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

Newborn Screening Tests Among FDA Classifications

 
• By 

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

 

Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

More from Policy & Regulation