US FDA marketing authorization for miniaturized robotic-assisted surgery device: Virtual Incision

Virtual Incision, a subsidiary of cultivate (MD), has received marketing authorization from the US FDA for the MIRA Surgical System (MIRA), marking a significant milestone. MIRA is now the first miniaturized robotic-assisted surgery device in the world approved for adult colectomy procedures.

Virtual Incision sees MIRA's innovative design as potentially transformative in the field of surgical technology. Weighing less than two pounds and featuring a user-friendly tray-to-table setup, MIRA is intended to enhance operating room efficiency. This approach aims to make robotic surgery more accessible across various healthcare settings, addressing logistical challenges posed by larger surgical robots currently in use.

With US FDA approval secured, Virtual Incision is poised to launch MIRA commercially in selected centres across the United States.

The broader commercialization of MIRA and its expansion into other medical fields, including gynaecology, general surgery, urology, and various soft tissue and solid organ surgeries, are part of the company's roadmap. Furthermore, a new iteration of the technology customized for general surgery is currently in development and is anticipated to undergo a first-in-human study outside the US later this year.