Check-Cap Ltd., of Isfiya, Israel, reported positive results from a U.S. pilot study of its C-Scan System, a preparation-free, ingestible scanning capsule-based technology aimed at preventing colorectal cancer (CRC) through early detection of precancerous polyps. The company is currently preparing an IDE submission with the U.S. FDA and plans to launch a pivotal clinical trial in late 2020. Read More
HONG KONG – Aiming to attract more active innovation to its medical device industry, South Korea updated some of its industry regulations through 2019. The ultimate goal was to make it easier for advanced medical technologies that use artificial intelligence (AI), robotics and 3D printing that have yet to penetrate the market due to inefficient approval processes. Read More
BOGOTA, Colombia – A startup in Mexico has developed an intelligent glove to diagnose cardiac diseases in seconds just by touching a patient’s chest. The invention could become available on the market by the end of 2020, when Soluciones Kenko, from Jalisco, Mexico, expects to hit the Mexican market with a futuristic solution for the health care sector. Read More
The FDA's revised draft guidance for clinical decision support (CDS) systems was intended to fix several glaring holes in the first draft, but multiple stakeholders argued that the second draft contradicts the related provisions of the 21st Century Cures Act when it comes to CDS systems that purport to drive or guide clinical decision making. Read More
Genome sequencing is enabling new insights into the genetic aspects of health and disease that have touched just about every aspect in biomedicine. It is also, like the “skin”-colored crayons of yore, disproportionately focused on the Caucasian segment of the population. And that is a loss for everyone. Read More
