Stereotaxis Inc. and Chinese partner Shanghai Microport EP Medtech Co. Ltd. gained the National Medical Products Administration’s approval of its Magbot magnetic navigation ablation catheter Dec. 9 for use with Stereotaxis’ robotic ablation system to treat drug-resistant cardiac arrhythmias in China.

Administrators at the U.S. Medicare program have proposed to cover the Cardiomems remote monitoring device for heart failure, but cardiologists are averse to several of the conditions spelled out in the draft coverage memo, including what they see as a somewhat futile demand for a comparator arm in the proposed coverage study.

The FDA’s new program for communicating the hazards of devices is in play and resulted in the posting of a notice of a problem seen with the Ivenix line of large volume infusion pumps by Fresenius Kabi USA, which will require some repair work by the manufacturer.

Europlaz Technologies Ltd. has developed a new neonatal flow sensor that could help improve neonatal care and save the lives of babies born prematurely. The company created an integrated ‘sidestream’ carbon dioxide (CO2) sampling port, which when added to the side of its existing neonatal flow sensor will enable clinicians to monitor CO2 being exhaled from the baby’s lungs to better inform care.