• 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
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates

SynCardia

FDA: Select recall of Syncardia Freedom driver is Class 1

September 18, 2015 By Fink Densford

The FDA today said its recall of a select number of SynCardia Systems Total Artificial Heart Freedom driver is Class I. A Class I recall is the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” […]

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Recalls, Structural Heart Tagged With: SynCardia

SynCardia sets terms for $28m IPO

September 16, 2015 By Brad Perriello

SynCardia Systems today set the terms for its pending initial public offering, saying it plans to float 2.5 million shares at $10 to $12 apiece. That works out to a range of $25 million to $30 million, $27.5 million at the midpoint. Tucson-based SynCardia estimated that the IPO could raise as much as $40 million when […]

Filed Under: Initial Public Offering (IPO), Structural Heart Tagged With: SynCardia

Artificial heart maker Syncardia preps $40m IPO

August 18, 2015 By Brad Perriello

SynCardia Systems yesterday registered for an initial public offering worth up to $40 million, making it the 2nd medical device company in as many weeks to file for an IPO. SynCardia, which makes an artificial heart system designed to replace the functions of both the left and right ventricles and all 4 heart valves, said it plans to […]

Filed Under: Funding Roundup, Initial Public Offering (IPO), Structural Heart Tagged With: SynCardia

SynCardia warns on artificial heart driver

June 17, 2015 By Fink Densford

SynCardia Systems sent a letter to surgeons yesterday warning them about issues with a component of its artificial heart in patients who received pre-implant circulatory rescue interventions. The letter concerns Syncardia’s Total Artificial Heart Companion 2 Driver system. SynCardia won FDA approval for the C2 system in 2012 as a smaller replacement for the CSS console, which won […]

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Implants, Structural Heart Tagged With: FDA, SynCardia, Warning Letter

FDA OKs SynCardia trial for bridge-to-transplant indication

March 31, 2015 By Brad Perriello Leave a Comment

FDA OKs SynCardia trial for bridge-to-transplant indication

SynCardia Systems said today that it won FDA approval for a clinical trial of its artificial heart as a bridge to transplant for patients with heart failure.

Filed Under: Food & Drug Administration (FDA), News Well, Structural Heart Tagged With: Clinical Trials, SynCardia

Boston Scientific taps ex-Covidien CFO Dockendorff, Hologic CEO MacMillan for board | Personnel Moves

March 4, 2015 By Brad Perriello Leave a Comment

Boston Scientific taps ex-Covidien CEO Dockendorff, Hologic CEO MacMillan for board | Personnel Moves

Filed Under: News Well Tagged With: Alphabet (Google), Biolase, Biomet, Boston Scientific, Breg Inc., Covidien, HeartFlow, Hologic, Laurimed, Penumbra Inc., Personnel Moves, SynCardia, TearScience

Amniox Medical taps ex-Smith & Nephew honcho Dugan for CEO | Personnel Moves

January 14, 2015 By Brad Perriello Leave a Comment

Amniox Medical taps ex-Smith & Nephew exec Dugan for CEO | Personnel Moves

Filed Under: News Well Tagged With: Amniox Medical, Arrhythmia Research Technology Inc., depuysynthes, Echo Therapeutics Inc., Johnson and Johnson, Nuvasive, OMNIlife Science Inc., Personnel Moves, Pro-Dex Inc., Senseonics, Smith & Nephew, SynCardia, Tissue Regeneration Systems, Unilife Corp.

Press Release: FDA approves the Syncardia total artificial heart with Synhall valves

August 6, 2014 By MassDevice Leave a Comment

Press Release: FDA approves the Syncardia total artificial heart with Synhall valves

Filed Under: Pre-Market Approval (PMA), Regulatory/Compliance, Structural Heart Tagged With: Press Release, SynCardia

SynCardia lands key FDA win for its Total Artificial Heart

August 6, 2014 By Arezu Sarvestani Leave a Comment

Syncardia lands key FDA win for its Total Artificial Heart

Arizona-based SynCardia Systems announced this week that it won FDA approval for its SynHall valves, which the company called "the last key component to manufacture the Total Artificial Heart."

Filed Under: News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Structural Heart Tagged With: SynCardia

Press Release: FDA approves the freedom portable driver that powers the SynCardia total artificial heart

July 17, 2014 By MassDevice Leave a Comment

Press Release: FDA approves the freedom portable driver that powers the SynCardia total artificial heart

Filed Under: News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Structural Heart Tagged With: Press Release, SynCardia

FDA win lets SynCardia artificial heart patients out of the hospital

July 17, 2014 By Arezu Sarvestani Leave a Comment

FDA win lets SynCardia artificial heart patients out of the hospital

Artificial heart maker SynCardia announced this week that it won FDA approval for its Freedom driver, a portable power driver that allows patients to take their artificial heart systems out of the hospital.

Filed Under: News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Structural Heart Tagged With: SynCardia

  • « Go to Previous Page
  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Go to Next Page »

Primary Sidebar

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.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · 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