The U.S. FDA is undergoing a significant overhaul of operations which is designed in part to make the agency’s Office of Regulatory Affairs (ORA) more efficient and less obtrusive to product centers, such as the Center for Devices and Radiological Health. Read More
Getting revolutionary genetic medicines to the right place is the reason Genedit Inc. was created, and CEO Kunwoo Lee pared down the mission in one word. “Delivery, delivery, delivery,” Lee told BioWorld in describing the goal of Genedit’s Nanogalaxy platform that is focused on delivering genetic medicines into select tissue. Privately held Genedit will work with Genentech to find and develop hydrophilic nanoparticles for creating nucleic acid-based drugs to treat autoimmune diseases. Genedit is getting $15 million up front in a new deal that could bring in up to $629 million in near-term, preclinical and clinical development, commercial and net sales milestones. Read More
B-rayz AG received CE mark for its Data Adaptive Neural Artificial Intelligence (DANAI) technology that helps clinicians with breast cancer detection. The company hopes that DANAI, which introduces a custom AI-based framework that can adapt to clinicians needs and grow smarter in the process, will revolutionize the diagnostic landscape for breast imaging and transform the lives of millions of women. Read More
Legislation passed in the U.S. Congress in 2013 called upon the federal government to dispense with the Federal Helium Reserve by September 2021, a deadline that some stakeholders are grateful to see has passed without action. Read More
A new wearable “hip-assist” robot developed by Samsung Electronics Co. Ltd. significantly improves gait, balance and dynamic movement in older adults and has the potential to not only enhance physical function but also mitigate the risk of falls. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Baird, BD, Bostongene, Dnanexus, Hamilton, Heartflow, Hummingbird Diagnostics, Sequre, Serosep, Synthego, TMA Precision Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amadex, Angiodynamics. Read More
