There have been some huge rumblings in the surgical robotics space recently. The latest noise is being made by Vicarious Surgical – which has announced filing pre-submission to FDA.

The Waltham, MA-based company is developing surgical robots that combine human-like mechanical arms with virtual-reality technology that the company said essentially acts to “transport surgeons inside the patient when performing minimally invasive surgery.”

Vicarious won breakthrough device designation for the robotically-assisted surgical solution in December of 2019.

In an investment thesis, Ryan Zimmerman, a BTIG analyst wrote, “the Vicarious Surgical system features more degrees of freedom per arm for enhanced reach and anatomical access, smaller ports for smaller incisions and quicker recovery, 360 degrees of view, and an overall smaller footprint to fit into any operating suite. We believe these features will appeal to physicians and hospitals alike with much more to come following initial clearances.”

Zimmerman added, “Vicarious Surgical’s initial focus is on the fast-growing robotic hernia market, which remains underpenetrated. We expect Vicarious Surgical to have its first indication in FY23, with other indications to follow shortly thereafter.”

Vicarious went public through a Special Purpose Acquisition Corporation merger with D8 Holdings in a deal valued at $1.1 billion in April.

“This quarter marks our entry into the public markets, and I am incredibly proud of our teams and employees for their contributions to our company’s growth to date. We are well-positioned to continue development of our next generation robotics system and are also pleased to announce that we have just filed a detailed regulatory plan in the form of a pre-submission to FDA,” said Adam Sachs, CEO of Vicarious Surgical. “We remain committed to transforming outcomes for surgeons and patients alike, and today, we are one step closer.”

Surgical robotics have been a hot-button topic in medtech lately. Medtronic began stirring the pot when it announced winning CE mark for the Hugo robotic-assisted surgery (RAS) system.

If that wasn’t enough, the space went into a further frenzy when, just days after the news about Hugo, Johnson & Johnson announced it was delaying the Ottava RAS solution.

Article source: Qmed and MD+DI