Summary: SamanTree Medical’s Histolog Scanner, which provides real-time imaging of tissue microstructures, has received FDA 510(k) clearance. The clearance supports the company’s plans to enter the U.S. market and offer its advanced imaging technology to more healthcare providers.
Key Takeaways:
- The Histolog Scanner provides real-time, high-resolution imaging to enhance surgical and pathological decision-making.
- FDA clearance facilitates SamanTree Medical’s expansion into the U.S. market, broadening access to its innovative imaging solutions.
SamanTree Medical has received FDA 510(k) clearance of its Histolog Scanner for imaging the internal microstructure of tissues, including, but not limited to, the identification of cells, vessels, and their organization or architecture.
Device Capabilities and Intended Use
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 scanner enables real-time confocal microscopy, allowing for the immediate imaging of resected tissues, which aims to improve physicians’ 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.”
Impact of FDA Clearance
The FDA clearance of the Histolog Scanner marks a crucial milestone in SamanTree Medical’s aim to expand its imaging solutions globally. With FDA clearance, SamanTree plans to accelerate its U.S. market entry, ensuring that more healthcare providers can leverage its imaging technology.
