SamanTree Medical received FDA 510(k) clearance for its Histolog scanner for tissue imaging. Histolog enables imaging of the internal microstructure of tissues. That includes the identification of cells, vessels and their organization or architecture. The Switzerland-based company designed the device to deliver real-time, high-resolution imaging of fresh, excised tissue surfaces.
According to a news release, the SamanTree Histolog system enables real-time, ultra-fast confocal microscopy. This enables the immediate imaging of resected tissues, allowing physicians to improve their efficiency.
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Dr. Ari D. Brooks of Pennsylvania Hospital (Philadelphia) said the technology could potentially “significantly reduce the cost, resources and delays associated with the current lack of real-time high-resolution imaging.” SamanTree says FDA clearance marks a “crucial moment” in its mission to expand its imaging solutions globally.
With clearance, SamanTree plans to accelerate its U.S. market entry to deliver its technology to more healthcare providers in the country.
“We are thrilled to introduce the Histolog scanner to the U.S. market,” said Dr. Charles Carignan, SamanTree executive chair. “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.”
