• 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 » Medtech makers warn on new EU rules | MassDevice.com On Call

Medtech makers warn on new EU rules | MassDevice.com On Call

April 1, 2014 By MassDevice Contributors Network

MassDevice.com On Call

MASSDEVICE ON CALL — Medical device makers that relocated to Europe to take advantage of its easier path to approval are worried about new European Union rules, the Financial Times reports.

Companies such as Middle Peak Medical, which is developing a mitral valve implant, moved some of their operations to the EU to escape the FDA’s more-stringent approval protocols. But the new EU rules could take a bite out of that advantage, they worry.

That’s because EU rules only require that a clinical trial prove a device is no worse than its comparator, while in the U.S. the trial must prove superiority.

"For very established treatments like heart valve treatment, that is very difficult. The U.S. has cut itself off from certain paths of innovation with this policy," Regina Hodits of Wellington Partners, which participated in Middle Peak’s Series A round last year, told the newspaper. "For that reason, it is difficult for medical device start-ups to finance through to market. It has become less interesting for U.S. [venture capital shops] to finance early start-ups."

"We’ve got a steady stream of U.S. companies knocking on our door. Middle Peak Medical was the first one of them. We only do them if we feel the major part of the business will be in Europe like clinical development and the first commercialization," Hodits said.

Last October the European Parliament voted to strengthen the rules by authorizing unannounced inspections and more stringent monitoring of the "notified bodies" that govern medical device regulation there.

 Duo charged with stealing patient data from Queens hospital

A pair of workers at Jamaica Hospital Medical Center in New York City were charged with stealing patients’ emergency room data and passing it along to rehab centers and personal injury lawyers, according to Queens district attorney Richard Brown.

Read more

 Self-flushing urinary catheter prevents infections
Researchers at Duke University created a urinary catheter that can be cleansed of biofilms by using physical forces to dislodge bacterial biofilms, which are then flushed out along with the urine.
Read more

 Healthcare reform boosted ER use in Mass.

The healthcare reform law enacted in Massachusetts in 2006 was linked to a small but consistent increase in emergency department use, according to a study in the Annals of Emergency Medicine.
Read more

Filed Under: News Well Tagged With: Middle Peak Medical, On Call, Wellington Partners

More recent news

  • Aurora Spine begins first procedures with Aero lumbar fusion system
  • Caranx Medical surgical robot TaviPilot AI software wins FDA clearance
  • InspireMD launches carotid stent in U.S. after FDA approval
  • Neuros Medical raises $56M Series D to support nerve stim tech
  • CorWave reports first-in-human LVAD implant

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