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. The EC had previously prohibited the deal over concerns that the merger would stifle innovation and reduced choice in the emerging market for blood-based early cancer detection tests. However, San Diego-based Illumina, completed the $7.1 billion acquisition of cancer diagnostic test maker Grail, of Menlo Park, Calif., while the EC's review of the deal was going on.
FDA’s Shuren says agency decidedly moving away from up-or-down vote at advisory hearings
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 nabs $17M for ovarian cancer diagnostic
AOA Dx Inc. closed an oversubscribed $17 million fundraising 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.
FDA creates new Digital Health Advisory Committee
The U.S. FDA established a new Digital Health Advisory Committee that it expects to be up and running in 2024. The new group will help the agency address the wide range of issues surrounding digital health technologies that have burgeoned since the pandemic, including artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.
Aurimod reveals the workings of its device for personalized auricular vagus nerve stimulation
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, of which at least two can be acted upon by the stimulation pulses, and that further comprises means for determining patient physiological parameters (heart rate, heart rate variability, blood flow, vascular stiffness and/or respiratory rate) by measuring impedance plethysmography across the electrodes.
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