FDA批准MolecuLightDX的伤口试验成像工具, 推动更快、更好的伤口护理创新。 FDA approves MolecuLightDX’s imaging tool for wound trials, boosting faster, better wound care innovation.

林业发展局已将MolecuLightDX的伤口成像技术定为医疗设备开发工具,允许在临床试验中使用该技术,以支持对新的伤口护理产品的批准。 The FDA has qualified MolecuLightDX’s wound imaging technology as a Medical Device Development Tool, allowing its use in clinical trials to support new wound care product approvals. 该工具使用荧光成像探测细菌水平并提供标准化测量,是林业发展局批准并符合《麦地那二类药物方案》资格的唯一伤口装置。 The tool, which uses fluorescence imaging to detect bacterial levels and provide standardized measurements, is the only wound device both FDA-cleared and qualified under the MDDT program. 这一指定突出了其科学有效性和可复制性,并辅以广泛的临床研究和同行审查研究,目的是加速创新,改善患者在创伤护理方面的结果。 This designation highlights its scientific validity and reproducibility, backed by extensive clinical research and peer-reviewed studies, and aims to speed up innovation and improve patient outcomes in wound care.