Swiss medical device company Distalmotion has secured the US Food and Drug Administration (FDA) 510(k) clearance for its DEXTER robotic surgery system, covering sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection.
These new indications build on previous US authorisations that included hysterectomy and salpingo-oophorectomy for gynaecological use.
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DEXTER also holds clearances for general surgery procedures such as inguinal hernia repair and cholecystectomy in the US.
The authorisation represents the DEXTER system’s second FDA clearance relating to gynaecology and fourth overall in the US.
The company says the expansion of indications now enables providers at ambulatory surgery centres (ASCs) to broaden their gynaecological surgery portfolios.
These outpatient sites, where operational efficiency is a priority, may now address a wider range of women’s health conditions using robotic platforms.
The system enables surgeons to perform procedures robotically for different gynaecological conditions in outpatient settings.
Distalmotion CEO Greg Roche said: “Securing FDA clearance for these additional GYN indications is another important milestone for the DEXTER programme.
“By enabling a comprehensive GYN service line, we are empowering care teams to maximise their workflows and deliver the combined benefits of robotics and same-day care to a broader patient population.”
Alongside this commercial update, Distalmotion reported it is progressing with its US investigational device exemption (IDE) study evaluating DEXTER in myomectomy.
The company stated that more than 4,000 patients have already been treated using the system.
DEXTER is described as a soft tissue surgical robot designed to perform laparoscopic procedures across urological, general, and gynaecological fields.
The system features a range of single-use robotic instruments and a compact size intended for easy integration into various operating rooms.
In the US, DEXTER is authorised for use in adult patients, defined as 22 years and older, across the specified laparoscopic procedures.
In January 2024, Distalmotion announced a partnership with health technology platform Proximie to globally extend the capabilities of its Dexter robotic surgery system.
