The Munich-based company was today awarded the CE Mark for its MSOT Acuity imaging system, indicating conformity with health, safety and environmental protection for medical devices sold in Europe. This non-invasive, novel technology allows radiation- and contrast-agent-free imaging of soft tissue. It combines laser excitation and ultrasound detection for the analysis of hemoglobin, lipids, collagen and other chromophores in tissue.
“We are excited about the CE certification for the MSOT Acuity system. It brings us one step closer to bringing a new, non-invasive and fast diagnostic tool to doctors and patients”, said Christian Wiest, CEO and co-founder of iThera Medical.
MSOT (multispectral optoacoustic tomography), a technology initially developed at the Institute of Biological and Medical Imaging of the Helmholtz Center Munich, is based on the photoacoustic effect which describes how absorbed light results in the emission of acoustic signals; essentially, ‘light in, sound out’. MSOT has the unique capability of visualizing optical contrast at high resolution in deep tissue and in real time. By tuning the wavelength of the excitation laser, it can also discriminate chromophores that have a characteristic spectrum in the near-infrared.
Initial research suggests that MSOT imaging could provide clinical value for a wide range of diagnostic imaging applications. Exploratory clinical trials that have already been successfully completed cover the fields of inflammatory bowel disease, various soft tissue cancers, systemic sclerosis, muscular dystrophy, and cardiovascular diseases.
With the receipt of the CE mark, clinical researchers can now more readily explore where MSOT can provide clinical value by improving the diagnostic accuracy or reducing patient burden and risk of complications. iThera Medical invites clinical researchers to contribute to the further success story of translating MSOT from preclinical research into clinical routine.
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