The basics:

• FDA grants de novo authorization for J&J’s Ottava robotic surgery system
• Table-integrated system authorized for 10 upper abdominal procedures
• J&J says Ottava uses 30%–50% less space than traditional systems
• Company plans limited US commercial launch with select customers

Johnson & Johnson announced July 22 that the U.S. Food and Drug Administration granted marketing authorization for its Ottava Robotic Surgical System. 

Described as the world’s first table-integrated soft tissue robotic system, the technology received de novo authorization for multiple procedures in upper abdomen general surgery. That includes: 

• Roux-en-Y gastric bypass 
• Gastrectomy 
• Cholecystectomy 
• Splenectomy 
• Gastric sleeve 
• Small bowel resection 
• Appendectomy 
• Lysis of adhesions 
• Fundoplication 
• Hiatal hernia repair 

The New Brunswick health giant’s MedTech sector developed the system. The company said Ottava’s compact design creates more room for surgical teams to move in the operating room. According to J&J, the system “integrates robotic arms into the OR table and occupies 30–50% less space than traditional boom- and cart-mounted systems.” 

Factoring in workflow

“Surgical robotics will play an increasingly important role in surgical care, but it’s clear that what defined the last 25 years of surgery will not define the next 25,” Hani Abouhalka, J&J Medtech‘s company group chair, Surgery, said in a statement.  

“By opening up the way we think about architecture, data, and the very workflows of surgery itself, we have designed OTTAVA to deliver clinical and economic benefits and support surgeons and hospitals as the future of surgery unfolds,” Abouhalka added. 

Additional features of the Ottava system include: 

• Software controls that coordinate the four table-integrated arms 
• Automated procedural poses to simplify setup and breakdown 
• Synchronized table and arm motion that allows for patient repositioning and access with limited adjustments 
• Next-generation robotic surgical instruments 

Learn more about Johnson & Johnson’s Ottava Robotic Surgical System (video provided by J&J):

Connecting skill with data

Ottava is also connected to J&J’s Polyphonic digital solution, which provides the medical team with media and data throughout the surgery. 

Dr. Peter Schulam, J&J Med Tech’s chief scientific officer, said the system is designed to connect a surgeon’s skill and judgment with data and insights. 

“We are pioneering a new category of surgical robotics with OTTAVA,” added Tim Schmid, J&J Med Tech’s executive vice president and worldwide chairman. He called the system “the start of the next era in surgery.” 

The company will commercially launch the Ottava system with select domestic customers. J&J said a U.S. clinical trial for the system in inguinal hernia procedures is ongoing.

Company kudos

Johnson & Johnson was recently named to Time’s America’s Best Companies of 2026, landing at No. 24, as well as U.S. News & World Report’s unranked 2026-2027 U.S. News Best Companies to Work For list. An analysis by online small business lender OnDeck also found that J&J is “New Jersey’s most valuable homegrown brand,” based on data from Brand Finance and Interbrand.

In recent years, J&J has strengthened its MedTech division with moves such as:

• Spinning off its orthopedics unit to focus on faster-growing areas
• Acquiring V-Wave Ltd., which develops treatment options for patients with heart failure, for $1.7 billion
• Buying Shockwave Medical Inc., which develops and commercializes products to treat cardiovascular disease, for $13.1 billion