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Home » FDA clears tissue scanner from SamanTree Medical

FDA clears tissue scanner from SamanTree Medical

September 13, 2024 By Sean Whooley

SamanTree Medical Histolog Scanner (1)
The Histolog scanner for tissue imaging. [Image courtesy of SamanTree]
SamanTree Medical announced today that it 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.

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.”

Filed Under: 510(k), Food & Drug Administration (FDA), Imaging, Regulatory/Compliance Tagged With: SamanTree Medical

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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