The FDA has granted de novo classification to the robotic system for soft tissue manipulation in microsurgery.
Robotics company Medical Microinstruments (MMI) has secured approval from the US Food and Drug Administration (FDA) for its Symani Surgical System.
The system enables surgeons to perform microsurgery and super-microsurgery by replicating human hand movements on a tiny scale. It broadens treatment options for soft tissue and open surgeries and is expected to enhance the quality of life for patients. It is also designed to encourage surgeons to perform complex surgeries on delicate anatomy while allowing hospitals to expand their surgical offerings.
The FDA has granted de novo classification to the robotic system for soft tissue manipulation in microsurgery, a technique involving intricate vessel reconnection to restore blood flow or redirect fluids during reconstruction or repair.
In February 2024, MMI secured $110m in a Series C financing round, led by Fidelity Management & Research Company, to support the expansion of clinical evidence and indication for the Symani Surgical System.
MMI is continuing to expand the global commercialisation of the Symani Surgical System. In October 2023, the company signed two new distribution agreements – with Device Technologies and TRM Korea – covering 11 countries in the Asia Pacific (APAC) region. The company teamed up with Italian medical technology production and distribution company Ab Medica earlier this year.
According to GlobalData forecasts, the total surgical robotics market was worth $4.6bn in 2020 worldwide. By 2030, it will have grown at a compound annual growth rate (CAGR) of 8.5% to $10.3bn, bolstered by the coming marriage of AI and robotics within medical devices.
The US is potentially facing a shortage of physicians which will impact specialised fields of medicine, including microsurgery, said MMI’s CEO Mark Toland in the 8 April press release.
“With the authorisation from the FDA, our technology will expand its reach to pioneering hospitals in the US. It will help those hospitals grow their open surgical programs, expand the number of physicians who can perform these highly complicated procedures, and increase patient access to the most advanced techniques for surgeries in complex disease states such as lymphedema,” adds Toland.
