iThera in the news

CE Mark awarded to iThera Medical’s MSOT Acuity optoacoustic imaging system

May 31, 2019
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

Since its incorporation in 2010, iThera Medical develops and markets optoacoustic imaging systems for preclinical and clinical research. More recently, the company has started translating its technology for routine diagnostic clinical use across various types of diseases, including cancer, inflammatory, fibrotic, and cardiovascular diseases. Optoacoustic imaging utilizes the photoacoustic effect – the conversion of light energy into acoustic signals – to visualize and quantify optical contrast in deep tissue, at high spatial and temporal resolution.
Since its incorporation in 2010, iThera Medical develops and markets optoacoustic imaging systems for preclinical and clinical research. More recently, the company has started translating its technology for routine diagnostic clinical use across various types of diseases, including cancer, inflammatory, fibrotic, and cardiovascular diseases. Optoacoustic imaging utilizes the photoacoustic effect – the conversion of light energy into acoustic signals – to visualize and quantify optical contrast in deep tissue, at high spatial and temporal resolution.

For further information, please contact:
Christian Wiest
Phone: +49 (0) 89 700 7449-21
Email: christian.wiest@ithera-medical.com