The Munich-based biomedical imaging company was awarded the CE Mark for its MSOT Acuity Echo imaging system, indicating conformity with health, safety and environmental protection for medical devices sold in Europe. Following the first CE mark for its optoacoustic imaging system MSOT Acuity in 2019, this newly CE-marked device now combines optoacoustic with ultrasound tomography.
“We are very excited about the CE certification of our MSOT Acuity Echo system. The integration of ultrasound imaging is key for clinical users of optoacoustics. With the imminent introduction of the strict MDR regulations adding complexity to the life of clinical researchers, users can now rely on a CE-marked device for their clinical trials”, said Christian Wiest, CEO and co-founder of iThera Medical.
MSOT (multispectral optoacoustic tomography) is based on the photoacoustic effect which describes the emission of acoustic signals following light absorption. MSOT has the unique capability to visualize optical contrast at high resolution, in deep tissue in real time. By tuning the wavelength of the excitation laser, it can discriminate tissue chromophores that have a characteristic spectrum in the near-infrared; particularly hemoglobin, lipids, collagen, and water.
In addition to the MSOT image, the MSOT Acuity Echo now features a real-time tomographic ultrasound image. The co-registration of these two imaging modes gives the clinician confidence to identify relevant anatomical structures based on the ultrasound image and then probe the tissue of interest for functional and molecular biomarkers using MSOT.
Initial research suggests that MSOT imaging could provide clinical value for a wide range of diagnostic imaging applications. Exploratory clinical trials have already been successfully completed in the fields of inflammation, cancer, fibrosis as well as cardiovascular and metabolic diseases. The first multi-center regulatory trial for a diagnostic application is ongoing for the indication of inflammatory bowel disease (IBD). With the receipt of the CE mark, clinical researchers can now readily explore the clinical value of MSOT, even following the imminent introduction of the new MDR (Medical Device Regulation).
ABOUT iTHERA MEDICAL
iThera Medical develops and markets biomedical imaging systems based on a novel technology called Multispectral Optoacoustic Tomography (MSOT). MSOT utilizes the photoacoustic effect – light energy absorbance resulting in acoustic signal emission – to visualize and quantify optical contrast in deep tissue, at high spatiotemporal resolution. MSOT allows the study of disease processes on a functional and molecular level. Recently, MSOT has been translated for clinical use and promises to become a valuable diagnostic tool for a variety of diseases. Find out more about iThera Medical at https://www.ithera-medical.com.
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The EUPHORIA Project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 830965. The material presented and views expressed here are the responsibility of the author(s) only. The EU Commission takes no responsibility for any use made of the information set out.