COLOMBIA – South Korea’s molecular diagnostics firm Seegene Inc. is expanding operations in the Brazilian market after Anvisa, the country's health care surveillance agency, cleared its multi-assay product through a COVID-19 emergency pathway. Seegene manufactures Allplex, a SARS-CoV-2/FluA/FluB/RSV test able to screen and differentiate eight targets.
Braincool AB has scored a breakthrough device designation from the U.S. FDA for its Cooral system, a medical cooling technology for therapeutic hypothermia and oncology. The status acknowledges Cooral’s potential to prevent oral mucositis (OM), a complication of chemotherapy.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA cites pivotal study failure for Lutonix 014; HHS adds to PREP Act immunity; Dermal fillers on tap at FDA advisory; GAO urges a pause in VA EHR deployment.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aziyo Biologics, Blackrock Microsystems, Clearpoint Neuro, Dexcom, Falcon, Mallinckrodt, Mrs Allergy, Nex Cubed, Picosun Oy, Sharecare, Spineway.
Keeping you up to date on recent developments in neurology, including: Understanding ‘brain fog’ in people with COVID-19; AD diagnostics could become more accessible; Careful with that BBB.
RSS
