A business grant of 510K granted to CoapTech by FDA for the successful clearance of its PUMA-G System

A medical-based company which focuses on providing transformative solutions, Coap Tech LLC, made an announcement today that the United States Food and Drug Administration granted the company a business grant of 510K on the 10th of April for its successful clearance of the PUMA-G system.

The Chief Medical Officer and Founder of CoapTech, Steven Tropello passed the following statement: “As a healthcare provider, I have seen the challenges with current gastrostomy methods, and the delays in care and potential harm to patients that can result. The inspiration for this product came after seeing countless patients needing a simple G-tube insertion or replacement who needlessly wound up staying multiple days in the hospital waiting for a specialist and an operating room to be available. Clinicians trained in point-of-care ultrasound will be able to utilize the PUMA-G System to safely and swiftly place a G-tube at the bedside, which should keep patients progressing on their journey towards recovery and home.”

Chief Executive Officer at Coap Tech, Howard Carolan stated: “Our hardworking team is honored to have received FDA clearance as we continue our mission for safer, simpler, and faster patient care. Based upon the success of the PUMA-G System to date, this milestone further motivates us to accelerate the development of other applications, expanding the PUMA platform to provide new solutions for ultrasound-guided procedures in other hollow organs of the body, such as the airway and lung.”

Director at UM Ventures and Associate Vice President at the Office of Technology Transfer, Phil Robilotto passed the following statement: “This is tremendous news for the University of Maryland, Baltimore (UMB) startup CoapTech. UM Ventures participated in CoapTech’s initial financing seed round last year and is very excited by the Company’s continued excellent progress as marked by this  510(k) clearance and the prospect of soon seeing the important PUMA-G technology used in patient care across the United States.”