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. Read More
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. Read More
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. Read More
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. Read More
It’s difficult to fathom that the health of half the world’s population is underserved. But it’s a hard truth. Women’s health has traditionally focused on what Seema Kumar, the CEO of Cure, coined as the “bikini zone.” However, reproduction and breast health are a drop in the bucket when it comes to women’s health. In this multipart, in-depth series, BioWorld provides insight into the oft-overlooked space of women’s health, exposing the disparities in research and funding while looking toward future opportunities for bridging the gender gap in health care. Read More
Karen Carey, BioWorld’s managing editor and chief analyst, and Anette Breindl, managing editor of Bioworld Science, join this episode of the BioWorld Insider podcast to talk about the business and the science of women’s health. Read More
New hires and promotions in the med-tech industry, including: Association for Diagnostics & Laboratory Medicine, Foxo Technologies, Hologic, Mentice, Quidelortho, Sapient. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cerapedics, Combinostics, Deegtal Insight, Dynocardia, Endoquest, Foxo Technologies, Labcorp, Principle Health Systems, Protaryx, Synthetic MR, Telos, Wyss Center. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neuraxis, Pentax Medical. Read More