※ 本文轉寄自 ptt.cc 更新時間: 2021-03-03 21:24:22
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作者 標題 [新聞] TRXC 通過 FDA 了
時間 Wed Mar 3 20:49:50 2021
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..
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推 : 連續兩篇 那個停損的撐的住嗎...1F 03/03 20:51
推 : 快笑,免得人家說我看不懂2F 03/03 20:52
推 : 盤前30%3F 03/03 20:54
推 : 昨天清了1/3的倉 有夠靠北4F 03/03 20:54
→ : 這幾天壓價是內褲線吧
→ : 這幾天壓價是內褲線吧
推 : 牛排加大加大再加大6F 03/03 20:55
→ : 我3.2賣在6塊 後來4.2進了一點看3.8就拋了那批..7F 03/03 20:56
→ : 專利、FDA都通過了 這下就看財報了
→ : 專利、FDA都通過了 這下就看財報了
推 : 厲害了!9F 03/03 20:57
推 : 機器人手術過FDA了 有3D成像技術 還有作用力回饋10F 03/03 20:57
→ : 醫材過fda有很大利多嗎?11F 03/03 20:58
推 : 上面那篇停損的要哭惹12F 03/03 20:58
→ : 昨天漲的根本偷跑啊
→ : 昨天漲的根本偷跑啊
推 : 5塊買的本來想說沒救要抱10年惹 沒想到一週就能吃14F 03/03 21:00
→ : 牛排惹
→ : 牛排惹
推 : 毛票皇這隻不知道還有沒有留著16F 03/03 21:00
推 : 這幾天從6塊跌到3.x塊,沒賣的不是有信仰再不然就17F 03/03 21:05
→ : 是沒停損腳麻的
→ : 是沒停損腳麻的
→ : 靠,昨天想了半小時買不下手....19F 03/03 21:07
推 : 盤前+32% 酸民還在酸喔20F 03/03 21:07
噓 : 狂21F 03/03 21:08
推 : 最多一筆-25%也沒賣 我連我買的是啥公司都不知道 XD22F 03/03 21:10
推 : to the moon 了23F 03/03 21:10
推 : 財報也要至少半年才會發酵吧,目前只有約一百位24F 03/03 21:11
推 : 不是早就已經知道的消息嗎?25F 03/03 21:11
→ : active users, 一年只有約四千次手術,實在少得可憐26F 03/03 21:11
推 : 舒服,停損的好笨27F 03/03 21:12
推 : 毛票皇皇說的其實有道理 他真的能跟達文西手臂拼市28F 03/03 21:13
→ : 佔他就不會是毛票了啦
→ : 佔他就不會是毛票了啦
推 : 可惜 本來想說昨天下跌要再加碼一點30F 03/03 21:15
推 : 不要拿賓利比神A,好嗎?31F 03/03 21:15
推 : 財報應該會很難看,他這個時候發布這個消息很厲害。32F 03/03 21:16
→ : 可以用這個大消息壓過財報難看的窘況
→ : 可以用這個大消息壓過財報難看的窘況
推 : 我跟ze有同感,而且這支這幾天大跌沒被甩掉(只是睡34F 03/03 21:17
→ : 前有點小抖),今天盤前直接噴過成本,有點不知道該
→ : 不該出
→ : 前有點小抖),今天盤前直接噴過成本,有點不知道該
→ : 不該出
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