The U.S. FDA has permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in those ages 2 and older. This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible, FDA officials say.

The U.S. FDA has cleared KD203, a portable multispectral medical imaging device developed by Calgary, Alberta, Canada-based Kent Imaging. KD203 provides insight into the availability of oxygenated blood in tissue, thus streamlining diagnosis, treatment planning, and patient monitoring.

The U.S. FDA has cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope, manufactured by Pentax of America, is intended to provide visualization and access to the upper GI tract.

The U.S. FDA has recognized four AAMI standards and one technical information report―TIR69, which helps provide a reliable method to assess how well wireless medical device systems are able to operate in an increasingly congested wireless environment.

Accuray Inc., Sunnyvale, Calif., has received FDA 510(k) clearance for its iDMS Data Management System, enabling its use with the company’s TomoTherapy platform. The system is designed to integrate with a wide range of technologies.