Second FDA Approval Within Weeks: Momentis Surgical, a medical device company that developed a small and mobile robotic system for a variety of surgeries that operates through a single incision, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the second generation of the company’s robotic surgery platform, Anovo. This marks Momentis' second FDA clearance within weeks, following the October announcement of 510(k) approval for the first generation of Anovo. The October approval expands the system’s capabilities for ventral hernia repair with a single incision, following prior approval for performing gynecological surgical procedures via a transvaginal approach.
The second generation of the Anovo platform, based on years of clinical insights, offers a package of upgrades that enhance the surgeon’s experience and ease of use. It is the first robotic system to receive FDA clearance (for both single or multiple incisions) for surgery in both forward flexion and backward flexion positions, providing unprecedented access and joint use through a single incision. Surgeons will now experience enhanced ergonomic capabilities with sensory feedback that enables intuitive control of the robotic arms during surgical procedures. Furthermore, a video layer that can incorporate annotations strengthens communication among the surgical team in the operating room, fostering collaboration and mutual learning.
Momentis Surgical received its first FDA approval for the Anovo system for a broad range of women’s health indications, including abdominal surgeries via the vaginal route, which reduce pain and the risk of infection, enabling faster recovery without leaving scars. This system is the first and only one to receive FDA approval for minimally invasive robotic surgeries with robotic arms that resemble human arms, providing fine motor skills at a human level, with 360-degree rotation joints and flexibility in multiple planes. The surgical tools are designed to mimic the movements and capabilities of a surgeon’s arms, with shoulder, elbow, and wrist joints. Multiple instruments can be inserted into the patient through a single incision, and the 360-degree rotation allows avoidance of obstacles as well as optimal working angles and access.
Momentis Surgical, founded and led by Dvir Cohen, is revolutionizing the field of robotic surgery by developing innovative and miniature robotic technologies for an expanding range of medical applications. The company’s goal is to provide surgeons with tools to perform complex, minimally invasive surgeries that will enable better outcomes for patients, reduce costs, and allow access to more surgeons, patients, hospitals, and surgical centers worldwide to robotic surgery. Among Momentis Surgical's investors are leading life sciences investment firms, including Peregrine Ventures, OurCrowd, Ceros, and Accelmed.
Dvir Cohen, CEO and Co-Founder of Momentis Surgical, said: “The advancement of technology and the expansion of surgical indications highlight our commitment to a long-term program to revolutionize the field of robotic surgery. The FDA approval is another milestone in the execution of our multi-year plan to take robotic surgery to the next level. We are on a strong momentum following impressive clinical trial results in gynecological surgery. Along with these improvements, we are striving to expand our global presence and will soon present Anovo in European and Asian markets.”
Eyal Lifshitz, Managing Partner of Peregrine Ventures, which has been supporting Momentis Surgical since its founding, added, “We have managed to build a large number of successful companies in our incubator, including Momentis, which has the potential to change the status quo in robotic surgery. The Anovo system will expand access to robotic surgery to a larger number of surgeons in more medical institutions, including outpatient surgical centers, thanks to the compact size and user-friendliness of the multidisciplinary system.”