A Medical Device Daily

Given Imaging (Yokneam, Israel) reported receiving marketing clearance from the FDA for Rapid Access RT, a hand-held device that enables real-time viewing during a PillCam endoscopy procedure and Rapid Access, the software installed on the device.

Rapid Access also allows physicians to remotely initialize a DataRecorder to administer the company's PillCam video capsules to patients at satellite sites. Data can then be sent to a central location for processing and interpretation.

Several physicians in Europe were selected as beta sites to test RAPID Access. Professor Guido Costamagna, head of the division of digestive endoscopy at Gemelli Hospital of the Catholic University (Rome), said, “Real-time viewing will improve physician reading times for esophageal procedures and validate the completion of small bowel procedures.”

Given Imaging has pioneered a redefinition of gastrointestinal diagnosis by developing a complete line of PillCam video capsules for detecting disorders of the gastrointestinal tract.

The company's technology platform is the Given Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient and provides direct visualization of the entire small intestine. It is currently marketed in the U.S. and in more than 50 other countries and has been used in more than 340,000 procedures worldwide.

The PillCam ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development.

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