SamanTree Medical, a Switzerland-based provider of surgical imaging solutions, has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its Histolog Scanner, a device designed for imaging the internal microstructure of tissues.
The scanner enables the identification of cells, vessels, and their organisation or architecture, providing real-time, high-resolution imaging of fresh tissue surfaces. This information is made available to surgeons and pathologists handling excised tissues.
The Histolog Scanner employs ultra-fast confocal microscopy, allowing for immediate imaging of resected tissues. As per SamanTree Medical, this technology aims to help physicians improve their efficiency in clinical settings.
SamanTree Medical executive chairman Charles Carignan said: “We are thrilled to introduce the Histolog Scanner to the US market.
“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.”
With the FDA clearance, SamanTree Medical is expected to expand its imaging solutions in the US, aiming to enable more healthcare providers to benefit from this technology. The company said that this is a significant step towards its goal of expanding globally.
The Histolog Scanner is described as a plug-and-play device suitable for operating theatres and pathology laboratories. The procedure for using the scanner involves dipping fresh tissue in a fluorescent dye for 10 seconds, rinsing it, and then scanning.
Scanning specimens up to approximately 17cm² takes less than a minute, and the device provides easy-to-read images of the whole surface area, ensuring that no cancer cells remain, as per the company’s claims.
The Histolog Scanner, which has held the CE mark since 2018, is a digital microscopy scanner that uses a novel ultra-fast confocal microscopy technology, invented at the École Polytechnique Fédérale de Lausanne (EPFL) research institute and university in Switzerland in 2010. Its design aims to facilitate quick assessments at the point of care, allowing clinicians to visualise cancerous cells on surgical specimens with a single touch on the screen.
