Akadeum Life Sciences Inc. hopes to transform the world of cell therapy with the Alerion cell separation system, which it plans to launch in the next 12 months, Brandon McNaughton, founder and CEO of Akadeum, told BioWorld. The instrument will provide a closed system for separating T cells from a leukopak using Akadeum’s buoyancy-activated cell-sorting (BACS) microbubble technology.
The qui tam or whistleblower lawsuit under the U.S. False Claims Act (FCA) has driven a large volume of litigation against life science companies, but three Supreme Court justices expressed misgivings about the constitutionality of the qui tam relator in the Court’s hearing of Polansky. Should a fourth Supreme Court justice harbor similar misgivings, the matter could be ripe for a hearing at the Supreme Court with the possibility that the qui tam relator would then be declared unconstitutional.
The European Union’s Artificial Intelligence Act (AI Act) is widely seen as a groundbreaking piece of legislative handiwork, but companies in the life sciences may see it as a groundbreaker with negative consequences. The latest edition of the AI Act continues to treat medical AI software as a high-risk product, which would make these products exceptionally expensive and burdensome to bring to market in the EU and convince some companies in the medical AI business to skip the European market altogether.
Patent applications from Bellevue, Wash.-based Aiberry Inc. describe further aspects of its artificial intelligence (AI)-powered mental health screening platform that is designed to improve efficiency and save time for healthcare providers.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Belkin Vision, Cryofocus, Zimvie.
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