September 23, 2016

FDA Clears GI View’s Colonoscope

GI View has received FDA 510(k) clearance for a colonoscope device that is disposable, self-propelled, and joystick-controlled. The device now allows for therapeutic access to take biopsies or perform polypectomies.

The Aer-O-Scope uses a soft multi-lumen tube to reduce pressure on the colon wall. The tube is also hydrophilic, which reduces friction between the bowel and scope by more than 90 percent.

CE Mark Granted for Lotus Edge

Boston Scientific has received a CE Mark for its aortic valve system, the Lotus Edge valve system for aortic valve replacement in patients with severe aortic stenosis who are at high risk for surgical valve replacement.

This next generation of development for the system includes the Adaptive Sea technology, which minimizes leaking.

ViewRay Obtains CE Mark for MRI System

ViewRay has received a CE Mark for its advanced linear, accelerator-based, MRI-guided radiation therapy system. The MRI device builds on the first generation MRIdian system, but uses cobalt with linear accelerator technology.

The company has also submitted its 510(k) application for the MRIdian Linac technology in the United States.

FDA Clears Lithoplasty System

The FDA granted clearance to Shockwave Medical’s Lithoplasty System for treatment of calcified plaque in patients with peripheral artery disease (PAD).