MolecuLight announced that its MolecuLightDX® wound measurement system has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). This program validates scientifically proven tools for use in medical device development, allowing sponsors to generate reliable, FDA-accepted data during clinical trials.
What This Means
- The MDDT designation confirms that MolecuLightDX can be used as a regulatory-grade response biomarker.
- Researchers can now use it to objectively measure treatment effectiveness in wound care studies.
- Only 20 tools have received MDDT qualification since the program began in 2017, highlighting the rarity and significance of this achievement.
MolecuLightDX: A Unique Wound Care Solution
- Dual recognition: It is the only device both FDA Class II cleared for clinical use and FDA-qualified as an MDDT.
- Non-contact and reproducible: Provides accurate wound measurement images suitable for clinical trial endpoints across a range of wound types.
- Proprietary fluorescence imaging: Detects elevated bacterial loads in real-time, supporting improved wound care decision-making.
- Clinical validation: Backed by the largest wound imaging clinical study, showing consistent performance across patient populations, wound types, and skin tones.
Executive Insight
Anil Amlani, CEO of MolecuLight, said:
“The FDA’s qualification of MolecuLightDX reflects the strength of our clinical evidence and the agency’s confidence in the accuracy of our technology. Researchers can now rely on MolecuLightDX as a standardized tool in wound healing studies, accelerating innovation and improving patient outcomes.”
Why Investors Should Take Note
- Regulatory milestone: MDDT qualification can accelerate adoption and clinical study use, potentially increasing market penetration.
- Market differentiation: MolecuLightDX is uniquely positioned among wound care devices, combining imaging, measurement, and bacterial detection.
- Scientific credibility: Supported by 100+ peer-reviewed publications, reinforcing adoption in hospitals and research institutions globally.
- Growth potential: As a validated tool for clinical trials, MolecuLightDX may expand partnerships with device manufacturers and wound care product developers.
Bottom line: MolecuLightDX’s dual FDA recognition strengthens its position as a leading wound care measurement platform and opens opportunities for broader clinical and commercial adoption.
