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BioWorld - Saturday, March 7, 2026
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Kneu secures $5.6M for neurological disorders platform

Oct. 13, 2025
By Shani Alexander
Who knew? In addition to adopting a new name, Kneu Health Ltd. recently raised $5.6 million in a seed funding round for its smart-phone-based platform which helps to monitor neurological disorders to enable timely intervention. The funds secured will be used to expand commercial operations in the U.S., scale deployments for Parkinson's disease and advance the monitoring capabilities of the platform for dementia.
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U.S. Capitol building, Washington D.C.

US federal shutdown bites FDA

Oct. 13, 2025
By Mark McCarty
The budget impasse between Democrats and Republicans on Capitol Hill has implications for a wide range of federal government operations, including at the U.S. FDA, which is absorbing another round of layoffs and cannot accept new premarket filings that require user fee submissions.
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Digital 3-D illustration of Japan's flag, light effects

Japan reimagines mental health care through AI

Oct. 13, 2025
By Tamra Sami
Japan is reimagining how mental health care can be delivered digitally and proactively, with local governments investing in digital technology to create data-driven safety nets that aim to detect distress and deliver help, presenters said during the Bio Japan 2025 conference in Yokohama, Oct. 8 to 10.
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AI-generated digital horse illustration

PTO director strikes a blow for ML patent subject matter eligibility

Oct. 13, 2025
By Mark McCarty
John Squires, the recently anointed director of the U.S. Patent and Trademark Office, has determined that a machine learning (ML) patent application met the standard for patent subject matter eligibility, an outcome that seems to bode well for ML-based patent applications going forward.
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Financings for Oct. 13, 2025

Oct. 13, 2025
Med-tech firms raising money in public or private financings, including: Bluejay.
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In the clinic for Oct. 13, 2025

Oct. 13, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adagio Medical, Billiontoone.
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Other news to note for Oct. 13, 2025

Oct. 13, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1Cell.AI, Accugenomics, Cardiofocus, Dario, Genedx, Hyperfine, Nextbiomedical, Pacbio, Stereotaxis, Upcare Europe.
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Regulatory actions for Oct. 13, 2025

Oct. 13, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Roche, Zeta Surgical.
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Med-tech gainers and losers for Oct. 6-10, 2025

Oct. 13, 2025
The top 10 med-tech stock gainers and losers for the week.
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Illustration of DNA double helixes inside drop of blood
Hematologic

Gene therapy for hemophilia stalls but doesn’t stop at ESGCT

Oct. 13, 2025
By Mar de Miguel
No Comments
While recent advances in gene therapy have offered unprecedented options for patients with hemophilia, new data presented at the 32nd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT), held in Seville Oct. 7-10, revealed persistent concerns regarding the durability of these treatments and their potential liver toxicity.
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