CoapTech announced today that it received CE mark approval and an approved CPT procedure code for its PUMA-G ultrasound gastrostomy system.
Baltimore-based CoapTech’s PUMA platform consists of minimally invasive devices designed to enable ultrasound for use in procedures in hollow organs of the body in which it was previously impossible or unsafe to do so, according to a news release.
PUMA-G, the first application of the PUMA platform, holds FDA clearance as a procedural kit allowing bedside clinicians — rather than consultant specialists — to place gastrostomy tubes using solely ultrasound alongside existing skillsets and their teams.
With the newly obtained CE mark approval, CoapTech said it intends to begin a targeted launch of PUMA-G in Europe later this year.
“CE Mark approval allows the PUMA-G System to be sold in Europe and is a major milestone enabling CoapTech’s commercial success,” CoapTech co-founder & CEO Ho…