• 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

Organ Transplant

FDA panel recommends approval for TransMedics lung transplant device

May 18, 2017 By Brad Perriello

An FDA advisory panel yesterday recommended that the federal safety watchdog approve a device made by TransMedics to keep donated lungs perfused during transport to transplantation procedures. The FDA’s Gastroenterology & Urology Devices panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, an FDA spokeswoman told […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Gastroenterology & Urology Devices panel, Organ Transplant, transmedics

TransMedics launches pivotal trial for OCS liver transplant system

February 23, 2016 By Brad Perriello

TransMedics said today that it launched a pivotal study of its OCS Liver device, which is designed to keep donated human liver warm and perfused until transplantation. Andover, Mass.-based TransMedics said the 1st liver transplantation using OCS Liver was performed at Mass. General Hospital by Dr. James Markmann, a lead investigator for the 300-patient OCS Liver […]

Filed Under: Clinical Trials, Surgical Tagged With: Organ Transplant, transmedics

TransMedics wins FDA panel date for organ preservation device

October 7, 2015 By Brad Perriello

The FDA plans to convene an advisory panel to review the pre-market approval bid for the organ preservation device made by TransMedics. The FDA’s Gastroenterology & Urology Devices panel is slated to meet Nov. 18 to discuss Andover, Mass.-based TransMedics’ PMA bid for its Organ Care System, which is designed to perfuse a donor heart with warm, oxygenated blood and monitor its status until […]

Filed Under: Cardiovascular, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Organ Transplant, transmedics

TransMedics raises $20m for ‘heart-in-a-box’

June 8, 2015 By Brad Perriello

TransMedics raised a $20 million funding round for its organ preservation and transportation device, according to a regulatory filing. Eleven unnamed investors participated in the round for Andover, Mass.-based TransMedics, according to the filing. The TransMedics organ care system is designed to perfuse the heart or other organs with warm, oxygenated blood, continuously monitoring their status until […]

Filed Under: Business/Financial News, Funding Roundup Tagged With: Organ Transplant

Doctors perform historic skull-and-scalp transplant surgery

June 5, 2015 By MassDevice

(Reuters) — A man whose cancer left him with severe damage to the top of the head received what his doctors in Houston describe as the 1st skull-and-scalp transplant, the MD Anderson Cancer Center said yesterday. James Boysen, a 55-year-old software developer from Austin, received the craniofacial tissue transplant at the same time as a […]

Filed Under: Surgical Tagged With: Organ Transplant

San Francisco hospital begins rare 6-way kidney transplant chain

March 6, 2015 By MassDevice Contributors Network Leave a Comment

San Francisco hospital begins rare 6-way kidney transplant chain

(Reuters) — Doctors at a San Francisco hospital began an unusual series of kidney transplants yesterday with 6 living donors providing organs to 6 patients in a chain that began with a woman described as an altruistic donor unrelated to any of the recipients.

Filed Under: News Well Tagged With: California Pacific Medical Center, Organ Transplant, Renal

TransMedics heart preservation system used in Aussie transplants

October 27, 2014 By Alexander Soule Leave a Comment

TransMedics heart preservation system used in Aussie transplants

Transmedics said surgeons in Australia used its organ care system to preserve and assess a trio of hearts from donors whose organs had stopped beating, before the hearts were successfully transplanted.

Filed Under: News Well Tagged With: Organ Transplant, transmedics

XVIVO Perfusion wins FDA approval for donor lung transport system

August 13, 2014 By Arezu Sarvestani Leave a Comment

XVIVO Perfusion wins FDA approval for donor lung transport system

The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.

Filed Under: News Well, Pre-Market Approval (PMA) Tagged With: Humanitarian Device Exemption (HDE), Organ Transplant, XVIVO Perfusion

Press Release: FDA approves donor lung preservation device that may result in more lung transplants

August 13, 2014 By MassDevice Contributors Network Leave a Comment

Press Release: FDA approves donor lung preservation device that may result in more lung transplants

Filed Under: News Well, Pre-Market Approval (PMA) Tagged With: Humanitarian Device Exemption (HDE), Organ Transplant, Press Release, XVIVO Perfusion

FDA sets a date to review XVIVO’s lung perfusion system

February 14, 2014 By Arezu Sarvestani Leave a Comment

FDA sets a date to review XVIVO's perfusion system

Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs.

XVIVO will meet on March 20 with the FDA’s Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Humanitarian Device Exemption (HDE), Organ Transplant, XVIVO Perfusion

Cali biotech promises a 3D-printed organ this year | MassDevice.com On Call

January 7, 2014 By Arezu Sarvestani Leave a Comment

MassDevice.com On Call

MASSDEVICE ON CALL — California biotech startup Organovo has its sights set high, promising to demonstrate the promise of 3D bio-printing technology by unveiling a human organ made of printed living cells by the end the year.

Organovo plans to begin organ-printing with the human liver, constructed by laying down layer after layer of human tissue to form a single organ. To do so, the company needs to develop a sort of vascular system to keep the organ fed with nutrients and oxygen, lest it wither on the printer.

Filed Under: Biotech, News Well Tagged With: On Call, Organ Transplant, Organovo

  • Page 1
  • Page 2
  • Page 3
  • Page 4
  • Go to Next Page »

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