The US Food and Drug Administration (FDA) has granted 510(k) clearance for Distalmotion’s DEXTER robotic surgery system to be used in adult cholecystectomy (gallbladder removal) procedures, marking its second approved indication in the country.
The clearance follows a previous de novo clearance for inguinal hernia repair in Q4 2024.
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Distalmotion CEO Greg Roche said: “With indications for inguinal hernia repair and now cholecystectomy, we’re meaningfully building the reach of DEXTER in the US so that more surgical teams and patients will benefit from robotic surgery.”
According to the company, cholecystectomy is one of the most common general surgeries in the US, typically performed in outpatient departments and ambulatory surgery centres (ASCs).
With a shift towards outpatient settings for soft tissue procedures, there is a high demand for robotic systems that provide precision.
Specifically intended for outpatient settings, DEXTER meets this demand, offering a small, mobile footprint that allows it to fit into an operating room (OR).
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By GlobalDataThe system integrates into existing workflows to facilitate high-volume procedures, and its suite of fully wristed single-use robotic instruments is designed to improve precision in surgical procedures.
DEXTER’s sterile console enables surgeons to remain close to the patient, facilitating quick access to the bedside and transitions between laparoscopic and robotic methods.
The system features an open architecture that is compatible with current and future OR technologies, supporting cost-effective supply chain operations.
In Europe, it is indicated for use in various laparoscopic surgical procedures, including urologic, general, and gynaecologic surgeries.
It is also indicated for laparoscopic inguinal hernia repair and cholecystectomy in adults aged 22 and above in the US.
Distalmotion noted that DEXTER has been leveraged in 2,000 procedures across more than 30 types of surgical procedures, expanding its presence in the US and Europe.
The company is further extending its reach in the US market with the completion of its pivotal HYPER trial for benign hysterectomy and ongoing subject enrolment in its sacrocolpopexy trial.
