原文標題：
Asensus Surgical (TRXC) Announces FDA Clearance in General Surgery
原文連結：https://bit.ly/3q9VDlV
發布時間：March 3, 2021 6:55 AM EST
原文內容：
Asensus Surgical, Inc. (formerly TransEnterix, Inc.) (NYSE American: TRXC) ,
a medical device company that is digitizing the interface between the surgeon
and patient to pioneer a new era of Performance-Guided Surgery™, today
announced the Company has received an additional FDA clearance for the
Senhance Surgical System which allows for indication expansion in general
surgery in the United States.
Asensus Surgical's technology platform, Senhance® Surgical System, is the
first of its kind digital laparoscopic platform that leverages augmented
intelligence to provide unmatched performance and patient outcomes through
machine learning. Senhance goes beyond the typical surgical robotic systems,
providing surgical assurance through haptic feedback, eye-tracking camera
control, and 3D visualization, and is the first platform to offer 3 mm
instruments (the smallest instrument available in the world on a robotic
surgical platform).
“The expansion into general surgery for the Senhance Surgical System is a
major milestone for the growth and clinical applicability of our technology,”
said Anthony Fernando, Asensus Surgical President and CEO. “General surgery
is, by far, the largest area of manual laparoscopy which can benefit from the
precision and insight of Performance-Guided Surgery. The indication expansion
allows Senhance to be used in many high-value, complex reconstructive
surgeries such as those used to treat reflux and obesity. 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."
“Many of the procedures we perform in general surgery require complex
reconstruction throughout a wide surgical field,” said Dr. Sabino Zani,
Assistant Professor of Surgery at Duke University and an investigator in the
clinical studies submitted for indication expansion. “Senhance can now be
seen as a widely applicable tool for general surgeons across the broad range
of procedures that may be performed from deep in the pelvis to the upper
abdomen.”
Senhance US Indication for Use
The Senhance Surgical System is intended to assist in the accurate control of
laparoscopic instruments for visualization and endoscopic manipulation of
tissue including grasping, cutting, blunt and sharp dissection,
approximation, ligation, electrocautery, suturing, mobilization, and
retraction. The Senhance Surgical System is intended for use in general
laparoscopic surgical procedures and laparoscopic gynecological surgery. The
system is indicated for adult use. It is intended for use by trained
physicians in an operating room environment in accordance with the
instructions for use.
心得/評論： ※必需填寫滿20字
前陣子的飆股,雖然二月有滿滿的預期會通過FDA 但大漲大跌之下還是賣了一點
部位.這陣子的回調原本希望回到3.5再加倉,這下看來沒機會了..