LAKE
FOREST, Calif., April 29,
2024 /PRNewswire/ -- Single Pass, Inc. is proud to
announce that its Class II Kronos biopsy closure device has
received clearance from the U.S. Food and Drug Administration
(FDA). The FDA has determined the device is substantially
equivalent to predicate devices regarding its safety and
effectiveness.
Under the leadership of Bill
Colone and its Board of Directors, the Single Pass team
collaborated with their contract manufacturing partner, M4D, based
in Lake Forest, CA to bring the
Kronos device to market. The company previously achieved the CE
Mark under the EU MDR regulations, as now the Kronos device is now
commercially available globally.
"We are thrilled to have received FDA clearance for our Kronos
biopsy closure device," said Bill
Colone, Co-founder, and CEO of Single Pass. "The Kronos
device represents a significant advancement, offering healthcare
professionals a reliable and efficient solution for post biopsy
bleeding and improved patient care."
Mermaid Medical, the US distribution partner, is prepared to
initiate sales in the US, ensuring immediate national access to
this groundbreaking technology. This strategic partnership will
facilitate widespread coverage for this innovative and unique
technology ultimately benefiting patients and healthcare providers
across the country.
For more information about Single Pass and its innovative
medical devices, please visit https://www.singlepass.co/.
About Single Pass: Single Pass is a medical device
company dedicated to developing an innovative solution to post
biopsy bleeding, enhance patient care, and improve clinical
outcomes. With a focus on precision and reliability, Single Pass
strives to revolutionize the healthcare landscape through
cutting-edge technology by safely cauterizing deep tissue through a
guide needle, promising swift, easy, and safe biopsy
procedures.
For media inquiries, please contact:
Bill Colone
CEO
Single Pass
+1-602-618-3377
376884@email4pr.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/single-pass-inc-announces-fda-clearance-of-its-kronos-biopsy-closure-device-302130242.html
SOURCE Single Pass, Inc.