Interview: US FDA's Bakul Patel On 'Pre-Cert'-Selected Software Companies
Apple and FitBit joined Johnson & Johnson and Roche, along with five other tech firms and health startups on the list those selected for US FDA's new "Pre-Cert" pilot program for digital health. Medtech Insight caught up with FDA digital-health expert Bakul Patel for a chat on Sept. 26 at AdvaMed's Medtech Conference where the participants were announced.
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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.