Distalmotion received FDA de novo approval for its Dexter surgical robot for adult inguinal hernia repair. Lausanne, Switzerland–based Distalmotion can now bring Dexter to the U.S. with more than 1,300 patients already treated in Europe.
The company designed Dexter to deliver robotics’ benefits to more hospitals, outpatient departments and ambulatory surgical centers (ASCs). As a modular, small-format, open system, it offers simplicity and straightforwardness, plus more accessibility, according to the company.
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Distalmotion said Dexter can work natively with third-party 3D imaging systems, energy devices, vessel sealers and other laparoscopic devices. It features a suite of fully wristed, single-use instruments. These deliver dexterity, precision of movement, reliable instrument performance and lower reprocessing requirements.
The company says Dexter seamlessly integrates into existing workflows and works with current operating room equipment. The single-use instruments also remove the complexities of reprocessing to further enhance workflow efficiency. Dexter’s design enables quick, direct access to the patient from the sterile surgeon console as well. Distalmotion said it designed Dexter to be the “surgeon’s robot,” providing complete physician control for procedures.
Currently in day-to-day clinical use in Europe, Dexter could treat patients across complex and high-volume procedure types. That includes general surgery, gynecology and urology. Distalmotion raised $150 million last year to progress its regulatory efforts in the U.S. (The company featured on MassDevice’s list of 10 surgical robotics companies you need to know in 2024.)
In a news release, Dr. William Hope of the New Hanover Regional Medical Center (North Carolina) called inguinal hernia repair “an excellent first indication for Dexter.” Hope expects the design to “undoubtedly enable more patients to benefit from robotic-assisted surgery.”
“We’re excited to bring Dexter to the U.S. market and empower healthcare facilities with a robotic solution that addresses the barriers of cost, space, and workflow disruption,” commented Greg Roche, Distalmotion’s CEO. “Our goal is to enhance existing practices with robotics that support—not disrupt—the way surgical teams operate.”
