Panel Back On Track For TransMedics’ Heart Device After Missing A Few Beats
The US FDA will host an advisory committee webcast to discuss approval of the company’s new heart transplant device a year after it was originally planned.
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The company said the postponement will give the US FDA additional time to review trial data.
The FDA says it is looking to webcast the upcoming 7 April MDUFA user fee public meeting, which is slated to be one of the most important agency meetings of the year. The decision comes in light of difficulties holding in-person meetings as the US grapples with the ongoing coronavirus crisis.
Digital Health Roundup, March 2021: Record-Breaking Funding; Exec Chats With Medtronic, Edwards LifeSciences
In this new roundup feature focusing on the most notable developments in digital health, we pick the key news to date.