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Johnson & Johnson wins FDA exemption for Ottava surgical robotic


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Johnson & Johnson wins FDA exemption for Ottava surgical robotic

Whereas Johnson & Johnson has principally saved its Ottava surgical robotic beneath wraps, it mentioned the system affords surgical groups the liberty and adaptability to adapt to medical workflows and individualize affected person wants. | Supply: Adobe Inventory

Johnson & Johnson MedTech introduced right now that the U.S. Meals and Drug Administration granted its Ottava surgical robotic investigational gadget exemption, or IDE.

The regulatory nod comes just below a month after the corporate mentioned it submitted Ottava for IDE. It permits Johnson & Johnson MedTech to start a medical trial for the robotic platform at U.S. websites. The corporate is now making ready medical trial websites to obtain Ottava techniques, enroll sufferers, and start surgical instances.

Johnson & Johnson first shared particulars on the Ottava surgical robotic platform about 4 years in the past. Nonetheless, since then, the corporate has remained quiet on the subject, although. In October 2021, J&J pushed again the platform’s growth timeline by about two years attributable to a number of components.

The preliminary unveiling of Ottava highlighted a six-armed strategy for the robotic. A November 2023 replace shed extra gentle on Ottava and a few adjustments in its look over the previous three years.

The corporate mentioned Ottava incorporates 4 robotic arms right into a standard-size surgical desk. Its unified structure permits for an “invisible design,” in keeping with J&J. The robotic arms can be found when wanted and are stowed beneath the surgical desk when not.

Johnson & Johnson MedTech mentioned the design removes obstacles to motion and collaboration in robotic working rooms. It additionally affords surgical groups the liberty and adaptability to adapt to medical workflows and individualize affected person wants.

“We’re bringing the very best of J&J MedTech’s surgical procedure experience to the Ottava system and taking a holistic view of the science of surgical procedure to allow new experiences throughout all surgical modalities in service of sufferers all over the world,” mentioned Hani Abouhalka, group chair for surgical procedure at Johnson & Johnson MedTech. “Assembly this milestone brings us a step nearer to delivering on our promise to make expertise extra human, care extra adaptive, and folks extra linked in order that surgical procedure works higher for everybody.”


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Johnson & Johnson designs Ottava for versatility

Johnson & Johnson mentioned it designed Ottava to set a brand new normal for the fashionable working room and rework the surgical expertise. The system’s distinctive structure combines with J&J’s digital ecosystem to ship versatility in assembly affected person and surgeon wants.

With the 4 low-profile robotic arms, the corporate designed Ottava to help robotic, laparoscopic, hybrid, and open surgical procedure with extra working house for medical groups. The system’s structure helps options like “twin movement” wherein the desk and robotic arms transfer collectively. This aids in intraoperative repositioning and multi-quadrant entry with out re-docking.

Ottava additionally completely options trusted Ethicon instrumentation designed for efficiency and precision. J&J mentioned this helps a extra constant expertise between conventional laparoscopic and robotic procedures.

The corporate mentioned its Polyphonic digital ecosystem can join the portfolio throughout surgical applied sciences, robotics, and software program whereas additionally utilizing its scale.

Sooner or later, J&J mentioned it expects Polyphonic to empower Ottava with knowledge and superior insights. This may help medical decision-making, studying and collaboration.

“We’re enthusiastic about reaching this essential milestone and progressing our differentiated normal surgical procedure robotic platform for the good thing about sufferers and surgeons,” mentioned Rocco De Bernardis, president of Ottava at Johnson & Johnson MedTech. “With approval to maneuver to medical investigation, our groups are centered on coaching medical trial investigators and groups as they enroll sufferers and put together for instances.”

Editor’s observe: This text was syndicated from The Robotic Report sibling web site MassDevice

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