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BioWorld - Tuesday, December 23, 2025
Breaking News: BioWorld 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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Notice of email fulfillment change

Dec. 23, 2025
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Effective Jan. 5, 2026, BioWorld is switching email fulfillment services. While we have made every effort to ensure that all current user subscription details — as well as information on users who have unsubscribed — have been migrated accurately to the new system, there may be a few instances where certain information may not have carried over as expected. If you have any concerns that you received a newsletter in error or if a colleague has not received an expected newsletter, do not hesitate to reach out to our customer care team. You can submit a query. Or call us:

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India map on technology concept background

Bayosthiti AI to build India-specific RNA sequencing ecosystem

Dec. 23, 2025
By Marian (YoonJee) Chu
Bayosthiti AI Pvt Ltd. aims to make RNA sequencing and AI-based preventive health care affordable and accessible for the Indian market, leveraging intellectual property from its parent company, Biostate AI Inc.
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Med-tech gainers and losers for Dec. 15-19, 2025

Dec. 22, 2025
The top 10 med-tech stock gainers and losers for the week.
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Abbott Labs Volt

A pleasant shock: Abbott’s Volt PFA system snags early FDA approval

Dec. 22, 2025
By Annette Boyle
Two years after the U.S. FDA approved the first pulsed field ablation system, Abbott Laboratories finally got the regulatory nod for its Volt PFA system. Abbott follows Medtronic plc, Boston Scientific Corp., Johnson & Johnson and Kardium Inc. in receiving approval for its approval for use of its PFA device to treat atrial fibrillation.
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EU flags
The year in review

EU scrambled in 2025 to overcome problems with AI Act, device regs

Dec. 22, 2025
By Mark McCarty
The year 2025 will go down in med-tech history as remarkable for a number of things, but manufacturers doing business in the EU might be forgiven for thinking that it was a year for correction of self-inflicted wounds, even if those corrections won’t arrive in full form until 2026.
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Medicare puzzle

MAC attack on CPT code for hypoglossal nerve stimulation dings Inspire

Dec. 22, 2025
By Mark McCarty
Two U.S. Medicare administrative contractors (MACs) have removed CPT code 6468 from their group 1 CPT codes, a move that may cut rates for implant of Inspire Medical Inc.'s flagship product, the Inspire hypoglossal nerve stimulator for treatment of obstructive sleep apnea.
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Tau protein in Alzheimer's disease

Quanterix assay helps shed light on Alzheimer’s prevalence

Dec. 22, 2025
Quanterix Corp. reported the publication of a landmark study in Nature which utilized its Simoa p-Tau 217 (phosphorylated tau at threonine 217) research assay. The Nature study is the largest population-based assessment of Alzheimer’s Disease Neuropathological Changes to date, providing crucial, scalable data to redefine disease prevalence it said.
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Appointments and advancements for Dec. 22, 2025

Dec. 22, 2025
New hires and promotions in the med-tech industry, including: Adagio Medical, Lifeward.
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Other news to note for Dec. 22, 2025

Dec. 22, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcon, Brainsway, Ion Beam Applications, Optum, ORA, Staar Surgical.
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Regulatory actions for Dec. 22, 2025

Dec. 22, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Shape Memory Medical.
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