The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual worldwide revenue. Read More
The FDA town hall on the final day of the 2023 edition of the Med Tech Conference included the usual patter about the achievements at the agency’s Center for Devices and Radiological Health (CDRH), but a few useful nuggets of information nonetheless slipped through in this year’s session. CDRH director Jeff Shuren acknowledged that the agency is steering device advisory committee hearings away from votes on whether to approve a product, an approach he said is under consideration at the agency’s other product centers as well.
AOA Dx Inc. closed an oversubscribed $17 million seed round to expand the clinical trial for its ovarian cancer diagnostic test, build out new lab facilities and explore applications of its Glycolocate platform in other cancers. The platform uses tumor marker gangliosides to enable early cancer. A recent study demonstrated that the test had more than 90% sensitivity and specificity for ovarian cancer detection across all stages. Read More
Responding to the burgeoning field of digital health, the U.S. FDA reported the creation of a new Digital Health Advisory Committee that it expects to be up and running in 2024. Read More
Aurimod GmbH’s CEO, Stefan Kampusch, reported filing patent protection for a device for auricular punctual stimulation and the treatment of pain that comprises a current generator for generating stimulation current pulses and electrical lines for connection to an electrode to be positioned on the ear. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptivendo, AI Medical Service, Cryoport, Endosound, GE Healthcare, T2 Biosystems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Neoss, Orthofix Medical, Sentiar. Read More
