Sam Brusco, Associate Editor02.17.22
Unsedated transnasal endoscopy (TNE) company EvoEndo has earned U.S. Food and Drug Administration 510(k) clearance for its EvoEndo single-use endoscopy system. A phased distribution with partner Micro-Tech Endoscopy USA will begin in U.S. hospitals and ambulatory surgical centers (ASCs) shortly.
The EvoEndo system combines sterile, single-use, flexible endoscopes, a portable video controller, and a kit with virtual reality (VR) goggles for patient entertainment and distraction during transnasal endoscopy. The kit is what ultimately allows for an unsedated exam.
The company completed a $10.1 million equity financing round last June.
“Receiving FDA 510(k) clearance for the EvoEndo System will allow us to execute on our mission of enabling a safer, faster, and more affordable alternative to sedated endoscopy for both pediatric and adult patients,” EvoEndo CEO Heather Underwood told the press. “This is an exceptional accomplishment for our team and validates our ongoing commitment to transform best practices in endoscopy and support the broader adoption of unsedated procedures throughout the U.S.”
“With today’s announcement, we are one step closer towards making unsedated endoscopies the standard of care within the medical community,” said Joel Friedlander, chief medical officer and co-founder of EvoEndo. “We are thrilled to receive this clearance and proud to be on the forefront of a new and innovative system to help diagnose and treat pediatric and adult patients.”
"The EvoEndo Model LE Single-Use Gastroscope addresses critical clinical needs in current pediatric and adult endoscopy practice and is a prime example of the innovative medical technology we strive to provide to our network," stated Micro-Tech USA president Chris Li. "A combination of the smaller scope size, larger biopsy channel, coupled with a sterile single-use device can help save valuable procedure time and cost. We look forward to further growing our partnership with EvoEndo and to the successful completion of initial clinical cases."
The EvoEndo system combines sterile, single-use, flexible endoscopes, a portable video controller, and a kit with virtual reality (VR) goggles for patient entertainment and distraction during transnasal endoscopy. The kit is what ultimately allows for an unsedated exam.
The company completed a $10.1 million equity financing round last June.
“Receiving FDA 510(k) clearance for the EvoEndo System will allow us to execute on our mission of enabling a safer, faster, and more affordable alternative to sedated endoscopy for both pediatric and adult patients,” EvoEndo CEO Heather Underwood told the press. “This is an exceptional accomplishment for our team and validates our ongoing commitment to transform best practices in endoscopy and support the broader adoption of unsedated procedures throughout the U.S.”
“With today’s announcement, we are one step closer towards making unsedated endoscopies the standard of care within the medical community,” said Joel Friedlander, chief medical officer and co-founder of EvoEndo. “We are thrilled to receive this clearance and proud to be on the forefront of a new and innovative system to help diagnose and treat pediatric and adult patients.”
"The EvoEndo Model LE Single-Use Gastroscope addresses critical clinical needs in current pediatric and adult endoscopy practice and is a prime example of the innovative medical technology we strive to provide to our network," stated Micro-Tech USA president Chris Li. "A combination of the smaller scope size, larger biopsy channel, coupled with a sterile single-use device can help save valuable procedure time and cost. We look forward to further growing our partnership with EvoEndo and to the successful completion of initial clinical cases."