By looking at the electrical activity of tumor cells, rather than the neurons that innervate them, investigators at Baylor College of Medicine have added both basic and translational insights to the emerging field of cancer neuroscience. In their studies, which were published in Cancer Cell on Sept. 5, 2024, the researchers identified the cell of origin for IDH-mutated gliomas.
Spectrawave Inc. surfed to a $50 million haul in its series B fundraising round for its Hypervue intravascular imaging system. The company appears to have captured the attention of at least one strategic investor, as Johnson & Johnson Innovation-JJDC Inc. led the round.
Data from the Drai Martini study shows that artificial intelligence is shaking up the analysis of electrocardiograms. Results presented at the recent ESC Congress 2024, demonstrated that an AI algorithm, Deeprhythmai, developed by Medicalgorithmics Sp zo.o., has significantly higher sensitivity than human specialists in detecting heart rhythm disorders on long ECG recordings.
The FDA’s Sept. 5, 2024, draft guidance for the use of patient preference information (PPI) over the total product life cycle represents a new set of requirements for device makers when obtaining such information. Going forward, device makers may be required to provide more detail about patient heterogeneity, including when the benefit-risk calculation varies by subpopulation.
The European Medicines Agency advised its member state regulatory partners to closely track how they use LLMs in making regulatory decisions – a clear signal that some regulatory decisions may be inappropriately torqued by their well-known shortcomings.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Deepwell, Irhythm, Tyber.