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This audio is auto-generated. Please let us know if you have feedback<\/a>.<\/p>\n Dive Brief:<\/p>\n Johnson & Johnson said Wednesday it has submitted its Ottava soft tissue robotic surgery system<\/a> to the Food and Drug Administration for de novo classification in general surgery. The company has applied for marketing authorization in multiple procedures within the upper abdomen. Dive Insight:<\/p>\n The FDA submission for Ottava follows Medtronic\u2019s U.S. clearance in December<\/a> for its Hugo robotic surgery system in urologic procedures. The two leaders in surgical instrument manufacturing will challenge Intuitive Surgical\u2019s decades-long dominance in the robot-assisted soft tissue surgery market.<\/p>\n \u201cWe have taken learnings from Johnson & Johnson\u2019s 140 years in surgery, our decades of leadership in minimally invasive surgery, and the experiences robotic surgeons and hospitals have had over the past 20 years to design a soft tissue robotic system built for the future of surgery,\u201d Hani Abouhalka, company group chair for surgery at J&J MedTech, said in a statement.<\/p>\n Smaller companies, too, such as CMR Surgical<\/a> and Stereotaxis<\/a>, have recently gained FDA clearance for new robotic platforms and are working to launch those systems in the U.S. In December, SS Innovations International filed an FDA submission<\/a> seeking authorization for its SSi Mantra robot in multiple soft tissue procedure types.<\/p>\n J&J said its de novo classification request is targeting an indication covering multiple procedures in general surgery within the upper abdomen, such as gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.<\/p>\n Ottava\u2019s differentiated architecture, surgical instrumentation and technological capabilities are designed to address unmet needs for clinical teams across a range of procedures, including the most complex surgeries that require a multi-quadrant approach, the company said.<\/p>\n Stifel analyst Rick Wise noted J&J\u2019s approach to Ottava, with integrated table motion, is unique within the surgical robotics space. The timing of the submission announcement, just days into the first-half 2026 window the company targeted, shows J&J\u2019s confidence in Ottava\u2019s development, Wise wrote to clients Wednesday.\u00a0<\/p>\n \u201cFor Intuitive Surgical, this announcement highlights the well-known, well-understood fact that the US robotic market competitive environment is going to become more-crowded,\u201d said Wise. \u201cThat said, Intuitive’s broad and deep ecosystem, multiple robots, including the highly-differentiated DV5, indicates that the company is well-positioned to address competitive challenges.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"Listen to the article 3 min This audio is auto-generated. Please let us know if you have feedback.…\n","protected":false},"author":2,"featured_media":396290,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[49,48,84,392],"class_list":{"0":"post-396289","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-healthcare","8":"tag-ca","9":"tag-canada","10":"tag-health","11":"tag-healthcare"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/396289","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=396289"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/396289\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/396290"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=396289"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=396289"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=396289"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nThe application is supported by data from the company\u2019s investigational device exemption study in Roux-en-Y gastric bypass, a type of weight-loss surgery that creates a small pouch from the stomach to reroute food to the small intestine.
\nJ&J said it also received IDE approval in late 2025 to begin a U.S. clinical trial to study Ottava in inguinal hernia procedures, one of the most common surgeries in the U.S.<\/p>\n