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.
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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.
Following US FDA's final guidance on Medical Device Development Tools last year, the agency announced the first such tool has been qualified and that stakeholders should expect a slew of MDDTs to be approved in the next few months, including ones that apply to wearable medical monitoring devices.
Three years in the making, FDA has released a final guidance for medical device development tools that would allow developers to qualify their MDDTs and give medical device manufactures access to new tools that could help them prove safety and effectiveness of their products sooner.