J&J’s Surgical Robot Wins US FDA Marketing Authorisation, Is It Affordable?

Johnson & Johnson said that the US Food and Drug Administration (US FDA) had granted marketing authorisation for its robotic surgery device. This marks the healthcare conglomerate’s entry into the soft-tissue robotic surgery market.

Johnson & Johnson’s Ottava robotic surgical platform received regulatory clearance for use across a variety of general abdominal surgical procedures. This includes procedures like gastric bypass, gastrectomy, gallbladder removal, gastric sleeve surgery, appendectomy, and hiatal hernia repair.

The company stated the robotic arms of the Ottava are built directly into the operating table. This makes them effectively use 30% to 50% less physical space than the standalone cart-and-boom setups utilised by most other surgical robots.

Johnson & Johnson is holding out its full commercial rollout until it obtains approvals for urological procedures.

Recent studies show that robot-assisted surgeries are generally more expensive. J&J, however, said it would begin a US commercial ​launch with select customers. It also revealed that expanding the system into additional regulatory markets is in the works.

While the timing has not been revealed yet, the CEO told Reuters, “Our intention is to lead in surgical robotics… we’re also planning fast launches in key markets globally, like ​Japan and Western Europe.”

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Studies consistently show the success rates, reduced operative times, and improved patient functional outcomes of AI robotic surgery. The company has yet to disclose pricing, and the initial robots are limited to a few select US customers. The pricing will tell if Johnson & Johnson can compete with established robotic surgery systems