Distalmotion's DEXTER system cleared for ventral hernia repair
FDA 510(k) clearance expands DEXTER capabilities to four high-volume ambulatory procedures, completing Distalmotion's core outpatient portfolio.
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Manufacturer of robotic surgery systems
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In short: Distalmotion raised $150 million and secured multiple FDA clearances for its DEXTER robotic system to expand US surgical center access.
FDA 510(k) clearance expands DEXTER capabilities to four high-volume ambulatory procedures, completing Distalmotion's core outpatient portfolio.
The DEXTER Robotic Surgery System is cleared for sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection.
It follows SPARO trial completion. Clearance adds fourth US indication, second in gynecology, aiding outpatient procedures. CEO highlights outpatient robotics evolution.
The study documents the use of DEXTER® in robot-assisted partial nephrectomies with solid results in safety and performance.
US: The Distalmotion Dexter L6 System is intended for use in laparoscopic inguinal and ventral hernia repair, cholecystectomy, total benign hysterectomy including salpingo-oophorectomy, and sacrocolpopexy...
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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, sa...
The company is seeking clearance in additional gynecological indications to support outpatient use of its surgical robot.
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