Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. If the trial goes well, Ottava could pose a significant challenge to decades-long dominance of the robotic surgical market by Intuitive Surgical Inc.’s Da Vinci system.
CMR Surgical Ltd. recently submitted its application to the U.S. FDA for approval for its Versius surgical system as it seeks to get more surgeons using the small, portable, robotic tool in laparoscopic procedures.
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
Intuitive Ventures, the investment arm of Intuitive Surgical Inc., closed a $150 million fundraising round for its second fund, which will focus on investments in startups in three areas: precision diagnostics and interventions, digital ecosystems and improving health care access and coordination. Intuitive Surgical’s first venture fund raised $100 million that has been used to support more than 10 early-stage companies.
Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.
Microsure BV recently secured €38 million (US$40 million) in a series B2 funding round that will allow it to finalize the development of its microsurgical robot, the Musa-3. The robot system is designed to give microsurgeons the precision, stability and control that are currently beyond human capabilities. “We want to make a super microsurgeon from every microsurgeon,” Sjaak Deckers, CEO of Microsure, told BioWorld.
CMR Surgical Ltd. raised $165 million in financing from its existing investors that will allow the company to continue to innovate its portable robotic surgery system, Versius, and grow its position in existing and new markets. The latest financing takes CMR’s total capital raised since its founding to over $1 billion. The Versius surgical robotic system is now in over 20 markets and the company has become the second largest soft tissue surgical robotics company globally, after Intuitive Surgical Inc.
Largely underserved pediatric surgery patients in the U.S. could benefit from a new digital laparoscopic surgery solution said its developer Asensus Surgical Inc. Granted a pediatric indication by the U.S. FDA for the Senhance system in late March, the company plans to enter a market that has been largely ignored because of the difficulty performing digital laparoscopic surgery on smaller body patients.
Creo Medical Group plc is on its way to being cash flow breakeven and profitable following a successful fundraise, which will accelerate the rollout of its suite of electrosurgical products, CEO Craig Gulliford told BioWorld.
A French surgical team has performed a robot-assisted kidney auto-transplantation with ex situ tumorectomies for renal cell cancer. This is the world first use of the fourth generation Da Vinci Xi surgical robot from Sunnyvale, Calif.-based Intuitive Surgical Inc. to perform kidney explanation and autotransplantation with removal of multiple and complex tumors outside of a patient's body.
