2026Year1Month7Recently, Johnson & Johnson (NYSE:JNJ) announced that it has submitted to the U.S. Food and Drug Administration (FDA) Submit itsOttavaNew Surgical Classification Application for Soft Tissue Robotic Surgery Systems, Targeting Coverage of Upper Abdominal General Surgeries Including Gastric Bypass, Sleeve Gastrectomy, Small Intestine Resection, and Hiatal Hernia Repair.

This application is distant from the competitor Medtronic (NYSE:MDT）HugoThe robotic system gained access to the U.S. market just one month ago,Marks the official entry into the white-hot stage of competition in the field of soft tissue robotic surgery.

Johnson & Johnson emphasized in the statement，OttavaThe system integrates the company140Years of surgical practice, decades of leadership in minimally invasive surgery, and the past20Years of in-depth collaboration experience with surgeons and hospitals.According to Johnson & JohnsonMedTechChairman of the Surgical GroupHani AbouhalkaIt was revealed that the system adopts a differentiated architecture design, supporting multi-quadrant complex surgical operations. Its integrated desktop motion solution is unique in the field of surgical robotics. This application has been granted.Roux-en-YData Support for Gastric Bypass Surgical Instrument Exemption Study — This bariatric surgery achieves weight control by creating a small gastric pouch and rerouting food to the small intestine, demonstrating significant clinical demand.

Johnson & Johnson disclosed,2025By the end of the year, it has been obtained.FDAInvestigational Device Exemption (IDE) Approval, Official LaunchOttavaClinical trials of inguinal hernia surgery in the United States. As one of the most common surgeries in the U.S., the clinical validation of inguinal hernia repair will directly assess the system's applicability in high-frequency general surgical procedures. The company further clarified that the new classification application focuses on upper abdominal surgery indications, aiming to meet the unmet needs of clinical teams in complex multi-quadrant surgeries.

This application coincides with MedtronicHugoSystem2025Year12One month after receiving U.S. approval, the two major device giants formally confront Intuitive Surgical (NASDAQ:ISRG）—— The latter has dominated the robot-assisted soft tissue surgery market for two decades with the da Vinci Surgical System. Johnson & Johnson's choice to submit the application at this time aligns with its2026Display of the first half of the year's development window planningOttavaConfidence in the commercialization process. Despite intensified market competition, Intuitive Surgical relies on its deep ecosystem (including multiple differentiated robots such asDV5Platform) still possesses a solid competitive barrier.

Notably, small innovative enterprises are also accelerating their layout.CMR Surgical、StereotaxisRecently obtained successivelyFDAApproval of New Robotic Platform,SS Innovations InternationalMore at2025Year12Monthly SubmissionSSi MantraRobotics Multi-Procedure Authorization Application. Analysts point out that with the acceleration of technological iteration and the clarification of regulatory pathways, the robotic surgery market will evolve from "one dominant player" to "multi-polar competition," with clinical needs, cost-effectiveness, and physician training systems becoming the key to success.

Through“14th Five-Year Plan”Planning, the National Medical Products Administration's special review process for innovative medical devices, and other policies clearly define surgical robots as“Healthy China”The intersection point with the high-end equipment manufacturing strategy.2025In the year, the "Directory for the Administration of Permits for the Allocation of Large Medical Equipment" was adjusted to simplify the approval process. The allocation quota for endoscopic robots was significantly relaxed, and robot-assisted surgeries were included in the reimbursement scope by medical insurance in multiple regions, promoting clinical adoption.

Multiple domestically-produced surgical robots have emerged.Leading enterprises:

• Minimally Invasive Robot: Tumai Endoscopic System Receives China's First Full-Department Remote Surgery Approval, Completes World's First Case100Example5GRemote Surgery, Gains Approval in India, USFDAApproved by multiple countries.

  
  

• MicroPort MedBot: Multi-Port Endoscopic Robot Receives Full Department Application Registration Certificate, Surgical Volume Surges Year-on-Year150%, covering fields such as urology, gynecology, and general surgery.

  
  

• Conorth:SentireStryker's Endoscopic Robot Successfully Completes Multiple Clinical Trials in Humans (e.g., Radical Prostatectomy)100%, achieving full self-research and development of the entire machine (mechanical architecture, power module,AICore technologies such as algorithms are independently controllable.

  
  

Market Size and Growth:2024The scale of China's surgical robot market in ... is about95.9100 million yuan,2025Year or Reach110.3100 million yuan, with an average annual compound growth rate34.5%. Endoscopic robots dominate (sales exceed50%), orthopedic and neurosurgical robots followed closely behind. The global market share of Chinese-produced robots increased from5%Leap to28%, the cost has been reduced to one-third of imported products, and exported to markets in Southeast Asia, the Middle East, and more.

Johnson & Johnson's recent application not only marks its strategic deepening into the robotic surgery field but also signals that the global medical device industry is ushering in a new wave of technological innovation and market restructuring. As more companies join the competition,Instrument Family willClosely monitor the clinical progress, regulatory approvals, and commercialization pace of each company.