TRXC - Asensus Surgical announces FDA clearance for Senhance Surgical System

Asensus Surgical, formerly TransEnterix, Inc. (TRXC) has announced that the company received an additional FDA clearance for the Senhance Surgical System sending TransEnterix shares ~28.1% higher in the pre-market.The regulatory approval for the digital laparoscopic platform leveraging machine learning to enhance patient outcomes allows for indication expansion in general surgery in the U.S., the company said.“The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology,” noted Anthony Fernando, Asensus Surgical CEO.“Including previous indications granted, the Senhance Surgical System can now be utilized in over 2.7 million general surgical procedures performed in the US annually."Indicated for use in adults, the system is intended for general laparoscopic surgical procedures and laparoscopic gynecological surgery.The FDA issued 510(k) clearance for Senhance Ultrasonic System in January 2019.

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Asensus Surgical announces FDA clearance for Senhance Surgical System