• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Profound Medical lands FDA OK for prostate cancer trial

Profound Medical lands FDA OK for prostate cancer trial

September 18, 2013 By Brad Perriello

Profound Medical lands FDA OK for prostate cancer trial

Profound Medical said it won an investigation device exemption from the FDA for a clinical trial of its device to treat prostate cancer.

The Toronto-based medical device company said it hopes to begin enrolling patients later this year in the Tulsa trial.

The Profound device combines thermal ultrasound with real-time MRI guidance in a single outpatient session to treat localized prostate cancer, according to a press release.

"This is another exciting milestone for Profound Medical and we look forward to initiating our U.S. clinical trial in the coming months. The Tulsa trial is a key step in validating a new, alternative therapy for treating localized prostate cancer that minimizes the risks commonly associated with treatment," CEO Steven Plymale said in prepared remarks. "The objective of the Tulsa trial is to demonstrate that effective elimination of cancerous tissue can be achieved safely, precisely and with significantly less risk to bladder, bowel, and erectile functions."

Profound Medical launched a 30-patient Phase I trial of the device in Canada earlier this year.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Clinical Trials, Profound Medical Inc., Prostate

More recent news

  • EBR Systems raises $36.1M for leadless pacing tech
  • The biggest cardiovascular tech news out of EuroPCR 2025
  • CardiaWave has positive 12-month Valvosoft results
  • Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent
  • Medtronic has new Cardiovascular, CST leaders after longtime exec departs

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock 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.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. 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.

Privacy Policy