MolecuLightDX Wound Measurement Deemed a Medical Device Development Tool by FDA

MolecuLight’s wound measurement solution, MolecuLightDX, has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The 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 the 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.

“The FDA’s qualification of MolecuLightDX as an MDDT reflects the strength of our clinical evidence and the agency’s confidence in the accuracy and reproducibility of our wound measurement technology,” MolecuLight CEO Anil Amlani stated. “This designation enables researchers and sponsors to use MolecuLightDX as a standardized, trusted measurement tool in wound healing studies, accelerating innovation and improving patient outcomes.”

MolecuLightDX is class II FDA-cleared medical device for the real-time detection and visualization of elevated bacterial loads (>10⁴ CFU/g) in wounds using its proprietary fluorescence imaging technology. Its performance is supported by the largest clinical validation study conducted in wound imaging, demonstrating consistent results across wound types, skin tones, and patient populations.  

MolecuLight is a privately held medical imaging company with a global footprint, dedicated to manufacturing and commercializing the MolecuLight i:X and DX wound imaging devices. Both FDA-cleared Class II point-of-care systems provide real-time detection of elevated bacterial burden and accurate digital wound measurement. The MolecuLightDX additionally offers thermal imaging for comprehensive wound assessment. The technologies’ effectiveness and clinical utility are supported by more than 100 peer-reviewed publications.