News & Views

What is the latest in Robotic Technology? What is in development? What is new to market?

Whenever the next and newest Laparoscopic instrumentation enters the market, it is the result of many years (decades even) of research and development to bring it from an idea through the necessary series of prototype developments and testing, approval by the FDA for indicated uses and finally professional education and training of end-users. It is potentially a highly profitable endeavor but equally costly, competitive and....with a never certain promise of surgeon adoption.

This is true of the plethora of robotic platforms that are at various stages along the product pipeline. Intuitive's recent rollout of its Davinci 5 belies a host of soft tissue robotic surgical innovations that deserve review and consideration. A projected doubling of the robotic surgical market over the next ten years is testament to the power of competitive innovation. While mention is made of platforms that are indicated for Orthopedic, Neurosurgery etc., the focus of this review will be on those platforms that are directed towards "soft tissue" surgery eg. Gynecology, General Surgery including Robotic assisted laparoscopic, hysteroscopic, endoscopic and cystoscopic approaches.

This summary uses data provided in a robotic surgery market analysis by MassDevice written by Chris Newmarker and Danielle Kirsh.

The following Companies (with attached links or websites) are reviewed.

CMR SURGICAL (Cambridge, UK)

The Versius robotic platform utilizes an "open" console-driven, mobil (easily moved around and between OR's) modular (ie one instrument arm for each separate wheeled mount) with individual laparoscopic instrumentation that demonstrates a 710° range of motion. The video camera leverages High Definition 3D vision technology and supports ICG imaging. Several advantages are suggested by the "open" console - where the operator is not working from a static position allowing for freedom of movement. Likewise, the laparoscopic instrumentation fits to the surgeon's trocar placement choice.

Having achieved approval for the indication of Cholecystectomy by Brazil's equivalent of the FDA (ANVISA), CMR was granted FDA Marketing clearance through 501(k) in October 2024. CMR notes that globally, Versius is the second most utilized surgical robotic system, with over 26,000 surgical procedures completed across Europe, Latin America, Asia, Middle East and Africa.

Its published price point is comparatively favorable: between $.75 mil to $1 mil.

https://us.cmrsurgical.com

DISTALMOTION (Epilange, Switzerland)

Reportedly having been used on over 1500 cases, the Dexter robot features an individual modular system likewise with an "open" console but one that is also a sterile field allowing surgeons easy transition between operating console and bedside. Dexter has the usual and necessary variety of fully wristed instruments albeit single use. Dexter does not use a Distalmotion's own proprietary video system rather it supports the use of standard laparoscopes and camera systems (ie a robotic arm-mounted 5mm or 10mm scope).

Dexter received de novo FDA Marketing Authorization in October 2024 having now been used in over 1500 cases across the full variety of soft tissue surgical specialties: General Surgery, Bariatrics, Gynecology, Urology and Colorectal.

https://www.distalmotion.com

INTUITIVE SURGICAL (Sunnyvale, CA)

It goes without saying that Intuitive's DaVinci was the first robotic platform on the market with a 30 year lead that has not dampened its innovation. With its 2024 rollout of the da Vinci 5, they have indeed "widened the moat".

The Da Vinci line of robotic platforms for soft tissue applications (General surgery, bariatric, cardiac, colorectal, gynecologic, head and neck, thoracic, urologic) are as well-known as its price point with surgical outcomes advantage over straight stick applications in only a handful of surgical settings.

The da Vinci 5 is considered "the company's most advanced robotic surgical system":  Force Feedback technology for tactile sensation, 4K, 3D visualization, increased arm reach and flexibility, and enhanced automation capabilities as a only a few of the 150+ design improvements. It's price point is apparently $2 Million to $2.5 Million.

While 5 may be its new flagship, there are the prior platforms to consider:

da Vinci Si

This platform was effectively discontinued in 2018 with cessation of new sales and of its service agreements. Continued wristed instrumentation sales are generally to be found on the secondary market.

da Vinci X

The da Vinci X is a surgical robotics system Intuitive designed as an entry point
for minimally invasive surgery programs. It has the same arm architecture, vision cart, and surgeon console as the da Vinci Xi, allowing for the standardization of instruments and technologies across the da Vinci robotic models.

da Vinci Xi

The da Vinci Xi is a multiport robotic surgical system. It has advanced instrumentation, 3DHD vision, Firefly fluorescence imaging, and integrated table motion for minimally invasive procedures across multiple specialties.

da Vinci SP

Intuitive's da Vinci SP is a single- port robotic surgical system
that delivers an articulating 3DHD endoscope and three wristed instruments through a single port. It gives surgeons 360-degree anatomical access.

Ion

With application approval for bronchoscopic lung biopsies, the Ion boasts an ultrathin maneuverability catheter with "shape-sensing technology" that allows for small nodules in the periphery even of all 18 lung segments.

JOHNSON & JOHNSON MEDTECH (New Brunswick, NJ)

Ottava

In November 2024, J&J received what is called Investigational Device Approval for its Ottava system meaning that it can establish clinical sites for conducting clinical trials. These are planned for 2025. The OTTAVA system features four, low-profile robotic arms that are incorporated into the OR table and are stowed underneath. This "unified architecture " is intended to provide a space-efficient footprint. As well the design includes the advantage of "twin motion" meaning that the movement of the table and of the robotic arms can be coordinated thereby simplifying patient repositioning and changes of quadrant access without re-docking.

In development still, the Ottava platform nevertheless will leverage Ethicon's extensive expertise in laparoscopic hand instrumentation.

Less relevant to soft tissue indications not least Gynecology, the following platforms are also part of the J&J Portfolio.

Its knee, hip and spine Orthopedic portfolio and bronchoscopic/endourologic system are not discussed here: Velys and Monarch respectively.

https://thenext.jnjmedtech.com/surgical-robotics

LEVITA MAGNETICS (Mt View, CA)

Mars Surgical System

Through FDA 510(k) application, the MARS Surgical System achieved FDA approval in 2023, indicated for trans-abdominal and surgery, over 500+ surgeries have been performed using the  magnetic technology. Of note it was also used in a proof of concept in coordination with the DaVinci single port platform.

Levita Magnetics' MARS system uses proprietary Dynamic Magnetic Positioning technology for robotic laparoscopy procedures. The technology leverages an extra corporeal magnet which then can direct movement intra-corporeal instrumentation. According to the company, it thereby reduces the number of incisions resulting in less pain, minimal opioid use, faster recovery, and reduced scarring.

https://www.levita.com

MEDICAL MICRO INSTRUMENTS (Jacksonville, FLA)

Symani Surgical System

With FDA de novo approval (de novo meaning that the technology, being of a totally new and different technology thereby lacking a precedent technology by which safety and efficacy can be implied), the Symani Surgical Systems was indicated for microsurgery and super-microsurgery allowing for highly magnified visualization and ultra-fine precision control of movement. An example of use would be in post-cancer reconstruction and lymphedema, by improving accuracy in delicate procedures involving the smallest blood vessels.

https://www.mmimicro.com/our-technology/symani-surgical-system/

MEDICAROID (Kobe, Japan)

Currently in development the Hinitori platform features a single boom with four robotic arms but with a much smaller space/volume footprint and therefore greater agility in the OR than the DaVinci Xi. With this agility and adding to its appeal, the system is likewise touted as being docking-free. With a regulatory application for use in Respiratory, Urology, Gastroenterology and Gynecologic surgery, it could have wide utility.  

https://www.medicaroid.com/en/

MEDTRONIC (Minneapolis, MN/Galway, Ireland)

Hugo RAS

After its unveiling in 2019, Hugo RAS has achieved CE mark in Europe and Health Canada with indications for Urology. It recently applied for FDA approval for urology procedures as well as for hernia repair, General Surgery and for Gynecology.

Of note, Hugo is a modular, multi- quadrant platform designed for various surgical procedures. Like most other robotic technology, it features wristed instruments and 3D visualization. Its two lens technology (like Olympus's Endo Eye) requires 3D glasses, providing for the most accurate depth perception critical to seeing anatomic relationships in the retroperitoneum. Its "modular" technology (meaning each individual arm is mounted on its own portable functional base) likewise provides significant instrument agility including "four quadrant" access.

Personally, having worked on the robot myself, it cannot come too soon to the US market.

https://www.medtronic.com/en-us/healthcare-professionals/specialties/surgical-robotics/robotic-assisted-surgery.html

MOMENTIS SURGICAL (Yehuda, Israel)

Anovo Surgical System

Having received FDA approval in 2024 with indications for Gynecology (hysterectomy, salpingectomy, oophorectomy), the Anovo system features 2  with robotic arms that can achieve an almost 180degree angulation at the "elbow" along with a "wrist" movement. As such, it is used through a transvaginal (posterior colpotomy) access port monitored laparoscopically however through traditional umbilical placement. It is a quintessential vNotes Robotic platform.

https://www.momentissurgical.com/anovo-surgical-system/

MOON SURGICAL (Paris, FR/San Carlos, CA)

Maestro

Having received both CE mark and 501(k) regulatory clearance for marketing in both the EU and in the US, and following use in over 1000 cases, the Maestro system is effectively a "first assist" system with two arms mounted on one mobile base. According to the company,  Maestro easily "integrates into existing clinical workflows" with the promise of improving OR efficiency and "allowing for alternative labor models": thank you AI.

https://moonsurgical.com

ROB SURGICAL (Barcelona, Spain)

Bitrack

With experience now in over 30 cases, the Bitrack is an "open platform" (ie compatible with almost all OR technology eg. existing port access, existing 2D or 3D laparoscope visualization - necessarily with 3D glasses - existing ESU's etc. The platform however supports only one-time use instrumentation. With anticipated indications for Urology and Gynecology, The Bitrack is touted as potentially being an affordable entry level robotic alternative.

https://www.robsurgical.com/bitrack-system/

RONOVO SURGICAL (Shanghai, China)

Carina

Currently in development in China, The Carina platform provides a modular system (ie. one instrument per mobile base with an operating console) seeks indication for use across multiple specialties: urology, gynecology, general surgery, and thoracic surgery. The company touts its development strategy: done "in collaboration with veteran laparoscopic and robotic surgeons around the world. It addresses numerous clinical pain points in minimally invasive surgeries with robust clinical performance and compelling economics."

Like other modular systems - eg. Hugo RAS - the system’s adaptability into existing surgical workflows apparently "makes it accessible to more clinicians and simplifies the learning curve."

https://www.ronovosurgical.com

MICROPORT (Shanghai, China)

Toumai SP

This integrated single port robotic platform has achieved National Medical Products Administration approval in China (FDA equiv.) covering clinical uses across urology, general surgery and gynecology. It requires a 2.5 cm incision at the belly button, through which three snake-shaped instruments and a snake-shaped endoscope are inserted. This compact approach allows access into narrow spaces and intricate anatomical structures.

With recent regulatory approval in March, the Toumai SP system covers clinical uses across urology, general surgery, and gynecology. Given its small access requirements and instrument flexibility, it could be a natural for vNotes procedures.

https://microport.com/healthcare-professional/surgical-robots

SS INNOVATIONS International (Fort Lauderdale, FL)

SSI Mantra 3

Having achieved approval in India, Indonesia, Guatemala, Ecuador, Nepal, Sri Lanka, Philippines for indications across the spectrum of Cardiology, Gynecology, Urology , Gen. Surgery, Onco-surgery and for head and neck, "SS Innovations International Inc. aims to make advanced surgical technologies more accessible by offering a cost-effective solution for healthcare institutions". The system touts a modular (again one instrument for each mobile base) configuration, 3D and 2 D vision and monitor system (both 4K), open-console design with "superior ergonomics". Furthermore (not that I understand how machine learning informs the course and conduct of surgery that by its nature is so fraught with the unexpected, demanding new and creative responses) its functioning engages machine learning models to improve safety and efficiency during procedures.

https://ssinnovations.com/ssi-mantra/

US MEDICAL INNOVATIONS (USMI) (Takoma Park, Maryland)

Canady Robotic AI Surgical System

As a good example of robotic specialization the Canady Robotic AI Surgical System is the world’s first AI robotic system that delivers cold atmospheric plasma (CAP) which is a three-dimensional non-contact bioelectric pulse electromagnetic field. CAP selectively targets and kills microscopic tumor cells during surgery without damaging non-cancerous surrounding tissue. Further exemplification are the "key components of the Canady Robotic system are a Motorized Positioning Arm, Speech Recognition Canady Electrosurgical Generator known as ORLI™, Controller for CAP Devices, Robotic Assisted End Effectors which can be used in Open, Laparoscopic, Thoracoscopic, Endoscopic and Mini-invasive surgical procedures. The System also provides the surgeon with 10 degrees of freedom, Speech activation of the Robotic movements, AI Powered Software Programs, 3D Navigational Guided Surgical Planning, Advance Contour Tracking of the CAP Beam, Pre-Programmed CAP (Cold Atmospheric Plasma) Dosimetry data for selectively targeting 32 Cancer cell types." And that's a mouthful.

The instrumentation itself is described "as a fully articulating, 5 mm handheld surgical instrument (the Flex Robowrist)." Apparently in parallel to its CAP instrumentation, it features a variety of more conventional laparoscopic tips: a hook, scissors, needle driver and dissector. The system offers three degrees of freedom and 360 degrees of rotation.

https://www.usmedinnovations.com

VICARIOUS SURGICAL (Waltham, MA)

Vicarious Surgical System

Currently in development, the Vicarious Surgical System is a single-port surgical robot that integrates miniaturized robotics, 3D visualization, and advanced sensing to enable minimally invasive surgical procedures. The Vicarious Surgical robot utilizes a single port requiring a 1.5 cm incision for the insertion of the camera and two robotic instruments. In miniature form, it places the swiveling double camera "eyes" and two jointed arms (shoulder, elbow and wrist) that together create an intracavitary robot, in a sense, virtually transporting surgeons inside the patient to perform procedures with greater dexterity, improved visualization, and enhanced sensing capabilities. Worth seeing the mechanism, this is the link to a video of the instrumentation.

vicarioussurgical.com

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VIRTUAL INCISION (Lincoln, NE)

MIRA

Currently engaged in human factors study as part of FDA application, MIRA (like the above Vicarious system) is a miniaturized robotic- assisted surgery (miniRAS) system placed entirely into the abdominal space through a single 3cm incision. With a compact design it weighs 2 lbs and is suspended above the patient and manipulated through a surgeon console. Of note Mira was demonstrated in a proof of concept task experiment aboard the space station.

virtualincision.com

VIRTUOSO SURGICAL (Nashville, TN)

VES (Virtuoso Endoscopy System)  

Virtuoso designed its system with two robotically controlled, needle-sized manipulators working from the tip of a rigid endoscope. Of note, smaller than current endoscopic technology, the Virtuoso scope is less than half the diameter of a U.S. dime with the manipulators 1 mm in diameter. This micro sizing is possible due to parallel bundled nano-tube technology; the manipulators, made of curved nitinol tubes, can bend, twist, and extend telescopically. Currently in development are applications to cystoscopy as well as hysteroscopy and endoscopy.

https://virtuososurgical.net

Since the advent of the DaVinci robot, the technology has been moving to smaller, more agile and versatile, and hopefully competitive on price. It is a fast moving and fast changing environment worth keeping an eye on and definitely getting your hands on if only in trial.

Cheers.

Kip (Malcolm Mackenzie,MD)  

Do you know who this is?

More information on John Sampson, MD:

“Sampson’s Theory” - have you ever wondered what Dr. John Sampson actually wrote regarding Retrograde Menstruation as the origin of Endometriosis? Its not what you thought!

Given that endometriosis is increasingly considered a “disease treated by excision”, it is perhaps worthwhile to review the endometriosis origin paradigm of retrograde menstruation that would argue the disease is both chronic and untreatable.

The Authors Conclusions are Not Supported by the Data Provided: a critical review of John Sampson's 1927 landmark study on the origin of endometriosis.

 Perhaps Dr. John Sampson can be considered the grandfather of endometriosis treatment; his concept of retrograde menstruation is central to endometriosis management and treatment effectively unchanged over the century since 1927. For the most part unchallenged, Dr. Sampson's theory of the origin of endometriosis has enjoyed an unusual amplification and elevation to being "the most popular - if not flawed - of theories".1

I believed and based my early practice of ObGyn on Sampson's theory because it is a pathophysiology of welcome simplicity that conveniently informs a surgical treatment that is right up my Gynecologist alley - hysterectomy and bilateral salpingo-oopherectomy; it fits perfectly. But after 20 years of completely excising endometriosis, I have found that women long-suffering from the disease actually achieve durable relief, actually get better. What an elegant concept: if I get rid of all the disease that is causing symptoms, then all the symptoms arising from the disease will resolve.

But this is not what Sampson's retrograde menstruation theory would have us understand. For me, this past 20 years of clinical outcomes from endometriosis excision has been in absolute contradistinction to what retrograde menstruation had suggested: that it is an incurable disease.

I am convinced that our flawed endometriosis treatment paradigms are based on a flawed origin paradigm.

 And so, with a more critical eye,  I reread Dr. John Sampson's 1927 landmark article describing "menstrual dissemination" as the source of endometriosis.  I wanted to evaluate his often cited first public argument for the origin paradigm of retrograde menstruation that still fully informs the treatment paradigms employed a century after. On its own terms from its own century, how strong is the original proof that Dr. Sampson provided indicating that the origin of endometriosis is indeed retrograde menstruation?

 Cited here is the original article, "borrowed" by Harvard University Widener Library  from the "lender" University of Hong Kong Libraries:

John A Sampson, MD. Peritoneal endometriosis due to the menstrual dissemination of endometrial tissue into the peritoneal cavity. American Journal of Obstetrics and Gynecology. 1927:14(4). pp 422-469.

Reviewers Comments:

Its a tough read: circular, repetitious with an overwhelming number of barely visible histologic photomicrographs and lots of very small-font footnotes (if you think pathology slides for an hour at a Grand Rounds is tough, try the article). All of the difficulty of actually reading the paper aside, he provides summary conclusions - here provided in his own words:

To his first summary point, his histologic finding of "embolic" menstrual tissue in uterine venous sinuses following hysterectomy and “venous injections” is the sole evidence provided for menstrual dissemination of endometrial tissue. Curiously, actual retrograde menstruation is not demonstrated nor discussed in his histologic study.

To his second point that menstrual blood contains menstrual tissue, he provides only histologic evidence of menstrual tissue within endometriomas and as above, as emboli in uterine venous spaces. He does not identify in his landmark paper that menstrual tissue is found in retrograde trans-tubal dissemination.

To his third point, that the endometrial tissue is found to be viable and that it "grows if transferred to situations favorable to its existence", he provides the following: "If endometrial tissue disseminated by menstruation is "thrown off to die" and is either actually "dead or dying," as has been so emphatically stated by Novak, (4) that phase of the implantation theory is likewise just as dead. If endometrial tissue disseminated by menstruation is sometimes alive and capable of growing, if transferred to suitable situations, we might expect to find embolic lesions of this tissue in the vessels of the uterine wall and even outside of that organ." 

Setting this presence of embolic lesions as the standard of proof of both the sustained viability of menstrual tissue and its capacity for implantation growth, Sampson reports on two patients on whom he performed hysterectomy on their second menstrual day wherein "An embolic or metastatic growth of endometrial tissue was found in a venous sinus of one uterus and many such lesions in the other uterus." Two patients with findings of either an embolic or metastatic phenomenon in the vessels of the uterine specimen - that was his proof of the viability of the menstrual tissue and proof of its capacity for implantation. The representative logic statement he makes is as follows: if one assumes A gives rise to B then finding B proves A gives rise to B.  It is a false logic, gross assumption without proof.

To his fourth point that peritoneum and ovary are suited to the growth of endometrial tissue, he provides a most flawed argument. He uses his clinical finding of endometriosis on "the appendix, cecum and loops of the small intestine, and their mesenteries" as proof that those peritoneal surfaces are suitable for implantation by far errant menstrual tissue. He also identifies capacity for cancers to grow on the peritoneum and on the ovary as proof that the "visceral and parietal peritoneum is suited to the growth of endometrial tissue."  It is an assumption with no proof.

To his fifth point that "the lesions of peritoneal endometriosis often occur in locations and under conditions indicating (or at least suggesting) their origin from menstrual blood escaping from the above mentioned sources" (again into venous spaces and emanating from endometrioma rupture), he again makes assumption without any proof.

 And finally, to his sixth and final point, that the peritoneal reaction to the menses-displaced endometrial tissue looks, on histologic sections, like the peritoneal reaction found in carcinomatosis is certainly not proof of the retrograde menstrual endometrium finding "surfaces suited to growth."

In review of the landmark paper published a century ago that established retrograde menstruation as the origin of endometriosis, critical peer review would certainly have generated the following Reviewer Response: "The Authors conclusions are not supported by the data provided."

To use Dr. Sampson’s own words, “the implantation theory is quite dead.”

Malcolm Mackenzie, MD

Next: “A flawed origin paradigm begets a flawed treatment paradigm: an argument for excision”

An excellent monograph on endometriosis published by APGO (American Professors of Gynecology and Obstetrics) is a must read.

Click the link below..