• 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
Home » Regulatory roundup: St. Jude Medical wins Australian, Malaysian approvals

Regulatory roundup: St. Jude Medical wins Australian, Malaysian approvals

January 27, 2011 By MassDevice staff

Clearances roundup

Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:

  • St. Jude Medical wins Australian, Malaysian approvals
    St. Jude Medical Inc. (NYSE:STJ) won a pair of approvals from international regulatory agencies. The company’s new manufacturing facility in Penang Island, Malaysia, won European CE Mark approval for production of pacemakers and leads, with the first product already en route to a distribution center in Veddesta, Sweden. St. Jude also pulled down a nod from the Australian Therapeutic Goods Administration for its Athena programmer for deep-brain stimulation.
    Read more
  • Corindus Vascular Robotics wins conditional FDA nod for pivotal trial
    Corindus Vascular Robotics won investigational device exemption approval from the Food & Drug Administration to evaluate for a 154-patient pivotal trial of its CorPath 200 System for percutaneous coronary interventions.
    Read more
  • On-X Life Technologies and Terumo’s Vascutek win FDA nod for aortic prosthesis/graft combo
    On-X Life Technologies Inc. and Terumo Corp.’s Vascutek subsidiary won FDA approval to market the On-X ascending aortic prosthesis with Vascutek’s Gelweave Valsalva graft.
    Read more
  • Biomerix wins CE Mark for Revive soft tissue repair mesh
    Biomerix Corp. received CE Mark approval for its Revive soft tissue repair mesh. The product won 510(k) clearance from the FDA in January 2009.
    Read more
  • Small Bone Innovations wins 510(k) for rHead extended stem
    Small Bone Innovations Inc. received 510(k) pre-market clearance from the FDA for its rHead extended stem for elbow procedures.
    Read more
  • Cardiac Science wins U.S. military certification
    Cardiac Science Corp. won Airworthiness Release from the U.S. Army’s Research, Development, and Engineering Command for its Powerheart AED G3 Pro automated external defibrillator.
    Read more
  • LDR files PMA for Mobi-C artificial cervical disc
    LDR announced the Jan. 14 submission of its single-level Mobi-C cervical artificial disc pre-market approval application to the FDA.
    Read more
  • Spectranetics wins FDA approval for manufacturing site change
    Spectranetics Corp. (NSDQ:SPNC) announced that the FDA approved its pre-market approval application supplement requesting a manufacturing site change for the CVX-300 laser system in Colorado Springs, Colo., as part of a broader plan to consolidate all product manufacturing into a single facility. Employees involved in the manufacturing of laser systems will move to the new manufacturing site, also in Colorado Springs, where the company has its headquarters.
    Read more
  • Extension Inc. files for FDA clearance and new device classification
    Extension Inc. announced the submission of its HealthAlert for Nurses solution to the FDA for product clearance, seeking a new device classification because there are no equivalent, predicate devices. The software delivers critical alerts to a Cisco IP handset or other mobile device.
    Read more
  • IVAX Diagnostics wins FDA clearance for Mago 4S assay
    IVAX Diagnostics Inc. (NYSE:IVD) received 510(k) clearance for its Mago 4S ELISA and immunofluorescence assay system for autoimmune and infectious disease testing.
    Read more

Filed Under: Diagnostics, News Well Tagged With: Corindus Vascular Robotics, Gift Bans, stjudemedical

In case you missed it

  • How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
  • Zimmer Biomet appoints new chief accounting officer
  • Cook Medical makes next-gen in vitro fertilization incubator available in U.S., Canada
  • Boston Scientific co-founder Peter Nicholas is dead at 80
  • How Boston Scientific uses clinical feedback to advance innovation
  • How Stryker includes users for product design in the digital age
  • DermaSensor wins MedTech Innovator Mid-Stage Companies Pitch Event
  • FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
  • Medtronic completes Intersect ENT acquisition
  • Steris rises on Street-beating Q4, sets fiscal 2023 guidance
  • Medtronic must sell Intersect ENT subsidiary to satisfy FTC concerns
  • Abbott partners with Women as One to help more underrepresented clinicians lead trials
  • Lucira Health asks FDA for EUA on molecular at-home COVID/flu test
  • Device commercialization platform AcuityMD raises $31M Series A to fund R&D engineer hiring
  • Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes
  • GE Healthcare to invest $50M in Pulsenmore to enter homecare segment
  • BD launches automated infectious disease diagnostic platform in the U.S.

RSS From Medical Design & Outsourcing

  • How Stryker includes users for product design in the digital age
    Medical device developers and manufacturers like Stryker (NYSE:SYK) are changing how they approach design as digital technology becomes more crucial. Four Stryker executives shared how the Kalamazoo, Michigan–based orthopedic device giant is thinking differently about medical product development and how health care providers and patients will ultimately use them. The DeviceTalks Boston panel of Stryker… […]
  • DermaSensor wins MedTech Innovator Mid-Stage Companies Pitch Event
    DermaSensor Inc. — the creator of a handheld, point-and-click device to quickly assess skin lesions for cancer risk — is the winner of the MedTech Innovator Mid-Stage Companies Pitch Event.  The Miami-based mid-stage company beat out 1,000 applicants, more than 20 of which competed on-site May 10–11, 2022 at DeviceTalks Boston. DermaSensor walked away with… […]
  • Steris rises on Street-beating Q4, sets fiscal 2023 guidance
    Steris (NYSE:STE) shares ticked up today on fourth-quarter financial results that came in just ahead of the consensus forecast. The infection prevention technology company — headquartered in Dublin, Ireland, and run operationally out of Mentor, Ohio — posted profits of $52.3 million, or 52¢ per share, on sales of $1.2 billion for the three months… […]
  • Lucira Health asks FDA for EUA on molecular at-home COVID/flu test
    Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test. Emeryville, California–based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a… […]
  • Device commercialization platform AcuityMD raises $31M Series A to fund R&D engineer hiring
    AcuityMD said today it has raised $31 million in Series A funding for its medical device commercialization platform. “With our new funding, we plan to double down on R&D by growing our engineering team from 15 to over 40 over the next year,” AcuityMD co-founder and CEO Michael Monovoukas said in a blog post. “We’ll… […]
  • Rockley Photonics announces $81.5M private placement
    Rockley Photonics (NYSE:RKLY) announced today that it entered into agreements for an $81.5 million private placement. Participating investors agreed to purchase $81.5 million in convertible senior secured notes (due 2026) and warrants to purchase 26.5 million Rockley ordinary shares at an exercise price of $5 per share, subject to certain anti-dilution adjustments. Warrants purchased in… […]
  • Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’
    The first day of DeviceTalks Boston closed with a panel of Stryker (NYSE:SYK) executives discussing new tools, technologies and strategies in medtech. Digital VP Tracy Robertson, Digital, Robotics, and Enabling Technologies President Robert Cohen and Surgical Technologies VP of Digital Innovation Siddarth Satish offered their thoughts on industry trends in healthcare and at the Kalamazoo,… […]
  • Medtronic’s VC leader discusses risk, returns, strategy and an ‘ugly truth’
    A panel of medtech investors convened today for DeviceTalks Boston included David Neustaedter, VP of venture capital at Medtronic (NYSE: MDT). He’s spent 14 years in the role, including as director of venture capital at Covidien before Medtronic acquired the company. (Read more in his DeviceTalks speaker bio.) Medtronic has more than $500 million in… […]
  • Here’s where Harvard’s engineering dean sees medtech research going
    Surgical robotics, artificial intelligence, and combatting climate change are but some of the priorities that have Harvard’s engineering school dean excited. Speaking today at DeviceTalks Boston, Frank J. Doyle III described the Harvard John A. Paulson School of Engineering and Applied Sciences as a “well-kept secret” historically. But Harvard engineering is staking out a strong position when it… […]
  • gBETA Medtech accelerator picks its next startups
    The gBETA Medtech virtual accelerator today named the five startups that will participate in the spring program leading up to the June 21 showcase day. The five startups for the spring 2022 cohort are: Mother of Fact: This mobile app for moms with babies offers nutrition tracking, preventative monitoring and daily coaching from licensed dietitians… […]
  • FDA warns of potential toxic risk from Fresenius hemodialysis machines
    The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines. The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K. The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) — are in the… […]

Leave a Reply

You must be logged in to post a comment.

Primary Sidebar

DeviceTalks Weekly

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
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