Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Senhance Robotically-Assisted Surgical System Earns FDA Clearance

October 17, 2017 By Daniel Seeger

Intuitive Surgical became one of the behemoths of the healthcare industry due to their absolute dominance of one emerging fixture of the OR: robotically-assisted surgical devices. While the company’s da Vinci Surgical System remains the standard, there are a group of upstart manufacturers ready to offer a challenge, and one of them recently cleared an important regulatory hurdle.

Late last week, the FDA announced the Senhance System, manufactured by TransEnterix Surgical, received clearance for use on adult patients.

The manufacturer celebrated the milestone, noting the Senhance becomes the first new abdominal surgical robotics device to enter the U.S. market in 17 years.

“Millions of surgical procedures in the U.S. are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort, and control,” TransEnterix president and CEO Todd M. Pope said in a press statement accompanying the announcement. “New choices are needed that enhance the senses, control, and comfort of the surgeon, minimize the invasiveness of surgery for the patient, and maximize value for the hospital. Senhance is this new choice.”

The general benefits of robotically-assisted surgical devices are familiar to most surgeons by now, leading TransEnterix to emphasize more unique features such as their eye-sensing camera control, which they say is emblematic of the heightened connection between humans and technology that the Senhance provides.

(Image credit: TransEnterix)

Last year, TransEnterix changed the name of the device from the less-descriptive ALF-X to Senhance, specifically to emphasize the system as a tool developed to draw on the talents of a surgeon.

“Senhance is designed to enhance laparoscopic surgery and specifically empowers the senses of the surgeon in ways that were never previously possible,” Pope said at the time. “The security of haptics and the convenience of eye sensing camera control are meaningful ways that technology can provide a further extension of the surgeon’s skill.”

The FDA clearance is especially triumphant for TransEnterix as it represent the end of an extended turnaround. The company was previously rebuffed by the FDA after submitting the SurgiBot System for U.S. regulatory approval. That setback resulted in a class action lawsuit filed by investors who claimed they were misled about the progress of the device. That legal action was dismissed mere days before the FDA gave the green light to U.S. sale of the Senhance.   

Even with the cascade of good news, TransEnterix has its work cut out for it to make headway in a highly specialized market where healthcare professionals might be loathe to stray from a rival that is far more well established. Although the Senhance has been approved for sale and use in other parts of the world for some time, The Motley Fool reports that TransEnterix sold only two systems in the first half of 2017.

Related Articles Read More >

This is a Zimmer Biomet marketing image of its Rosa robotic surgery system.
Zimmer Biomet seeks a ZBEdge for its Rosa robotic surgery
A photo of Capstan Medical's mitral valve implant, which uses nitinol.
Capstan Medical’s R&D head discusses the heart valve and robotics startup’s tech, engineering challenges and solutions, advice for others in medtech and how to join his team
An illustration of a neurosurgeon using a robotic endoscope to remove a brain tumor.
MDO Nitinol Innovation Special Report
A photo of Highridge Medical CEO Rebecca Whitney.
Highridge Medical is betting on this spine tech
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe