1. Medtech Insight
  2. >>Device Area
  3. >>Cardiology

TransMedics Faces 2nd Panel Date Postponement

Will the third time be the charm?

 
• By Elizabeth Orr

The company said the postponement will give the US FDA additional time to review trial data.

FDA Advisory Committee Feature image

TransMedics will need to wait a bit longer for its heart transplant device to be considered by a US Food and Drug Administration panel.

The Circulatory System Devices Panel virtual meeting on the TransMedics Organ Care System (OCS) Heart had been scheduled for 7...

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
Start Free Trial

Already a subscriber?

More from Cardiology

More from Device Area

SpotitEarly Sets Up US HQ, Launches Trials For Dog- And AI-Powered Early Cancer Detection Test

 
• By Marion Webb

Among early cancer screening tests, SpotitEarly stands out by combining dogs’ superior sense of smell with machine learning. SpotitEarly plans two US clinical trials for breast and lung cancer aiming to seek FDA clearance, but needs more funding to support clinical development and commercialization.

Additional Death And Injuries Added To 2024 Philips Ventilator Recall

 
• By Brian Bossetta

Philips Respironics has updated instructions for use for three ventilators that were included in a May 2024 recall. The company also added three potential injuries and one death to the original number.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.