Technology | March 14, 2013

FDA Clears Invendo Medical’s Computer-Assisted Single-Use Colonoscopy System

New York-based hospitals are first to make new endoscope for colon cancer screening available to U.S. patients

March 14, 2013 — invendo medical announced it has entered the U.S. market with the first installation of systems at two renowned GI endoscopy centers, NYU Langone Medical Center and New York-Presbyterian Hospital/Columbia University Medical Center. The first U.S. patients have already undergone a colonoscopy with the new C20 colonoscopy system, including the SC20 single-use colonoscope.

This initial entry of the U.S. market follows a special 510(k) clearance by the U.S. Food and Drug Administration (FDA), which cleared several important product improvements for marketing.

The invendoscope SC20 has several features that are new to the field of colonoscopy:

  • It is a single-use colonoscope with a working channel.
  • It is not pushed or pulled, but uses a computer-assisted ("robotic") gentle drive technology.
  • All endoscopic functions are performed using a handheld device.
  • It reduces forces on the colon wall.

"We are proud that two such highly regarded clinical institutions have decided to offer their patients an additional option for colonoscopy," said John J. Cifarelli, executive vice president of global markets for invendo medical. "We are enthusiastic about the potential of our colonoscopy system and are confident that many U.S. patients will appreciate the benefits of the invendo system when they have to decide which screening method would suit them best."

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