Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inflammatix, Intelligenome, Roche.
Just a few weeks later than expected, Inflammatix Inc. secured U.S. FDA clearance of the Triverity test system for use in emergency triage of patients with suspected acute infection or sepsis. The molecular blood test is the first to identify bacterial and viral infections and provide an all-cause risk evaluation of the likelihood of developing severe illness.
The European Union has implemented legislation governing artificial intelligence (AI) with more on tap, but the U.S. has to date lagged in that area. However, the House of Representatives has assembled a bipartisan task force for AI, one of several developments suggesting that 2025 will be an even more AI-focused year than 2024.
Regulatory approval for medical products can rely on real-world data (RWD) typically only for expanded indications for use, but payers have been missing in action where this data source is concerned. The U.S. CMS has floated a guidance to facilitate the use of RWD in coverage decisions, providing a long-overdue update to Medicare clinical trial policy.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aidoc Medical, Airs Medical, Cmbio, Concept Medical, Glooko, Guardant Health, Fujifilm Irvine, Medrhythms, Motif Neurotech, Neuraxis, Somalogic, Standard Biotools.
Owlstone Medical Ltd. recently secured $27 million in the first close of its series E financing round for clinical trials and product commercialization based on its Breath Biopsy platform technology. The fundraise was led by Ventura Capital, joined by Aviva Ventures, Horizons Ventures and other existing investors.
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