Mednax Inc. has inked a definitive agreement through which Radiology Partners will acquire the former's radiology solutions group for $885 million, with an eye toward creating a provider of comprehensive radiology and teleradiology services. El Segundo, Calif.-based Radiology Partners is a physician-owned, on-site radiology practice that partners with about 1,600 radiologists providing services to nearly 1,300 hospitals, clinics and imaging centers across 26 states. When the transaction wraps up, the combined organization, operated under the Radiology Partners name, will include more than 2,400 radiology physicians who provide services in every state plus Washington. Read More
The rescission order directing the U.S. FDA to abandon regulation of lab-developed tests is scarcely three weeks in the past, but two senior managers at the FDA are pushing back in an editorial appearing in the New England Journal of Medicine. The FDA’s Jeff Shuren and Tim Stenzel wrote that there is “a need for a common legislative framework” to ensure clinical tests are accurate and reliable, which implicitly concedes that the statute does not authorize the agency to regulate lab-developed tests. Read More
RapidAI, which focuses on imaging for stroke, has launched the Rapid Web App to help stroke teams stay updated on imaging results and communicate securely. Using the app, team members can receive real-time browser notifications of new cases, preview Rapid results and source files and engage in workflow communications via a desktop or laptop computer. Read More
Oncomfort SA finalized a €10 million (US$11.8 million) series A fundraising round to further develop its Digital Sedation product and pursue international expansion. Debiopharm and Crédit Mutuel Innovation led the round with participation from Wallonia Innovation and Growth and previous investors. Read More
HONG KONG – Technology took the front seat for a second day, at the 2020 KoNECT-MOHW-MFDS International Conference, with a discussion about the South Korean medical devices landscape attracting both criticism and praise. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) said industry stakeholders supported making in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza but self-tests for cancer and genetic testing for health-related purposes should continue to be prohibited from supply. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avenu Medical, Axonics, Hyperfine, Medifiber, Reshape Lifesciences. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Exsomed, Glaxosmithkline, Innoviva, Izi Medical, Verily. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: C.R. Bard, Senseonics, Sterigenics. Read More
Keeping you up to date on recent developments in diagnostics, including: Deep learning aid for diagnosing TB in HIV patients; Self-collected swabs vs. health care worker collected for COVID-19 testing; SCAD vs. plaques in heart attacks; Diagnosing neuroblastoma in children. Read More