Sooma Oy recently raised €5 million (US$5.4 million) in funding to help the company expand access to its transcranial direct current stimulation device which allows patients to treat their depression at home. “This is a significant milestone for us that enables us to help more patients globally and help us develop the company to serve the unmet need,” Tuomas Neuvonen, Sooma's co-founder and CEO, told BioWorld. Read More
The U.S. Environmental Protection Agency (EPA) has issued its long-awaited final rule governing emissions of ethylene oxide (EtO), a rule announced by the agency with the concurrence of Xavier Becerra, the Secretary of Health and Human Services. However, the final rule provoked an immediate response from Sen. Bill Cassidy (R-La.), who said the final rule will “put American lives in danger.” Read More
There are coincidences and then there are big coincidences, the latter of which might describe a new U.S. FDA draft guidance and a major cybersecurity breach. The agency has issued a draft update to its premarket cybersecurity guidance even as the Department of Health and Human Services announced an investigation into the hack of the IT system at Change Healthcare, a pair of developments that seem likely to set the world of connected medical devices on its collective ear. Read More
Medical Korea 2024 opened to a large audience in Seoul, South Korea for a two-day run to highlight advances in the medical field, including those in radiotherapy. Read More
Researchers from the University of Stellenbosch in South Africa are seeking protection for a simple and user-friendly point-of-care device for diagnosing tuberculosis. Their electrochemical lateral flow device merges lateral flow device technology and electrochemical device technology by using porous electrodes that are capable of transporting electrolytic liquid and fluid sample. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Intuitive Surgical, Ortho Development. Read More