• 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 » FDA clears more Chocolate PTA balloon catheters | Regulatory Roundup

FDA clears more Chocolate PTA balloon catheters | Regulatory Roundup

June 19, 2012 By MassDevice staff

MassDevice.com Regulatory Roundup

 TriReme touts FDA okay for more Chocolate PTA balloon catheters
Pleasanton, Calif.-based vascular devices maker TriReme Medical won expanded FDA indication for additional sizes of its Chocolate percutaneous transluminal angioplasty balloon catheters.

"This latest regulatory approval broadening the available size matrix of the Chocolate PTA balloon marks yet another important milestone for TriReme Medical," president & CEO Eitan Konstantino said in prepared remarks. "There is more to come; our goal is to provide a broad range of innovative tools to improve outcomes in patients suffering from complex vascular disease."

TriReme initially won 510(k) clearance late last year for the Chocolate line of devices to treat occluded peripheral arteries.
Read more

 InTouch lands 510(k) win for remote cute care systems
Santa Barbara, Calif.-based InTouch Health won expanded FDA 510(k) clearance for a range of its telemedicine systems to enable active patient monitoring in environments where immediate clinical action may be required. The new clearance specifically targets surgical, cardiovascular, neurological, pre-natal, psychological and critical care monitoring, assessment and examination.
Read more

 Maquet wins CE mark for new anti-microbial vascular graft
Maquet Cardiovascular won CE Mark approval in the European Union for its Intergard Synergy vascular graft, made with anti-microbial compounds to prevent vascular graft infections.
Read more

Filed Under: 510(k), Food & Drug Administration (FDA), News Well Tagged With: InTouch Health, Maquet Cardiovascular LLC, Remote Patient Monitoring, TriReme Medical Inc.

More recent news

  • Neuralink files to raise $649M in new equity offering
  • BofA: Surgical robot remanufacturing not a major setback for Intuitive
  • InspireMD wins CE Mark approval for CGuard Prime
  • Philips reports first cases for VeriSight Pro 3D ICE catheter in Europe
  • Ceryx Medical raises $15M to support bioelectronic pacemaker

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