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BioWorld - Sunday, February 22, 2026
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In the clinic for September 12, 2024

Sep. 12, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, CVRx.
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Graph showing voltage of cell membrane's change over time
Cancer

Focusing on tumor cells brings insights into cancer neuroscience

Sep. 12, 2024
By Anette Breindl
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.
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HyperVue Feature Updates

Spectrawave’s Hypervue sees $50M in support

Sep. 11, 2024
By Annette Boyle
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.
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Heart, DNA and ECG

Drai Martini study underscores value of AI in heart rhythm analysis

Sep. 11, 2024
By Shani Alexander
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.
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U.S. FDA headquarters

FDA’s patient preference draft implicates product labeling

Sep. 11, 2024
By Mark McCarty
The FDA’s Sept. 5, 2024, draft guidance for the use of patient preference information (PPI) over the total product life cycle represents a new set of requirements for device makers when obtaining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.
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Appointments and advancements for September 11, 2024

Sep. 11, 2024
New hires and promotions in the med-tech industry, including: Breg, Io Urology, Nextsense, Procyrion, Quidelortho.
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In the clinic for September 11, 2024

Sep. 11, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avenda, Cairn .
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Cyber eye illustration

EMA advises competent authorities to exercise caution in use of LLMs

Sep. 11, 2024
By Mark McCarty
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.
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Other news to note for September 11, 2024

Sep. 11, 2024
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3comma Medical, Astrazeneca, Chemomouthpiece, Comercial Medico, Creal, Deroyal Industries, Electromed, Femasys, Flowphysix, Getinge, Infusystem, Mevion Medical, Nelco Worldwide, Paragonix, Sanara Medtech, Sophia Genetics, Stryker, Surgibox, Zeiss.
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Regulatory actions for September 11, 2024

Sep. 11, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Deepwell, Irhythm, Tyber.
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