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General surgery

What's next in general surgery — October 11, 2026

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This edition covers what is coming in general surgery between mid-October 2026 and April 2027. We include only milestones with a verifiable date in an official or primary source; this time a single item meets that standard, and we would rather not pad the list. Off the list, we are tracking the 510(k) filings Medtronic submitted to the FDA on June 3, 2026 to expand the Hugo robotic system to general surgery (including hernia repair) and gynecology; we do not count them as an item because neither the FDA nor the company has given a decision date.
Source: https://news.medtronic.com/2026-06-03-Medtronic-submits-510-k-filings-to-expand-Hugo-TM-robotic-assisted-surgery-system-into-general-and-gynecologic-specialties-in-the-United-States

1. FDA decision on CagriSema for weight management

[Pending regulatory decision] [United States] [Estimated date: late 2026, per Novo Nordisk]
What it is: A once-weekly subcutaneous fixed-dose combination of cagrilintide (amylin analogue) 2.4 mg and semaglutide 2.4 mg. Novo Nordisk announced the submission of its New Drug Application to the FDA on December 18, 2025, based on the phase 3 REDEFINE 1 and REDEFINE 2 trials; in its February 23, 2026 announcement the company said it anticipates an FDA decision "by late 2026". No public PDUFA date exists.
What problem it solves: It widens the drug options for obesity, which may change who reaches the metabolic and bariatric surgery clinic and with how much weight already lost; and because both components slow gastric emptying, it adds one more agent to review in the preoperative assessment for elective and emergency surgery.
Critical take: In REDEFINE 4 (phase 3, open-label, 809 randomized adults with obesity, 84 weeks, sponsored by Novo Nordisk) it failed to demonstrate non-inferiority in weight loss versus tirzepatide 15 mg, its primary endpoint (23.0% vs 25.5% by the efficacy estimand; 20.2% vs 23.6% by the treatment-regimen estimand, regardless of adherence). These are sponsor-reported data; weight loss is an intermediate outcome, and US approval does not guarantee availability or an affordable price in our setting.
Source: https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916501
Source: https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916470

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