FDA Gives Sponsors A New Tool To Prove MRI-Compatibility
The US FDA has qualified a new modeling tool that could give sponsors more assurance that their products meet the agency’s expectations for MRI-compatibility.
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The head of US FDA's device center says there are a substantial number of medical device development tools under review by the agency that could help speed up data collection for product approvals and clearances, but they are not likely to be OK'd by the agency until next year.
On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporters Danny Al-Faruque and Sue Darcey about specific pieces of legislation that are expected to pass through the US Congress in the new year and how they’ll impact the medical device sector.
Though it didn’t even get to committee, a bill to make it easier for tech companies to patent software – including medical software – has a good chance of getting passed in Congress this year, bill proponents and legal experts say.