The FDA issued 510(k) clearance to invendo medical, a company based in Kissing, Germany, for its invendoscopy E200, a robotically assisted colonoscopy system that uses the single-use invendoscope SC200 as the colonoscope.
Not requiring sterilization between uses, the system may help address associated costs while preventing the spread of nasty lower GI infections.
The remote controlled distal end of the SC200 can flex 180° in any direction and has three white LEDs and a CMOS chip for imaging on the tip. The robotically assisted aspect is that the system can go through an automatic diagnostic mode where the tip moves in circles, making sure the physician gets to see the entire cavity.
There’s a 3.1 mm working channel for introducing instruments for tissue sampling and other procedures. One can also perform rinsing, flushing, suction, and insufflation and there’s also a separate water jet port for other techniques.
“In addition to the clinical benefits associated with reducing potential cross-contamination, the ergonomic design of the invendoscope SC200 offers a ScopeController that contours to the physician’s hand and can be used attached or detached to the endoscope. This unique control body coupled with the lightweight of the colonoscope provides a more comfortable and less tiring procedure for the healthcare provider. The invendoscope SC200 also includes a unique tip for full retroflection in various segments of the colon, enabling inspection behind colonic folds, which is key to a comprehensive diagnosis during colonoscopies,” said John Cifarelli, Chief Commercial Officer of invendo medical in a press release.
Product page: invendoscope SC200…
Via: invendo medical…