Shuren: More Than A Dozen MDDTs Under Review, But No More This Year
The head of US FDA's device center says there are a substantial number of medical device development tools under review by the agency that could help speed up data collection for product approvals and clearances, but they are not likely to be OK'd by the agency until next year.
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The sixth Medical Device Development Tool qualified by the US FDA allows makers of artificial pancreases to provide data on psychosocial effects and quality-of-life changes of patients using their product. Ultimately, it may be the key to whether the agency allows the product on the market or not.
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.
No Brainer: US FDA Greenlights First Biomarker Software As Medical Device Development Tool For Brain Injury
Developers of medical devices intended to treat traumatic brain injuries may want to consider using an imaging software developed to detect contusions. The product is the third Medical Device Development Tool qualified by US FDA, which means the agency trusts it to output accurate data supporting clinical trials.