FDA panel recommends approval for TransMedics lung transplant device
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 MassDevice.com via email.
TransMedics did not respond to a request for comment.
A previously scheduled advisory panel hearing for another TransMedics device, the OCS Heart system, was cancelled by the FDA in November 2015. ...
Source: Mass Device - May 18, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Gastroenterology & Urology Devices panel Organ Transplant Transmedics Inc. Source Type: news
Tiny bubbles help heal broken bones, in pigs
Researchers have developed a much needed alternative to bone grafts that could help alleviate the long-term hospitalization, disability, and considerable costs to the health system associated with non-healing fractures. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 17, 2017 Category: Science Source Type: news
Gene Therapy Might Mend Badly Broken Bones
Animal experiments suggest this may be a potential alternative to bone grafts, researchers say (Source: WebMD Health)
Source: WebMD Health - May 17, 2017 Category: Consumer Health News Source Type: news
Gene Therapy Might Someday Mend Badly Broken Bones
Animal experiments suggest this may be a potential alternative to bone grafts, researchers say Source: HealthDay Related MedlinePlus Pages: Bone Grafts, Genes and Gene Therapy, Stem Cells (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - May 17, 2017 Category: Consumer Health News Source Type: news
7 medtech stories we missed this week: April 21, 2017
[Image from unsplash.com]From new and renewed partnerships to FDA approvals, here are 7 medtech stories we missed this week but thought were still worth mentioning.
1. Life Spine receives FDA clearance for cervical spacer system
Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer System. The system uses Life Spine’s titanium surface technology, Osseo-Loc, that helps with potential bone growth. Plateau-C Ti also has additional graft windows to help with visibility in-situ and bone graft containment. It entered full-market release on April 3 this...
Source: Mass Device - April 21, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: 510(k) Clinical Trials Food & Drug Administration (FDA) News Well Pre-Market Approval (PMA) Regulatory/Compliance Clearflow Condor Getinge Life Spine Lifetrack Medical Mayo Clinic Monitored Therapeutics Owlstone Medical Physio- Source Type: news
