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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.

Painful Headache pain and pounding migraine concept as a human head made of cement being destroyed or renovated by a group of wrecking balls as a symbol for personal change as a 3D illustration. - Illustration
A new MDDT tool can be used to develop treatments and diagnostics for traumatic brain injury

It can be challenging for medical device sponsors to know what kind of data will be adequate for US FDA when they file pre-market applications – especially when there isn’t sufficient information to support the data. To help provide more clarity and reliability, FDA has been qualifying Medical Device Development Tools that sponsors can use when gathering data.

And because the tools are vetted by the agency, sponsors can be confident in

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