Triopsy Medical, Inc. obtains FDA 510(k) clearance for its Integrated Biopsy System

Novel offering that addresses the clinically-significant unmet need for standardization of prostate biopsy tissue acquisition and transfer

AURORA, CO, UNITED STATES, January 23, 2025 /EINPresswire.com/ -- Triopsy Medical, a privately-owned medical device company that designs and manufactures innovative biopsy devices to aid in diagnosis and treatment management of prostate cancer and others cancer, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its groundbreaking Integrated Biopsy System actuator and 5.5 cm biopsy needle.

"We are thrilled to bring our suite of innovative biopsy devices to the market," said Dr. David Bostwick, Chief Executive Officer of Triopsy Medical. "The Triopsy Integrated Biopsy System offers multiple significant advantages over existing old technology. Improvements include more accurate targeting of suspicious lesions (less deflection) with our patented trochar needle tip, acquisition of the precise length of desired biopsy tissue with the first and only fully-adjustable actuator, and ease of tissue handling in the laboratory without fragmentation or distortion with the unique Biopsy Grip.TM This combination of three novel offerings addresses the clinically-significant unmet need for standardization of biopsy tissue acquisition and transfer of its entire length and intact quality. It is likely that this will decrease variance and thereby improve cancer yield and diagnostic accuracy while simultaneously simplifying and speeding the process of biopsy and tissue handling.”

“The Integrated Triopsy Biopsy System is intended to save time, reduce costs, and will be the first to be able to take consistent tissue samples, which are badly needed to provide the consistent data necessary for correlated data to be used with artificial Intelligence. Our objective is to develop a large enough database to aid future surgical treatment innovation, drug development and, in the near future, Immunology tools to arrest certain cancers before they develop.” Said Brad J. Buscher, Executive Chairman and founder of Triopsy Medical, Inc.

The Triopsy Integrated Biopsy System was designed for safety and convenience, and aims to set a new standard in biopsy procedures by reducing frustration and improving efficiency. Triopsy is dedicated to developing solutions that elevate the practice of urology and interventional radiology, and the FDA clearance of the Triopsy needles and actuator marks a significant milestone in that mission.

For further information:
Web: www.triopsy.com
About Triopsy
Triopsy™ is a privately-owned medical device company established by practicing physicians to confront the pressing need for a more precise cancer diagnosis, with initial focus on prostate cancer. Our pioneering Triopsy™ Integrated Biopsy System, featuring the Actuator, Needle, and Biopsy GripTM, is dedicated to enhancing biopsy precision, sampling areas that frequently elude diagnosis and elevating diagnostic accuracy for each patient in the battle against cancer.

David G. Bostwick, MD, MBA
Triopsy Medical, Inc.
+1 804-677-8527
dbostwick@triopsy.com
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