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TransEnterix's digital laparoscopy device gets green light from FDA

The company's Senhance Ultrasonic system is approved for use in the US for laparoscopic colorectal, gynecological and gallbladder removal surgery
a pair of surgeons
Senhance is used for some of the most common abdominal surgeries, including procedures in general surgery and gynecology

TransEnterix Inc (NYSEAMERICAN:TRXC), the medical device company, is on the receiving end of good news from the US Food and Drug Administration which has granted 510(k) clearance for its Senhance Ultrasonic system, its digital laparoscopy device.

TransEnterix is the maker of surgical robots and medical instruments used in minimally invasive surgery. It’s focused on commercializing its Senhance Surgical Robotic System, which gives surgeons greater haptic or tactile feedback, and eye sensing camera control.

READ: TransEnterix shares pop after FDA clears robotic surgery instruments

Senhance is also the first robotic surgical system to offer reusable instruments as well as 3 mm instruments for micro laparoscopic procedures that permit virtually scar-less incisions for patients.

“Advanced energy devices are used within a high percentage of cases across a wide range of procedures, which make them a critical tool for laparoscopic surgeons,” noted Todd Pope, TransEnterix CEO in a statement.

“We believe the addition of the Senhance Ultrasonic system is significant and broadens the attractiveness of the Senhance platform and digital laparoscopy for surgeons in the US,” Pope added.

READ: TransEnterix posts bigger 2Q loss although revenue tops expectation

Investors applauded the news, sending TransEnterix shares up 7.14% to $2.85 in pre-market trade on Tuesday.

The Senhance Ultrasonic system is now available in the U.S., where it is approved for use in laparoscopic colorectal, gynaecological and gallbladder removal surgery. It is also on offer in countries that accept a CE Mark, which was earned last year.

Based in Morrisville, North Carolina, TransEnterix seeks to improve procedures for minimally invasive surgery.

Contact Ellen Kelleher at [email protected]

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