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BioWorld - Tuesday, January 13, 2026
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
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BioWorld MedTech
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Heartflow illustration

FDA clears Heartflow’s next-gen plaque analysis

Sep. 23, 2025
By Annette Boyle
Heartflow Inc. hasn’t skipped a beat in pumping out good news, with U.S. FDA 510(k) clearance for its next-gen plaque analysis algorithm and platform and Cigna coverage across all lines of coverage starting in October. The new algorithm improves plaque detection 21% compared to the first version of Heartflow’s algorithm.
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Red arrow pointing downward on a stock market ticker

Funding crisis looms for European med tech

Sep. 23, 2025
By Shani Alexander
The lack of funding available for early-stage European med-tech and AI-based companies could soon see many go under as their current backers run out of capital, and new investors fail to materialize, Hubert Birner, managing partner at TVM Capital Life Science, told BioWorld.
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Appointments and advancements for Sept. 23, 2025

Sep. 23, 2025
New hires and promotions in the med-tech industry, including: Bridge to Life, Healthtrackrx, Inventus Group.
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Financings for Sept. 23, 2025

Sep. 23, 2025
Med-tech firms raising money in public or private financings, including: Caregility, Pictor.
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In the clinic for Sept. 23, 2025

Sep. 23, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ultromics.
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Other news to note for Sept. 23, 2025

Sep. 23, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bracken, Caristo Diagnostics, Compass Bioinformatics, Epic, Genomenon, Labconnect, Myriad, Quest, Sophia Genetics.
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Regulatory actions for Sept. 23, 2025

Sep. 23, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bunkerhill Health, Cionic, Heartflow, Noul.
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Handshake, money, calculator, MA-letters

Biotech leaders: Macroeconomics, US policy shifts making M&A harder

Sep. 23, 2025
By Nuala Moran
No Comments
The unsettling impact that the Trump administration’s health care and tariff initiatives are having on M&A activity and financing is highlighted in a new survey of CEOs and investors, who say uncertainty related to the U.S. policy environment is the top challenge they face when it comes to executing deals.
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Illustration of damaged nerve cell and amyloid plaques
Biomarkers

pTau217 could change how Alzheimer’s is diagnosed

Sep. 23, 2025
By Mar de Miguel
No Comments
Experts agree that the earlier Alzheimer's disease is detected, the sooner action can be taken. And so, the key to preventing deterioration is identifying the most effective early biomarkers, those that can spot the disorder and help halt its progression. Recent advances in the field have pushed a new era of early detection through blood-based biomarkers and personalized medicine strategies based on each patient’s genetic, immunological and clinical profile.
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Transmission electron micrograph of HIV particles
HIV/AIDS

Deep dive nets sex differences in HIV reservoir

Sep. 23, 2025
By Anette Breindl
No Comments
Globally, over half of people living with HIV are women. But in clinical cure trials, they make up only about 20% of participants. And that gender imbalance is causing researchers to miss out on ways to improve cure strategies. Because women’s immune systems appear to be better at controlling HIV infection in a way that silences the reservoir – the provirus integrated into host cells in infected persons.
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