SurgicEye receives FDA approval for declipseSPECT viewer

SurgicEye receives FDA approval for declipseSPECT viewer
15th February 2013 admin

declipseSPECT viewer is an extension of the Confident Surgery Suite 300 for 3D radio-guided 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 top-ranked 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.

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.

For further information please visit www.surgiceye.com.
SurgicEye GmbH
Friedenst. 18A
81671 Munich
Germany

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fon: +49 89 54 99 89 001