OCS Liver System Moves One Step Closer To Approval After Panel Recommendation

A panel of medical experts recommended that the US Food and Drug Administration grant premarket approval to a system designed to preserve and monitor livers destined for transplant recipients.

HUMAN ORGAN DELIVERY.
• Source: Alamy

The FDA’s gastroenterology and urology devices advisory committee recommend the agency approve the TransMedics Organ Care System (OCS) Liver System premarket approval.

Despite questions the FDA raised regarding data collected during the system’s clinical trials the 14-member panel voted unanimously on the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approvals

More from Policy & Regulation

Experts Call For Database Of Medical Device Labels

 
• By 

A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.

EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 

EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.