In a task made more challenging by COVID-19, the EU and the World Health Organization are rolling out separate plans to take down cancer in Europe. The European Commission Feb. 3 announced its Europe’s Beating Cancer Plan, the first comprehensive European cancer initiative in nearly 30 years. A day later, WHO/Europe launched its United Action Against Cancer, billing it as a “pan-European cancer movement” to galvanize support and cooperation from grassroots to governments with the long-term goal of eliminating cancer as a life-threatening disease in the region.
PERTH, Australia – Micro-X Ltd. completed an AU$30.5 million (US$23.27 million) placement to expand its U.S. footprint for its lightweight digital mobile X-ray systems. The funds raised will drive market expansion of Adelaide, Australia-based Micro-X’s Rover digital mobile X-ray system that is designed for deployed military medical facilities, and to scale up its Carestream DRX Revolution Nano, a mobile lightweight digital X-ray system for hospitals.
Biosig Technologies Inc. and the Mayo Foundation for Medical Education and Research are jointly developing next-generation artificial intelligence (AI)-powered software for Biosig’s Pure EP electrocardiograph system. The Pure EP system acquires, measures, calculates and stores electrocardiographic and intracardiac signals for patients during electrophysiology procedures. The collaboration aims to expand the captured signals and combine them with other data sources to provide more actionable information.
The U.S. FDA is still struggling to keep up with the volume of diagnostic emergency use authorizations (EUAs), but it is not for want of effort. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said on the Feb. 3 testing town hall that the agency is processing nine such applications per day, a big jump over the rate of one per day in the early weeks of the COVID-19 pandemic.
HONG KONG – Seegene Inc. has developed a COVID-19 test kit that is able to both detect and identify multiple mutant variations of the virus. “Getting test results from the Allplex SARS-CoV-2 Variants Ⅰ Assay takes two hours, which is normally how long getting results from a PCR test takes,” a Seegene spokesperson told BioWorld.
Spectrawave Inc. has scooped up $13.2 million in a series A-2 financing led by prior investor Deerfield Management. The funds will be used to complete development and regulatory filing for its flagship cardiac imaging technology. Prior unnamed seed investors also participated in the round. With this latest infusion, Spectrawave has raised a total of approximately $30 million to date.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force gives CAS screening another thumbs down; USPTO expands program with Japan’s, South Korea’s patent offices; Boston Sci recalls electrode for ICD due to risk of fracture; CDSCO posts lists of approved tests.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clew, Pulse Biosciences.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ardent Health Services, Ams, Axim Biotech, Bendcare, Botanisol Analytics, Casenet, Centene, Color, Colossal Contracting, Congenica, Decipher, Epredia, Extra Horizon, Fujifilm, Gabriel Precision Oncology, Gpm, Histosonics, Inspiremd, McGinley Orthopedics, Medline, Meridian Bioscience, Mobile Heartbeat, Netsmart, New England Biolabs, Ocean Insight, Quantumdx, Veeva, Veracyte, Vizient, Zyter.