Selio Medical Receives FDA Clearance for Ground-breaking Lung Biopsy Plug System

Selio Medical, a Dublin-based EIT Health-supported start-up, has recently received U.S. Food and Drug Administration (FDA) clearance for its novel medical device designed to improve the safety of lung cancer diagnosis.

The company’s Pre-B. Seal Lung Biopsy Plug System is now the first FDA-cleared device specifically indicated to reduce lung biopsy-associated pneumothorax using a prophylactic pre-sealing approach.

Lung biopsy is a critical step in diagnosing lung cancer, but it carries a significant risk of complications, particularly pneumothorax (collapsed lung), which can result in prolonged hospital stays, patient discomfort, and increased healthcare costs. Selio Medical’s Pre-B. Seal device aims to address these challenges by sealing the lung before the biopsy is performed, reducing the risk of air leakage and other complications. The device provides pneumothorax protection for the patient, enabling the patient to safely return home on the same day as their biopsy procedure.

The FDA’s decision marks a significant milestone for Selio Medical as it continues to build solutions to reduce complications and improve outcomes for patients undergoing other diagnostic and therapeutic procedures.

“Our team is incredibly proud to reach this pivotal milestone,” said Colm McGarvey, CEO of Selio Medical. “FDA clearance is validation of our novel approach to reduce biopsy complications. With the Selio Pre-B Seal, we believe we can transform lung biopsy into a safer, more accessible procedure for millions of patients worldwide, while also significantly reducing costs for healthcare systems.”

Selio Medical, is a spin out from Trinity College Dublin  and the EIT Health-supported BioInnovate Fellowship programme at the University of Galway. The company was later awarded an EIT Health Headstart funding for a proof of concept and subsequent funding under an EIT Health Innovation Project

The FDA approval builds on Selio Medical’s momentum following its €2.5 million award from the EIC Accelerator programme in 2022. With a mission to improve access to safer, more reliable diagnostic tools for patients worldwide, the company is now raising funding to support its next phase of growth and actively seeking partners aligned with its mission.

Discover how Selio Medical is transforming lung cancer diagnosis with FDA-cleared innovation and explore how EIT Health’s programmes, and network support can boost your start-up’s journey from concept to global impact.