Crospon Receives 510(k) FDA Clearance for Endoflip® with Flip® Topography Module

Wednesday, October 28, 2020

Company reports that the new Endoflip® System Will Greatly Improve the Quality of Patient Experience During Swallow Testing

Crospon, an endoscopic diagnostics company, today announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Endoflip® System with Flip® Topography Module, providing a new way for clinicians to assess patient motility disorders during endoscopy.

Continuing Crospon’s commitment to deliver information into the hands of gastroenterologists, the next generation of the Endoflip® System, Endoflip® 2.0, introduces imaging software that displays real-time esophageal contractility patterns on a 24” touch-screen. The unique repetitive visual cues of the patented Endoflip® technology enables gastroenterologists, for the first time, to investigate for conditions such as achalasia, GEJ outflow obstruction and other major or minor disorders of peristalsis during endoscopy. EndoFLIP 2.0 also introduces the new capability to capture and store Endoflip® images in electronic patient records.

John O’Dea, CEO and Founder of Crospon highlights, “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.”

O’Dea concluded, “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 specialised 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 notes that shipments of Endoflip® 2.0 systems will commence in June 2017.

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