Munich -- SurgicEye has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its declipseSPECT viewer, a solution for 3D navigated radio-guided surgery. Developed in cooperation with leading surgical oncologists, it will enable healthcare professionals to increase the efficiency of surgery with marked tumor structures, providing 3D imaging and navigation in the operating room.
declipseSPECT viewer is an extension of the Confident Surgery Suite 300 for 3D radioguided surgery providing surgical oncologists an intuitive guidance and navigation solution to resect radioactive labeled structures. Features include loading and in-situ visualization of preoperative SPECT/CT and PET/CT image data and a co-registered overlay on the patient.
Prior to its clearance, the declipseSPECT viewer has been evaluated extensively in topranked German and European reference centers for sentinel lymph node biopsy in head and neck cancer, melanoma, primary breast tumors and pelvic malignancies, in combination with laparoscopic surgery.

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The clearance also includes the compatibility with the Navigator gamma probe system of the Watertown, MA based Dynasil Products. Dr. Joerg Traub, CEO SurgicEye says: "with the integration of Dynasil's Navigator we have a strong alliance to provide the best solution for imaging and navigation in surgical oncology. The image quality of declipseSPECT with Dynasil's probes is superior to previous versions." Michael O'Neill, General Manager of Dynasil Products, adds: "the declipseSPECT extension combined with our gamma probe generates a 3D image and overlay onto the patient's anatomy. This smart extension may lead to less invasive surgeries. We are looking forward to a strong partnership in technology and clinical projects."
SurgicEye will present the declipseSPECT Viewer and the integration with Dynasil's Navigator at the Annual Meeting of the Society of Surgical Oncology (SSO) at March 06-09 in National Harbor, MD together with their US partner Dilon Diagnostics. Dilon Diagnostics, the leading company in Molecular Breast Imaging, is the exclusive U.S. distributor of declipseSPECT.
About SurgicEye GmbH
SurgicEye GmbH is a pioneer in intra-operative 3-D imaging for surgical navigation. The company develops breakthrough tools in the fight against cancer. The declipseSPECT from SurgicEye is the world's first FDA and CE certified product for intra-operative three dimensional visualization of radio labeled tissues and allows the detection, localization and guided biopsy of sentinel lymph nodes in breast cancer, melanoma and head & neck malignancies. Clinical investigations in other tumor surgery domains promise a wide application domain and huge potential for quality assurance during surgery. declipseSPECT enables surgical procedures to be more sensitive, more reliable and less invasive. SurgicEye's strong clinical expertise and partner institutions refine our products for seamless integration into existing workflows and demonstrate our efforts to engineer the best possible user experience.
About Dynasil
Dynasil Corporation of America (NASDAQ: DYSL) develops and manufactures detection and analysis technology, precision instruments and optical components for the homeland security, medical and industrial markets. Combining world-class technology with expertise in research and materials science, Dynasil is commercializing products including dual-mode radiation detection solutions for Homeland Security and commercial applications, probes for medical imaging and sensors for non-destructive testing. The Company is building a relationship with the Mayo Clinic to develop early-stage opportunities such as advanced biomedical technologies. Dynasil has an impressive and growing portfolio of issued and pending U.S. patents. The Company is based in Watertown, Massachusetts, with additional operations in Mass., Minn., NY, NJ and the United Kingdom. More information about the Company is
available at www.dynasil.com.