Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Prescient Surgical Wins FDA De Novo Clearance For CleanCision System

January 26, 2017 By Prescient Surgical

The FDA’s Center for Devices & Radiological health granted de novo clearance for Prescient Surgical’s CleanCision Wound Retraction and Protection System for surgical wound edge protection, retraction, and continuous cleansing with a sterile irrigant solution. The CleanCision device may also aid in the prevention of wound edge contamination, a powerful advance towards mitigating associated infections.

The CleanCision device, the first in a new category of irrigating wound protection devices classified by the FDA, provides access to the surgical site while protecting the incision with an impermeable barrier, defending against direct contamination. The device also facilitates intraoperative delivery of a sterile irrigant solution of the surgeon’s choice to the wound edge. With CleanCision, wound irrigation and wound protection, two independently proven strategies to prevent surgical site infection, are seamlessly combined into a single device.

(Image credit: Prescient Surgical)

Prescient Surgical was spun out of the Stanford Byers Center for Biodesign in 2012 to address the risk of surgical site infection (SSI), a serious complication associated with significant morbidity and mortality. SSI risk is generally 2-5 percent in the 30 million surgeries conducted annually in the U.S., but can be as high as 15-50 percent in certain high-risk, clean-contaminated, and contaminated procedures like colorectal surgery. Recent changes brought about by the Affordable Care Act, including public reporting and financial penalties, have heightened national focus on SSI prevention.

“This news from the FDA marks a crucial milestone for Prescient Surgical and validates the hard work put in by our team and clinical partners towards our mission of reducing the risk of SSI. Most importantly, we can now look toward extending the promising results we’ve seen in recent clinical trials to the broader patient population,” Prescient Surgical CEO Jonathan Coe said in a statement.

The timing of the de novo clearance is fortuitous. According to Brant Heise, Managing Director at Summation Health Ventures, “Hospitals are increasingly focusing on infection control to improve patient care as a primary goal. Prescient’s success with the CleanCision device bodes well for providers driven towards the ‘triple aim’ of quality of care, patient satisfaction, and reduced costs.”

Prescient Surgical plans to launch the CleanCision device in 2017.

Related Articles Read More >

Lazurite ArthroFree wireless surgical camera system Minnetronix Medical
How Minnetronix Medical helped Lazurite with its wireless surgical camera
Medtronic Hugo robot-assisted surgery system
The road to a robot: Medtronic’s development process for its Hugo RAS system
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A portrait of Stryker executive Tracy Robertson
Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
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

Enewsletter Subscriptions

Enewsletter Subscriptions

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
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • 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 E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. 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
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech