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

MassDevice

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

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates

Penumbra Inc.

Penumbra lands Japanese OK for brain coil

September 11, 2012 By MassDevice staff Leave a Comment

Penumbra Inc.

Penumbra said it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Penumbra Coil 400 intracranial aneurysm device.

The Alameda, Calif.-based medical device company said it plans to launch the device immediately via an exclusive distribution agreement with Japan’s Medico’s Hirata.

Filed Under: Neurological, News Well Tagged With: Exports, Neurovascular repair, Penumbra Inc.

St. Jude gets Japanese go-ahead for smallest ICD and CRT in the industry

June 21, 2011 By MassDevice staff Leave a Comment

UnifyCRT

St. Jude Medical (NYSE:STJ) announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare for its Fortify implantable cardioverter defibrillator and Unify cardiac resynchronization therapy defibrillator, and the company launched the products in the Japanese market.

A ICD is an device that treats abnormally fast heart rhythms, and a CRT-D resynchronizes beating in the heart’s lower chambers, which often beat out of sync in heart failure patients.

Filed Under: Implants, News Well Tagged With: INVO Bioscience, Konica Minolta Opto Inc., Penumbra Inc., stjudemedical, X-spine Systems Inc.

Recall news: iCad pulls radiation shield for breast cancer

April 15, 2011 By MassDevice staff Leave a Comment

FDA

The FDA released a flurry of recalls for medical devices this week.

First, iCad Inc. (NSDQ:ICAD), formerly Xoft Inc., had to remove a radiation guard for breast cancer treatment, over reports that the device sheds tungsten particles.

The FDA issued the Class I recall for Sunnyvale, Calif.-based company’s Axxent FlexiShield Mini, Model F5300. The Food & Drug Administration issues Class I recalls when there is potential for serious injury or death from use of a particular device or product.

Filed Under: Food & Drug Administration (FDA), News Well, Recalls Tagged With: iCad Inc., Moog Inc, Penumbra Inc., Philips, Warning Letter

  • « Go to Previous Page
  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Go to page 4

Primary Sidebar

DeviceTalks Weekly

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

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.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

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

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · 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.

Advertise | Privacy Policy | RSS