A Leap into the Future: FDA Greenlights Transformative Advances in Robotic Surgery

by Dominika Wilczok          Biopharma insight

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Topics: Emerging Technologies   
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Recently, the robotic surgery industry was marked by two important announcements. On February 22, 2024, FDA granted 510(k) clearance to Zimmer’s ROSA shoulder-replacement robot. 

Image credit: iStock, PhonlamaiPhoto

This will be the world's first such robotic-assisted surgery (RAS) setup. It is planned to launch commercially after June 2024, becoming the 4th element in Zimmer’s robotic joint replacement line. 

With the main goal being reducing complications and improving efficiency, Zimmer positions itself as a market leader for countering joint-failure-related frailty in an aging population. 

However, the ROSA line is not just a surgical robot; it allows surgeons to prepare by walking through the surgery case by case, aligned with the vision of longevity medicine: tailored interventions elongating healthspan. During the procedure, ROSA provides inter-operative data which helps to validate the decisions, and further minimize unnecessary damage.

Another important milestone is that FDA granted clearance via the de novo pathway for colectomy (large intestine surgery) procedures to Virtual Incision following their exorbitant success: simulated robotic-assisted surgery on the International Space Station. 

Not surprisingly, the robot spaceMIRA, reached the ISS via a SpaceX vehicle; Elon Musk’s Neuralink chip was also placed in the brain using RAS. 

spaceMIRA, developed in collaboration with NASA and the University of Nebraska,  is the world’s first miniaturized robotic surgical system. It is half a ton lighter than the pioneer in the field, the Da Vinci S robot by Intuitive. 

Surgeons operated spaceMIRA from Earth, while the robotic arms were moving in space, operating on a set of rubber bands that were to mimic a soft-tissue surgery. 

Virtual Incision made a notable leap forward by showing that surgeons don’t even need to be in the same room as the patient to do their job, or even… the same planet. 

This achievement provides hope for improving healthcare access around the world. Roughly 52% of the population don’t have access to essential healthcare. The miniaturized robotic surgery systems allow for unprecedented portability (they weigh less than some laptops) which provides an outlet for increasing the access for safe surgery. 

Combining it with the long-distance capabilities of spaceMIRA, Virtual Incision opened the door for  redefining surgery. Making theoretical scenarios, it could even help in conflict or natural disaster areas; surgeons could focus in a safe building far away from the catastrophe site, while MIRA operates in real-time. The robot could be delivered by drones, and set up by others, instructed via videoconferencing. 

In the area of “small in size, but huge in potential” robotic surgery Medical Micro Investments (MMI) raised $110 million in Series C financing, which is the largest investment in the realm of microsurgery to date. 

This round was led by Fidelity Management & Research Company which encompasses Fidelity® Disruptive Medicine ETF (FMED) and Fidelity® Digital Health ETF (FDHT), both having robotic surgery portfolios. 

Not yet FDA-cleared, MMI’s Symani robot is planned to have a broad range of applications including lymphatic, microvascular, and peripheral nerve surgery. Publishing many preclinical papers and case studies about their product application, MMI shows that the surgeries performed with the Symani robot, as opposed to the manual groups, score better on the Rapid Entire Body Assessment regarding possible postoperative complications. 

The movement in the regulatory-body approvals brings us a step closer to robotic surgery becoming a common practice. The next step is autonomous robotic surgery for which advancements are also underway. 

 

Topics: Emerging Technologies   

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