Tuesday, April 30, 2024
Single Pass is thrilled to announce that its Class II Kronos biopsy closure device has been granted clearance by the U.S. Food and Drug Administration (FDA).
Thorough evaluation, the FDA has affirmed the device's safety and effectiveness, deeming it substantially equivalent to existing predicate devices.
The Single Pass team worked closely with their manufacturing partner, M4D, based in Lake Forest, CA, to bring the Kronos device to market.
Having already secured the CE Mark under EU MDR regulations, the Kronos device is now available for commercial use worldwide.
Excited to have received FDA clearance for our Kronos biopsy closure device," stated Co-founder. The Kronos device represents a significant step forward, offering healthcare professionals a reliable and efficient solution for managing post-biopsy bleeding and improving patient care."
Mermaid Medical, the US distribution partner, is ready to launch sales nationwide, ensuring quick access to this innovative technology across the country.
This strategic partnership promises extensive availability of the Kronos device, ultimately benefiting patients and healthcare providers nationwide.
Source: prnewswire.com
