CoapTech has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ultrasound gastrostomy system, point-of-care ultrasound magnet aligned (PUMA)-G.
The PUMA-G system enables physicians to place percutaneous gastrostomy feeding tubes at the point of care with the help of solely ultrasound imaging.
PUMA-G is beneficial when compared to conventional procedures that require a surgical suite, additional speciality consultant providers, and expensive and invasive imaging.
The ultrasound-based system for placing enteral feeding tubes eliminates the need for a surgical suite and has the potential to improve safety and cost-effectiveness.
CoapTech founder and chief medical officer Steven Tropello said: “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 utilise 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.”
The company noted that the PUMA-G System is the first approved application of its PUMA System platform.
CoapTech CEO Howard Carolan said: “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.”