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Medical Device Development Tools (MDDT)




FDA has qualified the first digital biomarker for use in clinical trials! 🚨 🚨

Here are the details:

🍏 The Apple AFib History Feature was qualified through FDA's Medical Device Development Tools (MDDT) program

⌚ This digital biomarker evaluates estimates of AFib Burden

🔬 It is qualified as a secondary efficacy endpoint in clinical trials of cardiac ablation devices

So what does this mean?!

The MDDT Program has emerged as the dark horse for the long-awaited big win for digital clinical measures in clinical trials.

The FDA's acceptance of digitally measured moderate to vigorous physical activity (MVPA) as the primary endpoint in Bellerophon Therapeutics' Phase 3 clinical trial of INOpulse® for treatment of Fibrotic Interstitial Lung Disease signaled regulatory embrace of high-value, high-quality digital endpoints. But when that therapy didn't perform, the regulatory breakthrough was overshadowed.

Today is a straight-up win for all of us that believe in the promise of sensor-based digital health technologies (sDHTs) to transform the way we develop new medical products to better serve the patients our industry exists to serve. Onwards! 🚀

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