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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Sep. 11, 2024

View Archived Issues
HyperVue Feature Updates

Spectrawave’s Hypervue sees $50M in support

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. Read More
Regulatory-US-FDA-HQ.png

FDA’s patient preference draft implicates product labeling

The FDA’s Sept. 5, 2024, draft guidance for the use of patient preference information (PPI) over the total product life cycle represents a new set of requirements for device makers when obtaining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. Read More
Heart, DNA and ECG

Drai Martini study underscores value of AI in heart rhythm analysis

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. Read More
T cells

Autoimmune T cells may be beneficial for CNS injuries

Immunotherapy based on T cells is the vanguard of cancer treatments. Researchers from Washington University in St. Louis have shown that similar approaches using T cells could be applied for treating injuries of the central nervous system (CNS). They reported their findings in Nature on Sept. 4, 2024. Read More
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EMA advises competent authorities to exercise caution in use of LLMs

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. Read More

Appointments and advancements for September 11, 2024

New hires and promotions in the med-tech industry, including: Breg, Io Urology, Nextsense, Procyrion, Quidelortho. Read More

In the clinic for September 11, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avenda, Cairn . Read More

Other news to note for September 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. Read More

Regulatory actions for September 11, 2024

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Deepwell, Irhythm, Tyber. Read More

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