Endoscopic diagnostics firm Crospon has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Endoflip system with Flip topography module.
The next generation of the Endoflip system, Endoflip 2.0, will help to evaluate patient motility disorders during endoscopy.
Functional luminal imaging probe technology (Flip) is said to use high-resolution impedance planimetry during volume-controlled distension to measure luminal geometry and pressure .
It will also help to evaluate the mechanical properties of the esophageal wall and opening dynamics of the gastroesophageal junction in various esophageal diseases.
Endoflip 2.0 includes imaging software, which shows real-time esophageal contractility patterns on a 24 touch-screen.
The patented Endoflip technology will allow gastroenterologists to study conditions such as achalasia, GEJ outflow obstruction and other major or minor disorders of peristalsis during endoscopy.
In addition, the system includes new feature that can capture and store Endoflip images in electronic patient records.
Crospon CEO and founder John O’Dea said: “This clearance represents a significant milestone for our organisation as we can now offer physicians an additional tool that can be used during endoscopy, along with other diagnostic methods, to evaluate patients with symptoms consistent with gastrointestinal motility disorders.
“The stand out benefit of this application, for both patients and caregivers, is that the Flip® Topography assessment can be performed in less than five minutes during upper endoscopy on a sedated patient.”
Established in 2006, Crospon is engaged in the designing and manufacturing of medical devices for use in endoscopic and laparoscopic procedures.
Image: Crospon’s Endoflip system with Flip topography module. Photo: courtesy of Business Wire.