SamanTree Medical Achieves FDA Clearance for Histolog® Scanner, Ushering in a New Era of Tissue Imaging in the U.S.
Liège, Belgium and Lausanne, Switzerland – September 13th, 2024 – SamanTree Medical, a leader in innovative surgical imaging solutions, today announced that it has received FDA 510(k) clearance of its Histolog® Scanner for imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture. This groundbreaking Swiss made device is designed to provide real-time, highresolution imaging of fresh tissue surfaces, offering surgeons and pathologists this information for excised tissue.
The Histolog® Scanner enables real-time, ultra-fast confocal microscopy, allowing for the immediate imaging of resected tissues. This advancement aims to enable physicians to improve their efficiency.
“We are thrilled to introduce the Histolog® Scanner to the U.S. market,” said Dr. Charles Carignan, Executive Chairman of SamanTree Medical. “This FDA clearance is a significant milestone for the company. The ability of the Histolog® Scanner to produce real-time imaging of the internal microstructure of tissues provides surgeons and pathologists with immediate, actionable information.”
Prof. Dr. Alex Mottrie, Head of the Urological Department OLV Hospital, Aalst, Belgium and CEO of ORSI Academy, Ghent, Belgium, commented on the impact of this new technology: “The Histolog® Scanner represents cutting-edge technology in imaging of freshly excised tissue. Its ability to provide high-resolution, real-time images allows us to make more informed decisions.”
Prof. Dr. Ari D. Brooks, Director of Endocrine and Oncologic Surgery, Pennsylvania Hospital, Philadelphia, PA said “The Histolog technology has the potential to significantly reduce the cost, resources and delays associated with the current lack of real-time high-resolution imaging”. Prof Dr. Douglas Scherr, Clinical Director of Urologic Oncology at the Weill Medical College of Cornell University said “Providing imaging data at this resolution has the potential to aid in patient care. In our practice and across Urology, as a field, we are facing limitations in the ability to provide timely decisions to our patients. We will count on the Histolog Scanner to provide us with the ability to image the tissues’ microstructures in real-time and to enable us to make immediate decisions.”
The FDA clearance of the Histolog® Scanner marks a crucial moment in SamanTree Medical’s mission to expand its innovative imaging solutions globally. With this clearance, SamanTree is set to accelerate its U.S. market entry, ensuring that more healthcare providers can leverage the benefits of this cutting-edge technology.
About SamanTree Medical
SamanTree Medical is committed to enhancing clinical outcomes through the development of advanced imaging technologies. The Histolog® Scanner, now FDA-cleared, offers realtime, high-resolution imaging of excised tissue surfaces, providing physicians with this information for immediate assessments. Following the initialcommercialization in Europe, the Histolog® Scanner is poised to make a significant impact in the U.S. healthcare market.
Contact Information
Olivier Delporte
CEO, SamanTree Medical
info@samantree.com
For more information, visit www.samantree.com