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Latest From Ferdous Al-Faruque
Philips CEO Frans von Houten says the future of health care is in AI platforms that will transform how effectively and efficiently patients are treated. He predicts the technology will be so ubiquitous that users will not even realize they are interacting with the technology.
Device Week, April 17, 2019 – Safety Under Spotlight After Mesh Pulled From US Market, Pediatric Air Tubes Run Short
In this week's Medtech Insight podcast, Shawn M. Schmitt explains why the FDA ordered transvaginal mesh products removed from the US market, and Ferdous Al-Faruque highlights a growing device-shortage issue linked to problems at two US sterilization facilities.
After an Illinois sterilization facility was shut down earlier this year, the US FDA says it has resulted in a temporary shortage of Bivona emergency breathing devices for children. The agency is working with the manufacturer, Smiths Medical, to figure out a solution quickly, but won’t have new inventory on the market for at least another week.
If You Build It, They Will Come: FDAer Says Pre-Cert Program Getting Global Attention, AI Paper Just the Start
International regulators are interested in seeing how they too can apply the US FDA’s precertification program, which is currently in the pilot stage. In an exclusive interview with Medtech Insight, the agency’s top digital health officer, Bakul Patel, talks about global curiosity about the program that could allow companies to get certain medical software on the market based on trust. Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.
In this Medtech Insight podcast from the 2019 World Medical Innovation Forum in Boston, Bakul Patel – the US FDA's top digital health officer – talks about the agency's precertification program and its plans for artificial intelligence.