Swiss robotics company Distalmotion has seen its Dexter surgical robot, designed for adult inguinal hernia repair, granted De Novo marketing approval by the US Food and Drug Administration (FDA).
The portable surgical robot is designed to treat adult inguinal hernia repair.
Distalmotion said that it wants its Dexter Surgical Robot to be regarded as “the surgeon’s robot” for its ease of use and ability to allow the physician complete control of the procedure by way of a sterile interface.So far, the robot has been used in Europe to treat more than 1,300 patients. According to the company, over 90 percent of inguinal hernia repairs are currently performed in the US.
Greg Roche, Distalmotion CEO, said: “We’re excited to bring Dexter to the US market and empower healthcare facilities with a robotic solution that addresses the barriers of cost, space, and workflow disruption. Our goal is to enhance existing practices with robotics that support—not disrupt—the way surgical teams operate.”
The marketing authorisation follows after the company was able to secure $90m in a funding round led by Revival Healthcare Capital. The capital is being used to drive the surgical robot to market.
Ryan Broderick, associate professor of surgery at University of California San Diego, said: “We are seeing the continued shift of procedures moving to the outpatient setting. The footprint and cost, both less than other solutions, enable Dexter to be the ideal robot for outpatient sites of care and those patients. Dexter is the solution for everyday surgeries and that’s what the market needs.”
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By GlobalDataElsewhere in the market of surgical robotics, medical device giant Johnson & Johnson (J&J) has submitted an investigational device exemption (IDE) to the FDA for its own surgical robot, dubbed Ottava, with the company looking to launch clinical trials.