MolecuLightDX gets MDDT status

FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care

January 29, 2026
9:15 pm

PITTSBURGH, Jan. 29, 2026 /PRNewswire/ -- MolecuLight today announced that its MolecuLightDX® wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The FDA's MDDT program qualifies select, scientifically validated tools for use in medical device development and evaluation, enabling sponsors to generate reliable, FDA accepted data in clinical investigations.

With MDDT qualification, the MolecuLightDX quantitative wound measurement function is validated for regulatory use as a response biomarker, supporting objective evaluation of treatment effectiveness and data generation that may be used in FDA clearance and approval decisions for new wound products. Since the program began in 2017, MDDT qualification has been granted to only 20 tools, including MolecuLightDX®.

MolecuLightDX is the only wound care device that is both FDA Class II cleared for clinical use and FDA qualified as an MDDT, providing accurate, non-contact, and reproducible wound measurement images and data suitable for clinical trial endpoints across a variety of wound types.

FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care

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