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FDA granted De Novo authorization for OTTAVA robotic surgery system, enabling commercial rollout.
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Medtronic Wins FDA Clearance for LigaSure on Hugo Robotic Surgery System
Medtronic received FDA clearance for its LigaSure vessel-sealing device on the Hugo robotic surgery system in the United States. The authorization allows LigaSure to be used on the Hugo platform for soft-tissue procedures in U.S. hospitals and surgical centers, integrating a widely used vessel-sealing tool with Medtronic's robotic-assisted surgery platform for general surgery use. The clearance ties a familiar energy device into a newer robotic platform, helping Hugo look less like an isolated project and more like part of a multi-platform ecosystem as Medtronic competes with peers such as Intuitive Surgical and Johnson & Johnson. Medtronic's US$118.7 billion scale in medical equipment gives it a broad installed base where new tools on the Hugo robotic system can plug into existing surgical workflows. The unresolved piece is scale, as analysts have already flagged execution risks in major product ramp-ups and the approval does not yet answer how quickly hospitals will adopt Hugo for a wider mix of soft-tissue procedures.
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Intuitive Surgical Wins CE Mark for da Vinci SP in Transvaginal Gynecologic Procedures
Intuitive Surgical announced that its da Vinci SP surgical system received CE mark approval in Europe for transvaginal gynecologic procedures, the platform's first such indication globally. The authorization expands the SP system's approved applications in women's health and extends its natural orifice surgery portfolio beyond transoral and transanal procedures, supporting the company's strategy of growing the platform through new indications rather than relying solely on new system placements. The approval could help increase utilization of the existing da Vinci SP installed base across Europe, a key driver of recurring revenue through instruments, accessories and service revenue. During its second-quarter 2026 earnings call, management highlighted that SP procedures surged 61% year over year, driven by expanded indications, new instrumentation and broader adoption, while the company placed 38 SP systems in the quarter, up from 23 a year ago, taking the global installed base to 445 systems. Intuitive Surgical also noted that more than 1,000 peer-reviewed publications support the safety and efficacy of the da Vinci SP platform.
Johnson & Johnson Targets Double-Digit Growth by End of Decade
Johnson & Johnson said it remains on track to grow through biosimilar competition for STELARA and expects its medicines, medical devices and pipeline to support accelerating growth through the end of the decade. Speaking at a Morgan Stanley event, Chief Executive Officer and Chairman Joaquin Duato said the company's current guidance calls for 6.5% adjusted operational sales growth and 7.3% adjusted earnings-per-share growth in 2026, with total revenue expected to exceed $100 billion for the first time. Duato said 2027 should be a better year than 2026 and that the company has line of sight to double-digit growth by the end of the decade, with more detail to come at an enterprise business review in early December. John Reed, executive vice president of Innovative Medicine and R&D, said Johnson & Johnson has 12 molecules that have achieved proof of concept and are in Phase III development, and that beyond DARZALEX it has 10 marketed medicines still early in their product life cycles. Capital allocation priorities center on launches such as ICOTYDE, INLEXZO, RYBREVANT, IMAAVY and the OTTAVA robotic surgical system, plus pipeline funding and earlier-stage business development, including the recent acquisitions of Halda Therapeutics and Firefly Bio and a collaboration with an option to acquire Sail. Duato said the company can reach double-digit growth this decade without acquisitions but views M&A as a way to reinforce growth into the following decade.