Olympus gains 510(k) clearance for colonoscopes

Olympus (TYO:7733) announced that it has received FDA 510(k) clearance for its PCF-H190T and PCF-HQ190 colonoscopes.

Center Valley, Pa.-based Olympus’ two newly cleared colonoscopes provide an extension to the existing capabilities of physicians to diagnose and treat disorders of the gastrointestinal tract, according to a news release.

PCF-H190TL/I is a slim, short-bending scope designed for tighter angulation without compromising the passage of treatment accessories, the company said. The HD device uses narrow-band imaging to assist an endoscopist using a validated polyp classification system.

The new PCF-HQ190L/I includes dual-focus technology for increased mucosal visualization with its near-focus mode associated with a more than 90% agreement with pathological analysis in assigning post-polypectomy surveillance following a colonoscopy.

“With these GI endoscopes, Olympus continues to raise the bar on increased functionality, bringing the market a slimmer diameter endoscope, all while providing imaging excellence toward future innovations,” Olympus America VP for endoscopy Kevin Mancini said in the release. “We know our physician customers are excited about these advancements that will improve their access and visualization of the anatomy as well as a growing range of treatment modalities.”

Original Article: https://www.massdevice.com/olympus-gains-510k-clearance-for-colonoscopes/