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Latest From Ferdous Al-Faruque
The US FDA has finalized a new rule that updates a slew of agency regulations so sponsors no longer have to submit multiple paper copies of premarket submission applications. The agency says the rule could save companies millions of dollars.
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.
The US agency will host a two-day meeting to discuss the evolution of artificial intelligence technology used to analyze radiological images when diagnosing patients and in advising radiologists to take optimal pictures. The takeaways from the meeting will be used by the FDA to help it develop its thinking on how to regulate such technology.
Over the past year a number of medical device sterilization facilities that use ethylene oxide, or EtO, have shut down as state regulators have raised concerns about their potential environmental impact. On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporter Danny Al-Faruque about what’s happened to date, as well as where this EtO issue is headed in the future.
Tech Companies Grappling With A Brave New World Of Regulations While Developing Digital-Health Products
Software firms interested in the digital-health arena are engaging US FDA more and bolstering their regulatory credentials to navigate an unfamiliar regulatory landscape, industry experts tell Medtech Insight.
A Race Against Time? One Man’s Search For Artificial Intelligence Medical Device Standards That Can Keep Up
Pat Baird – Philips Healthcare’s regulatory standards guru – says by the time artificial intelligence/machine learning standards are developed and recognized by regulators, they may already be out-of-date. To speed up the process, he’s taken it upon himself to aggregate the most critical standards to help industry and regulators alike develop guidelines on how such products should be developed and operate.