close
close

Association-anemone

Bite-sized brilliance in every update

Momentis Surgical Receives FDA Approval for Second Generation Anovo Robot
asane

Momentis Surgical Receives FDA Approval for Second Generation Anovo Robot

Second FDA approval in weeks: Momentis Surgical, a medical device company that has developed a small, mobile robotic system for a variety of single-incision surgeries, announced today that the US Food and Drug Administration (FDA) has granted 510(k) clearance ) for the second generation. the company’s robotic surgery platform, Anovo. This marks Momentis’ second FDA clearance in as many weeks, following the October announcement of 510(k) approval for the first generation of Anovo. The October approval expands the capabilities of the single-incision ventral hernia repair system, following prior approval for transvaginal gynecological surgical procedures.

The second generation of the Anovo platform, based on years of clinical insights, offers a package of upgrades that improve the surgeon experience and ease of use. It is the first robotic system to receive FDA clearance (for both single and multiple incisions) for surgery in both forward and posterior flexion positions, providing unprecedented joint access and use through a single incision. Surgeons will now experience enhanced ergonomic capabilities with sensory feedback that enables intuitive control of robotic arms during surgical procedures. Additionally, a video layer that can embed annotations strengthens communication between the surgical team in the operating room, fostering collaboration and mutual learning.

Momentis Surgical received the first FDA approval for the Anovo System for a wide range of women’s health indications, including vaginal abdominal surgeries, which reduce pain and risk of infection, allowing for faster recovery without scarring. This system is the first and only FDA-cleared for minimally invasive robotic surgery with robotic arms that resemble human arms, providing human-level fine motor skills with 360-degree rotatable joints and multi-plane flexibility. Surgical instruments are designed to mimic the movements and capabilities of a surgeon’s arms, with shoulder, elbow and wrist joints. Several instruments can be inserted into the patient through a single incision, and the 360 ​​degree rotation allows avoiding 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, miniature robotic technologies for an expanding range of medical applications. The company’s goal is to provide surgeons with the tools to perform complex, minimally invasive surgeries that will enable better patient outcomes, lower costs, and enable more surgeons, patients, hospitals and surgical centers around the world to access robotic surgery . Momentis Surgical’s investors include leading life sciences investment firms including Peregrine Ventures, OurCrowd, Ceros and Accelmed.

Dvir Cohen, CEO Momentis Surgical (credit: Momentis Surgical)

Dvir Cohen, CEO and co-founder of Momentis Surgical, said: “The advancement of technology and expanding 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 strong momentum following impressive clinical trial results in gynecological surgery. With these improvements, we are working to expand our global presence and will soon introduce Anovo to the European and Asian markets.”

Eyal Lifshitz, Managing Partner of Peregrine Ventures, which has backed Momentis Surgical since inception, added: “We have been able 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 greater number of surgeons in multiple medical institutions, including ambulatory surgery centers, due to the compact size and ease of use of the multidisciplinary system.”