The US FDA has issued draft guidance to help manufacturers substantiate the credibility of computational modeling and simulation used in submitting their medical devices to the agency for premarket approval. The agency says deficiencies in analytical methods for evaluating CM&S hampers its use in supporting regulatory submissions.
Medical device manufacturers often rely on computational modeling and simulation (CM&S) when designing new products. CM&S technology allows engineers and designers to conduct countless simulated experiments on virtual subjects.
During these experiments, numerous variables can be introduced into a programmed computation, then adjusted to observe various outcomes. These simulations...
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Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.
A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.
The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.
Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.
Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.
IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.
