Verified Events
DateTypeCompanyHeadlineSegment
Medtronic adds FDA-cleared LigaSure vessel sealer to Hugo
- The instrument seals and cuts vessels, thick tissue and lymphatics up to 7 mm in diameter and is designed for the Valleylab FT10 energy platform.
- Hugo is currently cleared for urologic procedures in the United States; Medtronic is pursuing broader soft-tissue indications.
- The LigaSure RAS Maryland instrument had been introduced on Hugo in Europe in 2025 after CE marking.
eCential Op.n adds FDA-cleared PERLA TL robotic workflow
- FDA submission K261205 was cleared on July 29, 2026 and covers open, minimally invasive and percutaneous pedicle-screw procedures.
- The robotic reusable instruments couple Spineart PERLA TL screwdrivers and taps to a robotic adaptor for use in navigation or robotic-guidance mode.
- The cleared workflow is limited to Spineart implants included in the Perla by Spineart software and uses eCential’s separately cleared Op.n platform.
FDA clears DEXTER for ventral hernia repair
- The clearance expands DEXTER's U.S. label to the four highest-volume soft-tissue ambulatory procedure categories.
- Distalmotion reports that surgeons have used DEXTER in more than 4,000 patients.
- The system is designed for surgeon-controlled robotic assistance within established operating-room workflows.
ROEN Surgical receives FDA clearance for Zamenix P
- Zamenix is designed for flexible ureteroscopic treatment of kidney and ureteral stones using a patient-side robot and surgeon console.
- The platform remotely controls scope insertion, rotation and deflection together with laser and stone-basket instruments.
- ROEN described the clearance as the regulatory step enabling commercialization of the system in the United States.
LivsMed submits STARK surgical robot for Korean approval
- STARK applies LivsMed's articulating-instrument technology to modular robotic arms intended to fit existing operating rooms without major layout changes.
- Its instruments articulate by up to 90 degrees in multiple directions, extending the company from handheld laparoscopic tools into robot-assisted surgery.
- The system debuted in Korea in May and appeared at the Society of Robotic Surgery meeting in July before the approval submission.
MMI receives FDA approval to expand REMIND microsurgery study
- The supplement followed FDA review of 30-day safety data from the first patient cohort.
- REMIND evaluates Symani-enabled microsurgical techniques intended to re-establish deep-cervical lymphatic drainage in patients with Alzheimer's disease and confirmed lymphatic abnormalities.
- The study remains an early-feasibility investigation; Symani is not FDA-cleared for lymphatic reconstruction for brain disease.
FDA clears updated MONARCH Platform configuration
- The applicant is Auris Health, Inc. at its Santa Clara operating address.
- The filing covers MONARCH Platform configuration MON-000008.
- The FDA decision date was 25 July 2026.
OTTAVA receives US FDA De Novo authorization
- Authorization covers multiple upper-abdominal general-surgery procedures.
- OTTAVA coordinates four table-integrated robotic arms with synchronized table motion.
- A 30-patient pivotal gastric-bypass study completed every procedure robotically without conversion.
Zeta adds FDA-cleared robotic positioning to its TMS platform
- Robotic positioning dynamically tracks patient movement and adjusts the TMS coil to maintain alignment.
- The system was described as providing submillimeter-level positioning accuracy and setup in under a minute.
- Accuracy and usability testing involved Harvard Medical School and the University of Cambridge.
FDA records an open Class II recall for two Versius surgeon consoles
- The recall covers two V-SS-1020 consoles running Pratchett 1 version 62.1 that were distributed in California.
- The firm initiated the recall on June 9, 2026 and the corrective action is to notify customers and configure secure boot on the affected consoles.
- Updated instructions tell users to keep the system in a secure environment and inspect tamper-evident labels before use.
Microbot Medical receives first international LIBERTY marketing approval
- Israel became the second jurisdiction, after the U.S., to clear LIBERTY for marketing.
- The AMAR approval supports commercialization in Israel and a Free Sale Certificate for additional submissions.
- The approval supports Microbot Medical's path toward fielded use in maritime autonomy, underwater robotics or marine inspection workflows.
Sentire receives European CE Mark and Singapore HSA certification
- The European certification was issued under the Medical Device Regulation.
- Singapore Health Sciences Authority certification was obtained at the same milestone.
- Both certifications cover minimally invasive general, gynecological, thoracic and urological surgery and enable market access in Europe and Singapore.
Microsure receives CE mark approval for MUSA-3 microsurgery robot
- Microsure received CE mark approval for MUSA-3, enabling clinical use of the microsurgical robot in Europe.
- The approval moves MUSA-3 from product development into a clinical medical-device phase focused on evidence generation and adoption.
- Microsure said the next phase will focus on clinical evidence at leading European centres and partnerships for supermicrosurgical procedures.
Panda Surgical achieves ISO 13485 certification
- The certification covers the company's processes for medical-device safety, reliability and regulatory compliance.
- Panda is preparing a handheld robotic platform for minimally invasive neurosurgery.
- The quality system supports the company's planned clinical investigation and regulatory work.
Zeta Surgical receives FDA clearance for cranial navigation and instruments
- The instruments provide navigated guidance for catheter and shunt placement, brain biopsies and trigeminal rhizotomies.
- CT or MRI scans are aligned with patient anatomy using computer vision and artificial intelligence.
- A large commercial pilot with the Big 10 Neurosurgical Consortium was planned for 2026.
CMR Surgical submits Versius Plus 510(k) for benign gynecology
- The submission seeks clearance for benign procedures including total hysterectomy, oophorectomy and salpingectomy.
- CMR said the filing builds on global clinical experience and supports its U.S. market expansion.
- This is a premarket submission, not an FDA clearance; Versius Plus was previously cleared for adult cholecystectomy.
Pixee Medical announces CE mark for Knee+ NexSight
- More than 20 Knee+ NexSight procedures had been performed across France and Belgium at the time of the announcement.
- The CE mark followed early European clinical use of the handheld augmented-reality guidance workflow.
- The system supports real-time total-knee implant positioning without a large robotic console or disposable instrument package.
SS Innovations raises $18.6M private placement to expand surgical robotics globally
- SS Innovations disclosed an $18.6M private placement to support global sales of its SSI Mantra surgical robotic system.
- Proceeds are intended to support growth in India while preparing for market entry in the United States and European Union.
- The company had filed for FDA 510(k) clearance in December, with U.S. review expected to progress through 2026.
CUVIS-Spine receives COFEPRIS approval in Mexico
- COFEPRIS granted the approval.
- CUVIS-Spine guides and fixes pedicle screws.
- The system already had U.S. FDA and Korean MFDS approvals.
CMR Surgical receives CE and UKCA marks for Versius paediatric surgery
- The marks cover abdominal surgery in children and infants under 18.
- CMR said this was its first regulatory clearance for treating children.
- The release highlights Versius’ compact, modular design and small instruments for paediatric anatomy.
Johnson & Johnson submits OTTAVA robotic surgical system to FDA
- Johnson & Johnson MedTech submitted the OTTAVA robotic surgical system to the U.S. FDA.
- The submission was supported by data from the system's investigational device exemption study.
- The event marks a regulatory milestone after first clinical cases were completed in 2025.
Stereotaxis receives FDA approval for MAGiC ablation catheter
- The FDA approval covered the MAGiC Magnetic Interventional Ablation Catheter.
- MAGiC is navigated by computer-controlled magnetic fields.
- The catheter is designed for cardiac ablation procedures that treat heart arrhythmia.
FDA clears Versius Plus for adult cholecystectomy
- The clearance covers robotically assisted cholecystectomy in adults aged 22 and older.
- Versius Plus remains surgeon-controlled and uses modular bedside arm units with an open console.
- CMR said U.S. commercialisation would begin in 2026.
Medtronic receives FDA clearance for Hugo robotic-assisted surgery system
- Medtronic received U.S. FDA clearance for the Hugo robotic-assisted surgery system for urologic procedures.
- The clearance was supported by the Expand URO clinical study in multi-port robotic-assisted urological surgery.
- The decision brings Hugo into the U.S. soft-tissue robotic surgery market alongside Medtronic's broader surgical portfolio.
Zeta TMS Navigation System receives FDA 510(k) clearance
- Three-dimensional imaging and motion-aware tracking support coil alignment to planned brain targets during patient movement.
- The device is classified as a Class II stereotaxic instrument under 21 CFR 882.4560 and product codes SGE and QFF.
- Testing with Cambridge and Harvard collaborators reported sub-millimeter translational and sub-degree angular precision in bench, phantom and cadaver settings.
Medtronic starts U.S. Hugo RAS gynecology IDE study
- The Embrace Gynecology study became Medtronic’s third U.S. IDE clinical study for Hugo RAS.
- Medtronic said the study supported its strategy to pursue multiple U.S. indications for Hugo RAS.
- The approval supports Medtronic starts U.S. Hugo RAS gynecology IDE study's path toward fielded use in commercial automation and autonomous-system workflows.
CUVIS-joint THA receives Korean MFDS approval
- The approval covers CUVIS-joint THA.
- The indication adds hip procedures to the existing CUVIS-joint knee replacement robot line.
- The approval supports CUVIS-joint THA's path toward fielded use in maritime autonomy, underwater robotics or marine inspection workflows.
EndoRobotics receives FDA 510(k) clearance for ROBOPERA
- The FDA granted 510(k) clearance for EndoRobotics' ROBOPERA ER-R-002 and ER-R-003 devices.
- FDA records list the decision date as September 24, 2025 and classify the device under gastroenterology/urology with product codes FDF, FDS and NAY.
- The FDA summary describes ROBOPERA as a system intended to hold and lift tissue and mucosal membrane in the esophagus, stomach, colon and rectum during endoscopic surgical procedures.
Microbot Medical receives FDA clearance for LIBERTY endovascular robot
- Microbot Medical received FDA 510(k) clearance for the LIBERTY endovascular robotic system.
- The clearance moved LIBERTY from development into a regulated commercial pathway for endovascular procedures.
- The event anchors Microbot as a surgical robotics pure play with a cleared robotic system.
Surgerii Robotics receives CE mark for single-port surgical robot
- Enables use of system across European markets
- Expands into urology, gynecology, and thoracic procedures
- Supports global commercialization strategy
Stereotaxis receives FDA clearance for MAGiC Sweep catheter
- Stereotaxis received U.S. FDA clearance for MAGiC Sweep, a robotically steered endovascular guide catheter.
- The company described the clearance as its first FDA clearance for an interventional catheter in nearly 20 years.
- The milestone supports the company's robotic magnetic navigation profile with a cleared device update.
Toumai telesurgery system receives NMPA commercial approval
- The approval covered MicroPort MedBot's next-generation tele-surgical platform for operation across complex network environments.
- Toumai supports 5G, broadband, dedicated-fiber and satellite connections for one-to-many and many-to-many surgical links.
- The network had supported nearly 400 tele-surgical procedures and extended across six continents.
SS Innovations uplists to Nasdaq while scaling SSi Mantra surgical robotics
- SS Innovations announced its uplisting to Nasdaq under ticker SSII.
- The company positioned the listing around its SSi Mantra surgical robotic system and international commercialization plan.
- The event is a public-market milestone for a surgical robotics pure play.
LEM Surgical receives FDA clearance for Dynamis robotic surgical system
- Dynamis combines real-time imaging, dynamic guidance and adaptable instrumentation compatibility.
- The clearance opened access to the system for U.S. spine surgeons.
- LEM designed the platform to improve accuracy and control in navigation-based spine procedures.
Pixee Medical receives FDA 510(k) clearance for Knee+ NexSight
- The clearance covered a handheld augmented-reality guidance system tailored to total knee arthroplasty in ambulatory surgery centres.
- Knee+ NexSight overlays real-time navigation data in the surgeon’s field of view without requiring a bulky external robot or preoperative CT workflow.
- The platform was designed to work with primary knee implants while keeping the surgeon in direct control of bone-cut and implant-positioning decisions.
FDA clears MONARCH QUEST robotic-bronchoscopy upgrade
- MONARCH QUEST adds enhanced AI navigation and a verified interface for GE HealthCare’s OEC 3D mobile cone-beam CT imaging system.
- Its NVIDIA RTX accelerated computing stack increases real-time computational power by 260% for navigation algorithms.
- The update combines scope-in-sheath control and continuous vision with intraprocedural 3D imaging for targeting and tool-in-lesion confirmation.
Neuralink launches CONVOY feasibility study for robotic arm control
- Neuralink received approval and launched CONVOY, a feasibility study extending N1 Implant control to an assistive robotic arm.
- CONVOY is designed to evaluate whether people with paralysis can use the N1 Implant to control external robotic assistance.
- The study expands Neuralink's device-control work from computer interfaces toward physical assistive machines.
EndoQuest submits IDE application for PARADIGM clinical study
- The IDE submission covered a prospective clinical study for robotic colorectal procedures using EndoQuest's flexible platform.
- The event precedes FDA IDE grant and first-human-study execution.
Johnson & Johnson receives FDA IDE approval for OTTAVA robotic surgical system
- Johnson & Johnson MedTech received FDA investigational device exemption approval for OTTAVA.
- The approval allowed the company to begin a U.S. clinical trial of the robotic surgical system.
- The milestone preceded the first completed OTTAVA cases and later FDA submission.
Neuralink receives Health Canada approval for CAN-PRIME Study
- Neuralink received Health Canada approval to launch CAN-PRIME, its first international clinical trial.
- CAN-PRIME extends evaluation of the N1 Implant and R1 Robot system outside the United States.
- The trial studies safety and early effectiveness of Neuralink's implant and surgical robot system.
CMR Surgical receives U.S. FDA marketing authorization for Versius
- The authorization was granted through the FDA De Novo process for a multi-port soft-tissue robotic-assisted surgical device.
- The stated U.S. indication was cholecystectomy for adults 22 and older who are eligible for soft-tissue minimal-access surgery.
- The source describes the first-generation Versius system, so this event is not attached to the tracked Versius Plus variant.
Neuralink receives FDA Breakthrough Device Designation for Blindsight
- The visual prosthesis program is intended to restore visual perception for people with severe vision loss.
- The designation supports faster development and review but does not represent market approval.
PROCEPT BioRobotics receives FDA clearance for HYDROS robotic system
- PROCEPT BioRobotics received FDA 510(k) clearance for HYDROS, its next-generation robotic system for Aquablation therapy.
- HYDROS extends the company''s urology robotics platform with image-guided planning and treatment workflow updates.
- The regulatory milestone is a core commercial proof point for PROCEPT''s surgical robotics profile.
Globus Medical receives FDA clearance for ExcelsiusFlex orthopedic robot
- Globus Medical received FDA 510(k) clearance for the ExcelsiusFlex orthopedic robot.
- The clearance covers the ExcelsiusFlex robotic navigation platform with a total knee arthroplasty application.
- The approval extends Globus Medical's Excelsius robotics ecosystem from spine and cranial navigation into orthopedic reconstruction.
SSi Mantra surgical robotic system approved for telesurgeries in Indonesia
- • SS Innovations' SSi Mantra Surgical Robotic System received regulatory approval from the Indonesian Ministry of Health for clinical use i...
- • SS Innovations has commenced the regulatory approval process in the United States and the European Union.
- • The company anticipates FDA and CE Mark approvals in 2025.
FDA clears Intuitive da Vinci 5
- The system introduced optional Force Feedback instruments and a redesigned console.
- Intuitive described more than 150 system enhancements and expanded computing capacity.
- Initial U.S. availability was limited to selected customers before broader commercial introduction.
Zimmer Biomet receives FDA clearance for ROSA Shoulder System
- Zimmer Biomet received U.S. FDA clearance for the ROSA Shoulder System.
- The company described ROSA Shoulder as the first robotic assistant for shoulder replacement surgery.
- The clearance expands Zimmer Biomet's ROSA robotics portfolio from knee and hip into shoulder arthroplasty.
EndoQuest Flexible Robotic System enters FDA Safer Technologies Program
- The StEP acceptance applied to EndoQuest's flexible robotic system for endoluminal surgery, not to a general company milestone.
- FDA's Safer Technologies Program is intended to speed review interactions for devices expected to improve safety over available approaches.
- The event is regulatory pathway progress; it is not a clearance, approval or commercial deployment.
Neuralink opens recruitment for first-in-human PRIME Study
- Neuralink opened recruitment for its first-in-human PRIME Study at its first hospital site.
- The study targets people with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis.
- Neuralink described the study as evaluating the investigational N1 Implant and R1 Robot system.
Neuralink receives FDA approval to launch first-in-human PRIME Study
- Neuralink received FDA approval in May 2023 to launch its first-in-human PRIME Study.
- The study evaluates the safety and initial effectiveness of the N1 Implant and R1 surgical robot system for people with paralysis.
- The approval moved Neuralink from preclinical development into human clinical testing for its implantable brain-computer interface.
Noah Medical receives FDA clearance for Galaxy
- TiLT+ combines integrated tomosynthesis with augmented fluoroscopy for real-time target location.
- A disposable bronchoscope provides continuous visualization, including during biopsy.
Activ Surgical receives CE Mark for ActivSight Intelligent Light
- ActivSight attaches to laparoscopic systems and provides real-time surgical visualization overlays.
- Activ Surgical said the system had already seen clinical use in more than 200 patients and multiple in-human IRB studies.
- The event adds a concrete robotics milestone in human-assistive, manipulation or human-machine interaction workflows.
Medtronic expands Hugo approvals in Japan, Europe and Canada
- The approvals included Japan MHLW approval for urological and gynecological indications.
- The same announcement included CE Mark and Health Canada expansions for general surgery or laparoscopic indications.
FDA clears XACT ACE Xtend remote control unit
- The clearance permits robotic instrument insertion and steering from an interventional-radiology control room.
- ACE Xtend is designed to reduce staff radiation exposure and physical strain while improving workflow.
- The remote-control unit operates with the FDA-cleared XACT ACE system for CT-guided percutaneous procedures.
CMS grants AquaBeam transitional pass-through payment status
- The payment status applied through the 2020 outpatient prospective payment system.
- AquaBeam delivers image-guided robotic waterjet removal of prostate tissue for BPH.
- The reimbursement decision supported use of the exact system in outpatient care.
FDA clears ROSA ONE Brain application
- The application supported biopsy, SEEG, DBS and ventricular and transnasal endoscopy.
- Zimmer Biomet described ROSA ONE Brain as the next generation of its ROSA Brain platform.
- The clearance established the Brain application separately from the then-pending Spine application.