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Stryker Mako SmartRobotics.

How does Senhance compare to da Vinci (and Ion)?

Senhance and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. Senhance has 3 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.

Is Senhance a top surgical?

On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Senhance ranks in roughly the top 50% of surgical models tracked by the registry.

What is Senhance's maturity stage?

Senhance is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.

Is Senhance safe?

Senhance has 2 active incidents on record in the DEPLOY registry. 2 recalls on record (2 critical). Most recent: Sep 2023. Retracted incidents are excluded from this count.

What is the Asensus Senhance surgical robot?

The Asensus Senhance is a robotic surgical system that empowers surgeons with real-time insights. The FDA issued a Class I recall (the most serious type) for the Senhance system due to malfunctions causing unintended movement. Class I recalls may cause serious injuries or death.

Deployments

3 entries

Incidents affecting Senhance

1 entry

Sectors & applications

1 entry