‘Ottava’ has been given market authorisation for use in multiple general surgery procedures within the upper abdomen.
Healthcare giant Johnson & Johnson has been granted ‘de novo’ approval by the US Food and Drug Administration (FDA) for what the company said is the world’s first table-integrated soft tissue robotic surgical system.
‘Ottava’ has been given market authorisation for use in multiple general surgery procedures within the upper abdomen, including gastric bypasses, gastrectomies, appendectomies and hiatal hernia repair.
When integrated into an operating theatre, the system’s four robotic arms occupy up to 50pc less space than ‘boom- and cart-mounted’ solutions for such environments, the company said. The system can also be programmed to help simplify set-up and breakdown of an operating theatre, or manipulate the positioning of a patient during a procedure.
Ottava also features a curated range of surgical tools and has its own “digital ecosystem” to support surgeons working with it, according to Johnson & Johnson.
“We are pioneering a new category of surgical robotics with Ottava,” said Tim Schmid, executive vice-president and worldwide chair of medtech at Johnson & Johnson.
“This is the start of the next era in surgery as we deliver not just a new surgical robotics system, but a catalyst for fundamentally better surgical care that is informed by technology, guided by clinical insight and delivered with care.”
The company said that Ottava – which will initially launch commercially with select US customers while aiming to advance into other use cases and regulatory jurisdictions – is purpose-built for present-day surgical procedures and environments while building a pathway to “support more digitally enabled, data-driven surgery in the future”.
Hani Abouhalka, the company’s group chair for surgery and medtech, said: “By opening up the way we think about architecture, data and the very workflows of surgery itself, we have designed Ottava to deliver clinical and economic benefits, and support surgeons and hospitals as the future of surgery unfolds.”
Earlier this week, US neural engineering company Science Corporation received EU approval for its vision-repairing medtech implant, Prima, with FDA approval processes also ongoing.
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