Single Pass has announced that its Kronos biopsy closure device, a Class II medical device, has received clearance from the US Food and Drug Administration (FDA).
The FDA has confirmed that the device is substantially equivalent to its predicate devices in terms of safety and effectiveness.
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With this clearance, the device can now be available for commercial use in the country.
The Single Pass team collaborated with its contract manufacturing partner, M4D, to bring the closure device to market.
The device has also achieved the CE Mark under the EU MDR regulations, further solidifying its presence in the international market.
Mermaid Medical, Single Pass’s US distribution partner, is set to commence sales within the US.
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By GlobalDataSingle Pass co-founder and CEO Bill Colone said: “We are thrilled to have received FDA clearance for our Kronos biopsy closure device. The Kronos device represents a significant advancement, offering healthcare professionals a reliable and efficient solution for post-biopsy bleeding and improved patient care.”
The partnership aims to provide immediate national access to the Kronos device, which is expected to benefit patients and healthcare providers across the country through its unique technology.
In February 2024, Single Pass reported the completion of the first live clinical cases in Italy using the Kronos biopsy closure device.
The procedures, which took place at the Universitario Campus Bio Medico and Fondazione Policlinico in Rome, demonstrated the device’s ability to transform biopsy procedures by ensuring precise closure post-biopsy.
The first case involved a kidney biopsy where a 22cm Kronos device was used in conjunction with a 13cm biopsy needle.
The device achieved successful cauterisation and the depth gauge provided accurate targeting.
Earlier this year, the company entered an exclusive distribution agreement with Mermaid Medical Group to introduce the advanced biopsy closure device to the US market.
