Medtronic Announces Expanded CE Mark Indication for Affera™ Mapping and Ablation System and Sphere-9™ Catheter

Medtronic has announced an expanded CE Mark indication for the Affera™ Mapping and Ablation System with Sphere-9™ Catheter to treat ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVCs). The Sphere-9 catheter is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter CE marked for ventricular ablation.

“This milestone is a major step forward as we continue to expand the footprint of the Affera technology to more physicians and patients,” said Rebecca Seidel, president of the Electrophysiology Therapies business at Medtronic. “Indication expansion to include ventricular arrhythmias unlocks another fast-growing market opportunity to keep building on our momentum, powered by the versatility, safety and efficiency of the Sphere-9 catheter.”

Additionally, in recognition of the critical unmet need for ventricular arrhythmia treatments, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Sphere-9 catheter for the treatment of ventricular arrhythmias, which provides an expedited regulatory pathway for the technology in this patient population. The Sphere VT pivotal trial to evaluate Sphere-9 for the treatment of VT and support future approval in the US is now enrolling patients.

The Affera Mapping and Ablation System with Sphere-9 Catheter is an all-in-one, dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping catheter for use in cardiac ablation procedures.

“Physicians have long needed better tools for ventricular arrhythmias, and we’re proud to deliver a technology that addresses this unmet need and moves the needle on patient care,” said Khaldoun Tarakji, M.D., MPH, vice president, chief medical officer, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “The unique features of Sphere-9, including a single catheter to map and ablate using radiofrequency or pulsed field energy and a large footprint, make it an excellent tool for a variety of arrhythmias, including those that may be challenging to treat.”

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

  1. Sciria,C. et al. Trends and Outcomes of Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic and Nonischemic Cardiomyopathy. Circ: Arr. and Elec. 2022; vol.15, no. 4.
  2. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias.
  3. Cheung, J, et al. Outcomes, Costs, and 30-Day Readmissions After Catheter Ablation of Myocardial Infarct–Associated Ventricular Tachycardia in the Real World: Nationwide Readmissions Database 2010 to 2015. Circ: Arr. and Elec. 2018; vol. 11, issue 11.
  4. American Heart Association, “Premature Contractions: PACs and PVCs.” https://www.heart.org/en/health-topics/arrhythmia/about-arrhythmia/premature-contractions-pacs-and-pvcs

Source: Medtronic plc

meerecompany Announces Second Export of ‘Revo-i’ to Mongolia

  • Supply to Mongolia’s largest tertiary general hospital and expanding clinical application to the field of organ transplantation.
  • Consecutive supply to key national hospitals in cancer and organ transplantation fields, strengthens market presence in Mongolia.

meerecompany has announced that it has completed its second export of its surgical robot, Revo-i, to Mongolia. The recipient of this supply is The First Central Hospital of Mongolia, located in the Sukhbaatar District of Ulaanbaatar, Mongolia.

The First Central Hospital of Mongolia is a tertiary general hospital with a capacity of 568 beds and stands as one of the largest national hospitals in Mongolia. It is a representative medical institution that performs various high-difficulty surgeries, with a central focus on the field of organ transplantation

This supply marks the second export case of Revo-i, following its introduction at the National Cancer Center of Mongolia. While the National Cancer Center of Mongolia serves as a base hospital specializing in cancer treatment, The First Central Hospital is a leading medical institution in the field of organ transplantation. By supplying Revo-i to key medical institutions in different specialized medical fields, meerecompany has successfully built clinical references that encompass both cancer surgery and organ transplantation.

Viewing Mongolia as a crucial overseas market, meerecompany has been continuously expanding its local cooperative network, encompassing the government, medical institutions, and academic societies.

In March 2025, the company signed a Memorandum of Understanding (MOU) with the Health Development Center under the Mongolian Ministry of Health to cooperate on improving the Mongolian healthcare system. Following this, in May of this year, it signed an MOU with the Mongolian Federation of Obstetrics and Gynecology, laying the groundwork for robotic surgery education and academic exchange.

In addition, the company participated in the International Congress of Organ Transplant (ICOT 2026) held in Mongolia from June 5 to 6. Through this event, meerecompany introduced Revo-i and expanded exchanges with local medical professionals, actively promoting the applicability of robotic surgery in the field of organ transplantation. Ho Kun Lee, Executive Vice President and Head of the Surgical Robot Division at meerecompany stated, “This supply is highly significant in that we have consecutively supplied Revo-i to Mongolia’s key national hospitals representing the fields of cancer and organ transplantation.” He added, “We expect this to serve as an opportunity to once again prove Revo-i’s technological prowess and clinical competitiveness while further strengthening our presence in the Mongolian market.”

He further noted, “The clinical experience accumulated in major national hospitals will become an important reference not only for expanding the local market in the future but also for entering neighboring markets.” He concluded, “We will continue to contribute to the development of local medical technology based on close cooperation with the Mongolian government and major medical institutions, while consistently expanding our global business.”

Source: meerecompany

Rob Surgical Secures EU CE Mark for ROB® Surgical Robot

Rob Surgical Systems has received the European Union CE mark for the use of its ROB® surgical robot and associated instruments in urological surgical procedures. The certification represents a major milestone for the company, confirming that the ROB® platform meets the European Union’s regulatory requirements for safety, quality and clinical performance.

Following this initial certification in urology, Rob Surgical is advancing the expansion of the ROB® platform into additional surgical specialties, including general surgery and gynecology. The company is now entering a new phase focused on the deployment and integration of the ROB® system across European healthcare systems, while progressively broadening its clinical applications.

“The CE mark is one of the defining milestones in Rob Surgical’s history,” said Mario Ferradosa, CEO of Rob Surgical Systems. “This achievement reflects more than 15 years of scientific research, technological innovation unique to Spain, clinical development and regulatory discipline, made possible by an exceptional team. It also marks the beginning of a new chapter for the company, as we continue to advance our technology and expand its capabilities across multiple surgical specialties, including general surgery and gynecology.”

ROB® is a robotic surgery platform designed for minimally invasive procedures in specialties including urology, general surgery and gynecology. The system integrates four robotic arms on a single cart and features an open architecture designed to facilitate integration into existing operating rooms without requiring hospitals to replace current equipment or significantly modify established surgical workflows.

The European CE mark for urology concludes a clinical development process that began in April 2023, when the first procedures using the ROB® system were performed on patients at Hospital Clínic de Barcelona.

The milestone follows the opening of Rob Surgical’s first manufacturing facility in El Prat de Llobregat (Catalonia, Spain) in early 2026. The new plant enables the company to manufacture the ROB® system and progressively scale production capacity ahead of its commercial rollout.

Source: Rob Surgical

Medicaroid Announces CE Marking Under the MDR for the hinotori™

Medicaroid Corporation has announced that the CE marking under the Medical Device Regulation (MDR(2017/745)) has been obtained for the hinotori™ Surgical Robot System (hereinafter referred to as “the hinotori™”).

The hinotori™ was originally approved for manufacturing and marketing in Japan in 2020 and subsequently launched domestically. It thereafter received regulatory approvals in Singapore in 2023 and Malaysia in 2024, and has been introduced at medical institutions acrossthese regions. To further support its expansion in the Asia-Pacific region, it received regulatory approval in Vietnam in 2026.

In parallel with advancing the business in Japan and the Asia-Pacific region, Medicaroid has been preparing for expansion into Europe, the Middle East, and Africa (EMEA). To support this initiative, Medicaroid Europe GmbH was established in Germany in 2020 as a base of operations. With the acquisition of CE marking, Medicaroid is now able to market the hinotori™ in EU member states as well as certain non-EU countries. Entry into the European market represents a significant milestone for Medicaroid in continuing to contribute to global healthcare through medical robots. Medicaroid remains dedicated to supporting a thriving society where patients, their families, and healthcare professionals can live healthier, more peaceful lives.

Source: Medicaroid Corporation

Revo-i Recognised as an Innovative Product by the Ministry of Trade, Industry and Resources

  • First designation among endoscopic surgical robots and simultaneous recognition of the innovativeness and public value of Korean endoscopic surgical robots
  • Laying the groundwork for expanding its introduction to national and public medical institutions nationwide, based on public procurement benefits such as direct contracting

meerecompany has announced that its surgical robot, Revo-i, has become the first endoscopic surgical robot to be newly designated as an Innovative Product for the first half of 2026 by the Ministry of Trade, Industry and Resources.

The Innovative Product system is designed to support the entry of excellent products developed by small and medium-sized enterprises (SMEs) and middle-market companies into the public market, and to revitalize public procurement. Once designated as an Innovative Product, the product becomes eligible for direct contracts for up to six years in government contracts, and can receive various public procurement support benefits, including pilot purchase program.

Revo-i, the product designated this time, is the first endoscopic surgical robot developed by meerecompany utilizing Korean technology. Revo-i is characterized by its ability to enhance surgical convenience for surgeons, utilizing high-resolution 3D imaging, a wide field of view, and precise movements through articulated instruments. It is currently in use at major Korean hospitals such as Severance Hospital and the Korea Cancer Center Hospital, and has successfully entered overseas markets including Mongolia, Uzbekistan, Russia, Paraguay, Tunisia, and Morocco. Furthermore, it has been widely applied across a spectrum of procedures—from low- to high-difficulty surgeries—in various medical departments, including urology, general surgery, obstetrics and gynecology, and thoracic surgery, consistently accumulating clinical cases.

Innovative Products are designated through a comprehensive evaluation of a product’s public value and innovativeness. In terms of public value, Revo-i received high praise for lowering the financial burden of introducing expensive robotic surgery through localization, contributing to the improvement of medical service quality. It was also recognized for its potential to help bridge the healthcare gap in public medical settings and strengthen the public healthcare system through its reasonable introduction cost. In terms of innovativeness, along with the novelty of being the first Korean-developed endoscopic surgical robot, its proven technological prowess was recognized through Ministry of Food and Drug Safety (MFDS) approval, designation as an innovative medical device, the securing of numerous patents, and its selection as a Next-Generation World-Class Product.

Safety (MFDS) approval, designation as an innovative medical device, the securing of numerous patents, and its selection as a Next-Generation World-Class Product.

With this Innovative Product designation, Revo-i’s entry into the Korean public procurement market is expected to expand even further. Public medical institutions, including national and public hospitals, will be able to introduce Revo-i in a more flexible manner, which is expected to increase accessibility to advanced robotic surgery and contribute to resolving regional healthcare disparities.

Ho Kun Lee, Executive Vice President and Head of the Surgical Robot Division at meerecompany, stated, “In order to resolve the healthcare gap between regions, it is of utmost importance to create an environment where public medical institutions, which serve as regional hubs, can introduce advanced robotic surgical equipment at a reasonable cost.” He added, “Using this Innovative Product designation as momentum, we will continually strive to ensure that Revo-i is more widely distributed to public medical institutions nationwide, thereby contributing to enhancing public healthcare access and the quality of medical services.”

Source: meerecompany

Interventional Systems Partners with IRCAD

Interventional Systems (INS) announces agreement with IRCAD France, integrating the Micromate™ robotic platform into the institute’s minimally invasive surgery training curriculum.

The adoption of new technology starts with training and hands-on exposure. More than conferences or virtual learning environments, practical experience in a clinical simulation environment is what moves a field forward – and no institutions are better placed to deliver it than IRCAD France in Strasbourg.

Widely regarded as the world’s foremost center for minimally invasive surgery education and research, IRCAD has made surgical robotics a cornerstone of its training mission, consistently partnering with innovators to give surgeons direct access to emerging technologies. Unlike larger robotic platforms surgeons may already be familiar with, Micromate™ introduces a miniature alternative for robotic percutaneous surgery.

CE-marked and FDA-cleared, Micromate™ is a miniature robotic platform for any needle-based procedure using 2D or 3D imaging. It supports accurate instrument positioning, procedural consistency, and reduced radiation exposure for OR staff and patients.

Now installed at IRCAD France, Micromate™ will be incorporated into a growing range of courses. Two are already confirmed for 2026:

  • Intraoperative Ultrasound Navigation for Liver Resection and Thermoablation — July 9–11, 2026 [More info here]
  • Ablation and Percutaneous Surgery — November 30–December 2, 2026 [More info here]

Source: Interventional Systems (INS)

Distalmotion Announces US FDA 510(k) Clearance for Additional Gynecology Indications

Distalmotion has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection for the DEXTER® Robotic Surgery System.

This is the second US clearance for DEXTER in gynecology and the fourth overall, including general surgery indications for inguinal hernia repair and cholecystectomy. This latest clearance adds to the previous gynecology clearance, which included hysterectomy and salpingo-oophorectomy.

In ambulatory surgery centers (ASCs), where efficiency is critical, these additional procedures enable administrators to expand their gynecologic surgery service line while meeting both the demand for robotics in women’s health and efficiency metrics to maximize system utilization and increase throughput.  With DEXTER, surgeons can now treat their patients robotically across diverse gynecologic conditions in a more convenient, lower cost site of care. 

“Securing FDA clearance for these additional GYN indications is another important milestone for the DEXTER program,” said Greg Roche, CEO of Distalmotion. “By enabling a comprehensive GYN service line, we are empowering care teams to maximize their workflows and deliver the combined benefits of robotics and same-day care to a broader patient population.”

In parallel with this commercial expansion, Distalmotion continues to advance its clinical pipeline with its US Investigational Device Exemption (IDE) study for DEXTER in myomectomy. 

With more than 4,000 patients treated with DEXTER, Distalmotion continues to advance its mission to expand access to robotic surgery across high-volume outpatient procedures.

Source: Distalmotion

Medicaroid Receives Regulatory Approval in Vietnam for hinotori™

Medicaroid Corporation has announced that regulatory approval has been received from the Vietnam Infrastructure and Medical device Administration, Ministry of Health Vietnam, for the hinotori™ Surgical Robot System.

hinotori™ was developed as a robotic assisted surgery system to reproduce surgeon’s sensitive movement, which is essential for surgeries. What made this possible is Kawasaki Heavy Industry‘s robot technology cultivated for over 50 years and Sysmex Corporation’s network and knowledge in the healthcare field. Medicaroid will pursue the development of new features and service to realize the non-invasive patient-friendly surgery.

hinotori™ is composed of the three units; Surgeon Cockpit, Operation Unit and Vision Unit.

Source: Medicaroid

Moon Surgical Announces Maestro® Software Version 2.7

Moon Surgical has announced Maestro® Software Version 2.7, a major platform update that expands Maestro from a single AI capability to a multi-model intelligent platform operating across the surgical workflow.

Version 2.7 introduces three coordinated AI-driven capabilities enabling targeted automation across setup, surgery, and post procedure administration, reducing workflow friction and operational burden for surgical teams:

  • Automated Setup (Physical AI): dynamic optimization of platform positioning and workspace configuration based on surgeon preferences, OR layout, surgical technique and patient-specific anatomy;
  • ScoPilot® (Physical AI, enhanced): improved intraoperative assistance, leveraging expanded datasets from newly observed instruments and clinical configurations, enabled by Moon Surgical’s FDA-cleared Predetermined Change Control Plan (PCCP);
  • Automated Operative Reports and Coding, via third-party AI solutions: the first external AI-powered application deployed on the Maestro platform, designed to turn surgical videos into complete post-operative documentation and optimized procedural coding, before the surgeon leaves the OR.

Together, these capabilities enable targeted automation across setup, surgery, and post procedure administration, streamlining documentation, coding, and operational workflows while reducing burden on surgical teams.

Additional enhancements include:

  • Mobile Standby Mode enables rapid repositioning and room-to-room transfer while maintaining platform readiness
  • Boot time reduction by 40%, enabling faster platform availability and improving operating room efficiency

Version 2.7 also marks the first integration of a third party-developed capability, reflecting Maestro’s open ecosystem and on-premise edge computing infrastructure, as a platform for deploying AI solutions in the operating room. With Version 2.7, the Maestro Platform powers a continuum of perioperative intelligence that enhances surgical care both inside and outside the operating room, combining real-time intraoperative assistance with automated and secure post-operative insights and workflow execution.

These innovations are powered by Moon Surgical’s growing dataset of over 3,000 procedures, enabling continuous training and validation of AI models.

“Version 2.7 reflects our focus on building a platform designed for the realities of today’s operating environment, particularly in ambulatory settings, where efficiency, flexibility, and consistency are critical,” said Anne Osdoit, CEO of Moon Surgical and Partner at Sofinnova Partners.. “By improving capabilities like ScoPilot and introducing targeted automation across setup and documentation, we are reducing friction for surgical teams while enabling more predictable workflows and improved patient throughput. This is core to our vision of making high-quality surgery more scalable and equitable.”

Maestro Software Version 2.7 is being deployed across the installed base, subject to regulatory requirements.

Source: Moon Surgical