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BioWorld - Sunday, March 29, 2026
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3D illustration of transparent human torso with close up of spinal cord

Nevro wins CE mark for spinal cord stimulation technology

Nov. 13, 2024
By Shani Alexander
Nevro Corp. received CE mark certification for its HFX iQ spinal cord stimulation system that delivers pain relief.
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Cleerly Labs product suite

Cleerly scores win with four-MAC coverage of AI-QCT

Nov. 13, 2024
By Mark McCarty
Device makers are not necessarily fond of the need to acquire Medicare coverage by picking off one Medicare administrative contractor at a time, but Cleerly Labs Inc. worked this path with gusto.
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Appointments and advancements for November 13, 2024

Nov. 13, 2024
New hires and promotions in the med-tech industry, including: Genedit, Oncohost.
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Financings for November 13, 2024

Nov. 13, 2024
Med-tech firms raising money in public or private financings, including: Debx Medical, Glucotrack, Medeloop, Metasight Diagnostics, QT Imaging.
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In the clinic for November 13, 2024

Nov. 13, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Intelligent Bio Solutions.
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European Union flag with wooden gavel

New notified body survey highlights role of poor-quality submissions

Nov. 13, 2024
By Mark McCarty
The European Commission posted the results of the latest survey of notified bodies, and as the saying goes, there’s good news and bad news.
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Other news to note for November 13, 2024

Nov. 13, 2024
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avita, Heartsciences, ICU Medical, Lunit, Mainz Biomed, Otsuka, Qiagen, QT Imaging, Shineco, Vidi.
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Regulatory actions for November 13, 2024

Nov. 13, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fourth Frontier, GE Medical, Med-El, Smartcardia.
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Illustration of ecDNA inheritance in cancer

Extrachromosomal DNA acts as joker for cancer cells

Nov. 13, 2024
By Mar de Miguel
Cancer therapies can eliminate specific tumors based on their genetic content. However, some cancer cells survive. How do they do it? Part of the answer lies in extrachromosomal DNA (ecDNA), an ace up the tumors’ sleeve to adapt and evade attack. Three simultaneous studies in the journal Nature lay all the cards on the table, revealing ecDNAs’ content, their origin, their inheritance, their influence in cancer, and a way to combat them.
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Laptop displaying FDA logo

​Owens & Minor draws FDA warning for lack of sterilization documentation

Nov. 12, 2024
By Mark McCarty
The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide.
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