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With the EU Medical Device Regulations just over one year away, this latest revision aims to help medical device manufacturers meet the regulation’s General Safety and Performance Requirements.
FDA urges collaboration, but healthcare system limitations and FDA guidance prompt medical devices to be secure by design to ensure patient safety.
A medtech analyst says recent developments have created more uncertainty about paclitaxel-coated balloons and stents.
Different materials, different finishes, and even different economics should be considered for home-use medical devices, say experts from a polymer manufacturer.
The new diagnostic assay format could provide a means of performing low-cost tests for particular strains of flu at the point of care, but there are challenges to address.
Yann Fleureau, co-founder and CEO of Cardiologs, weighs in on why 2019 will be known as the year of validation for artificial intelligence.
A study looked at surgical work flow to better understand how Unique Device Identifiers are recorded.
These were some of the most thought-provoking comments MD+DI editors heard from industry experts who spoke at MD&M West 2019.
Advances in medtech prototyping are driving new manufacturing capabilities. An on-demand medtech contract manufacturer offers one perspective.
CEO John Onopchenko said the company is shifting from a defensive position to an offensive position and expects to return to growth in the second half of the year.