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FDA clears new Endoflip system for assessing motility disorders
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The FDA has granted 510(k) clearance to the endoscopic diagnostics company Crospon for its new Endoflip system with Flip Topography Module, which provides a new way to evaluate motility disorders during endoscopy.
“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,” John O’Dea, CEO and Founder of Crospon, said in a press release.
The next generation Endoflip 2.0 system comes with new imaging software that displays esophageal contractility patterns in real-time on a 24-inch touch-screen, and its repetitive visual cues enable endoscopic assessment of motility disorders like achalasia and GEJ outflow obstruction.
The system also enables image storage in electronic 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 5 minutes during upper endoscopy on a sedated patient,” O’Dea said in the release. “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.”
The company said it expects the new product to be available in June.
Disclosures: O’Dea is employed by Crospon.