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. Read More
The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion. Read More
Tonix Pharmaceuticals Holding Corp. is looking to lessons from tuberculosis and smallpox to guide its future in infectious diseases. The company is developing an intradermal skin test like that used for TB to measure T-cell immunity to SARS-CoV-2, the virus that causes COVID-19. It also has three vaccines in development for COVID-19 that rely on horsepox, likely the form of vaccinia used by Edward Jenner to create the smallpox vaccine. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year. Read More
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. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson. Read More
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. Read More
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. Read More
