Johnson & Johnson Completes First Surgeries with OTTAVA Robotic System in Clinical Trial
• J&J has successfully performed the first gastric bypass surgeries using its OTTAVA robotic surgical system at Memorial Hermann-Texas Medical Center, marking a significant milestone in the system's development.
• The OTTAVA system features a unique design with four arms built into the operating table, targeting multiple procedures in general surgery within the upper abdomen, including gastric bypass, gastric sleeve, and hiatal hernia repair.
• Following completion of the clinical trial, J&J plans to submit the OTTAVA system for De Novo authorization to the FDA, aiming to compete with market leader Intuitive Surgical in the growing robotic surgery market.
FDA Clears First Stapler for Single-Port Robotic Surgery with da Vinci SP System
• Intuitive Surgical received FDA 510(k) clearance for the SureForm 45 stapler, marking the first stapler designed specifically for single-port robotic surgery in the United States.
• The fully-wristed stapler features SmartFire technology that continuously monitors tissue compression before and during firing, helping surgeons enhance staple line integrity and reduce tissue damage risk.
• The device is cleared for use with the da Vinci SP surgical system in urologic, thoracic, and colorectal procedures, allowing surgeons greater control without relying on assistants.
FDA Clears J&J's AI-Enhanced Monarch Robot for Improved Lung Cancer Diagnosis
• Johnson & Johnson's Monarch Quest software update received FDA 510(k) clearance, boosting computational power by 260% to improve accuracy in reaching suspicious lung nodules.
• The enhanced robotic platform integrates Nvidia's AI technology and GE Healthcare's OEC 3D mobile imaging system to navigate complex patient airways for more precise early-stage lung cancer diagnosis.
• This advancement addresses a critical need in lung cancer detection, as nearly half of early-stage lesions occur in peripheral lung areas that are difficult to access with traditional bronchoscopy methods.
Medtronic Plans FDA Submission for Hugo Surgical Robot, Eyes US Launch in FY2026
• Medtronic is preparing to submit its Hugo surgical robot system for FDA authorization by March 2024, targeting initial approval for urology indications.
• The company reports significant international growth for Hugo, with procedure volumes more than doubling year-over-year in existing markets.
• Medtronic's surgical robotics expansion comes amid evolving competition in the soft tissue robotics market, where Intuitive Surgical maintains leadership with its da Vinci system.
Biopharma Industry Faces Pivotal Year: J.P. Morgan Conference Signals Key 2025 Challenges
• The 2024 J.P. Morgan Healthcare Conference kicked off with significant M&A activity, including Johnson & Johnson's $15 billion acquisition of Intra-Cellular Therapies.
• Despite notable deals from GSK and Eli Lilly with biotech companies, industry sentiment remains cautious amid regulatory uncertainty and questions about investment returns.
• Key challenges facing the sector include Trump administration's healthcare policies, investor confidence in biotech, success of immunology and obesity drug investments, and growing Chinese competition.
J&J MedTech's Ottava Robotic Surgical System Enters Clinical Trials
• Johnson & Johnson's MedTech division has received IDE approval for its Ottava robotic surgical system, allowing clinical trials in the U.S.
• Ottava features four low-profile robotic arms integrated into the operating table, offering enhanced surgical flexibility and space conservation.
• The system's 'twin motion' feature synchronizes table and robotic arm movements, improving access to surgical quadrants and precision.
• Ottava aims to compete in the growing surgical robotics market, potentially enhancing surgical outcomes and clinical decision-making.
J&J's Ottava Surgical Robot Cleared for U.S. Clinical Trials
• Johnson & Johnson received FDA IDE approval to begin U.S. clinical trials for its Ottava surgical robot, marking a significant step in its development.
• The Ottava system incorporates Ethicon surgical instruments and a digital system, Polyphonic, to enhance surgical technology and clinical decision-making.
• Designed to address unmet needs in robotic surgery, Ottava aims to compete with Intuitive Surgical's da Vinci system in the growing market.
• Ottava features a compact design with four arms integrated into the operating table, supporting various surgical approaches, including robotic, laparoscopic, and open surgery.
Robotic Nipple-Sparing Mastectomy Shows Promise in Early Breast Cancer Treatment
• Robotic nipple-sparing mastectomy (NSM) is emerging as a potential alternative to open NSM, offering improved visualization and potentially better sensory outcomes.
• A prospective, multicenter randomized controlled trial (NCT05720039) is underway to evaluate the safety and oncologic outcomes of robotic NSM compared to open NSM for early-stage breast cancer.
• The robotic NSM procedure, performed using the da Vinci Single Port Surgical System, involves a hidden 3-cm incision and CO2 insufflation, potentially reducing nerve damage and improving nipple sensation.
• Early case reports demonstrate successful robotic NSM with immediate prepectoral implant reconstruction, showing promising results in terms of postoperative recovery and clinical response.
FDA Approves Pivotal Trial of Aquablation Therapy vs. Prostatectomy for Localized Prostate Cancer
• The FDA has approved an IDE trial comparing Aquablation therapy to radical prostatectomy for localized prostate cancer.
• The WATER IV PCa trial will enroll 280 patients with Grade Group 1-3 localized prostate cancer across 50 sites.
• The study's primary endpoint is morbidity at 6 months, with long-term follow-up on treatment-related harm and oncologic events.
• Aquablation, already approved for BPH, aims to improve safety and quality of life outcomes compared to prostatectomy.
SS Innovations Advances SSi Mantra Surgical Robot Toward FDA Approval
• SS Innovations is pursuing FDA approval for its SSi Mantra Surgical Robotic System, aiming to provide affordable robotic surgery options.
• The company completed a pre-submission meeting with the FDA, receiving feedback on regulatory strategy and clinical data requirements.
• SS Innovations plans to submit an IDE application in Q1 2025 and anticipates potential pre-market approvals by the end of 2025.
• Clinical trials will be conducted for various indications, leveraging existing data from India and planned trials in the United States.
© Copyright 2025. All Rights Reserved by MedPath