Endoscopic diagnostic company Crospon said today it won FDA 510(k) clearance for its next-gen Endoflip system with Flip topography module, designed to allow clinicians to assess patient motility disorders during endoscopy.
The newly cleared Endoflip 2.0 system includes imaging software that displays esophageal contractility patterns in real time on a touch screen display, the Ireland-based company said.
“This clearance represents a significant milestone for our organization 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” CEO & founder John O’Dea said in a prepared statement.
The system allows operating clinicians to investigate for conditions including achalasia, GEJ outflow obstruction and other major or minor peristalsis disorders during endoscopy, as well as the ability to capture and store Endoflip images in patient records.
“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. In addition to significantly reducing discomfort, the patient may not have to wait for testing at a specialized center, thereby reducing their time to treatment. While not always a substitute for manometry, Endoflip 2.0 can reveal situations of non-obstructive dysphagia which may benefit from further evaluation from manometry,” O’Dea said in a press release.
Crospon said it will begin shipping the Endoflip 2.0 systems in June.