Distalmotion is in search of FDA approval to be used of DEXTER
Distalmotion has filed a 510(ok) software with the U.S. Meals and Drug Administration (FDA) in search of authorization to make use of the DEXTER robotic surgical procedure system for sacrocolpopexy, sacrocervicopexy and endometriosis resection.
The entry comes after completion of the Robotic Sacrocolpopexy and Sacrocervicopexy trial, referred to as SPARO, which assessed DEXTER in these procedures.
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If the company approves the submission, it might change into the fourth normal and second gynecologic indication for DEXTER within the US, supporting broader growth of service strains in ambulatory surgical facilities (ASCs).
Distalmotion mentioned procedures proceed to maneuver from hospitals to outpatient settings, reflecting doctor, payer and affected person preferences. In that shift, robotics is used to assist migration.
For ASCs creating gynecology applications, broader robotic indications might allow hysterectomy, sacrocolpopexy, and different benign gynecology procedures inside the identical working day.
The FDA has licensed the corporate to provoke a U.S. myomectomy trial by an investigational system waiver (IDE), supporting additional developments in its gynecology medical program.
Distalmotion CEO Greg Roche mentioned: “Increasing gynecology capabilities in outpatient settings represents an essential subsequent step within the evolution of the DEXTER robotic program.
“DEXTER is designed to assist outpatient clinics introduce robotics in a sensible method, permitting healthcare groups to construct sustainable service strains throughout a number of specialties.”
DEXTER is a delicate tissue surgical system with single-use wrist devices designed to assist precision and dexterity.
The cellular design matches into working rooms with out modification, whereas a sterile console and open structure assist versatile workflows and expertise compatibility.
In November 2025, Distalmotion closed a Collection G funding spherical totaling $150 million to speed up DEXTER’s US enlargement.
