OEM News, Regulatory

FDA Clears SamanTree Medical’s Histolog Scanner

The scanner is a confocal microscopy device intended for imaging the surface of excised human tissue specimens to visualize morphological microstructures.

By: Michael Barbella

Managing Editor

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SamanTree Medical has gained U.S. Food and Drug Administration (FDA) 510(k) clearance of its Histolog Scanner for imaging internal tissue microstructure including, but not limited to, the identification of cells, vessels, and their organization or architecture.

“We are thrilled to introduce the Histolog Scanner to the U.S. market,” SamanTree Medical Chairman Dr. Charles Carignan said. “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.”

The Swiss made device is designed to provide real-time, high-resolution 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 clinicians to immediately take images of resected tissues. This advancement aims to help physicians improve their efficiency.
 
“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,” stated Prof. Dr. Alex Mottrie, head of the Urological Department OLV Hospital, Aalst, Belgium and CEO of ORSI Academy in Ghent, Belgium. 
 
“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,” added Prof. Dr. Ari D. Brooks, director of Endocrine and Oncologic Surgery at Pennsylvania Hospital in Philadelphia.

“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,” noted Prof Dr. Douglas Scherr, clinical director of Urologic Oncology at the Weill Medical College of Cornell University. “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.”
 
SamanTree Medical is committed to enhancing clinical outcomes through the development of advanced imaging technologies. The Histolog Scanner offers realtime, high-resolution imaging of excised tissue surfaces, providing physicians with this information for immediate assessments. 

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