Single Pass Announces Receipt of CE Mark for its Biopsy Closure Device

Single Pass, Inc. CEO, Bill Colone, announced today that the company received the CE Mark under EU MDR for its biopsy closure device.

LAKE FOREST, Calif., Nov. 20, 2023 /PRNewswire-PRWeb/ -- Single Pass, Inc. (Lafe Forest, CA) CEO, Bill Colone, announced today receipt of the CE Mark under EU MDR for their Kronos Biopsy Closure device. The cautery device prevents or stops bleeding caused by biopsy tools during co-axial biopsy procedures and is most useful in liver, kidney, lung, and breast biospy procedures.

Colone added "receipt of the CE Mark under EU MDR represents a significant accomplishment. We can now begin improving the safety of biopsy procedures for patients living in countries where the CE Mark is accepted. We confirmed in our multi-country clinical study that patients and clinicians both benefited from the certainty that the biopsy channel was fully cauterized immediately post procedure. This confirmation significantly reduced the anxiety that currently plagues patients and clinicians during the post procedure observation period".

Single Pass was privately funded in April of 2021 by the co-founders, Angel investors, and investment organizations such as Tech Coast Angels of Orange County, NewFund Ventures, and Kyto Technologies. The company's submission to the FDA is currently under review.

Media Contact

Bill Colone, Single Pass, Inc., 1 6026183377, [email protected], www.singlepass.co

SOURCE Single Pass, Inc.