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BioWorld - Monday, December 29, 2025
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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Regulatory actions for Sept. 18, 2025

Sep. 18, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Brainlab, Ruthless Spine.
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Globe showing Asia-Pacific region
Asia Bio 2025

Piecing mosaic of APAC regulations key to Asia biotech growth

Sep. 18, 2025
By Marian (YoonJee) Chu
No Comments
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
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Roche Accu-Chek

Roche gets CE mark for CGM, Mysugr integration

Sep. 17, 2025
By Shani Alexander
Roche Holdings AG received CE mark approval for the integration of its AI-enabled continuous glucose monitoring system, Accu-Chek Smartguide, with the Mysugr diabetes management app. The integrated solution, which combines predictive CGM technology with therapy data in one place, will simplify the daily decision-making for users managing their diabetes.
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3D map of China
Asia-Pacific in the spotlight

China a great AI med-tech market, but premarket review unpredictable

Sep. 17, 2025
By Mark McCarty
China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.
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Eversense 365

Senseonics reclaims Eversense 365 distribution from Ascensia

Sep. 17, 2025
By Annette Boyle
After a five-year partnership, Senseonics Holdings Inc. and Ascensia Diabetes Care Holdings AG, a unit of Tokyo-based PHC Holdings Corp., agreed to transition worldwide commercialization and distribution of Senseonics’ Eversense 365 implantable continuous glucose monitor back to Senseonics beginning on Jan. 1, 2026.
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Gastric Alimetry

Alimetry brings first wearable gut diagnostic to market

Sep. 17, 2025
By Tamra Sami
Alimetry Ltd. is making waves far beyond its home market with its first-in-class wearable Gastric Alimetry device that measures gut function – an area long considered a black box in gastroenterology.
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Appointments and advancements for Sept. 17, 2025

Sep. 17, 2025
New hires and promotions in the med-tech industry, including: Cirtec Medical, InspireMD, Kestra Medical.
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Financings for Sept. 17, 2025

Sep. 17, 2025
Med-tech firms raising money in public or private financings, including: Bionano Genomics, Microbot Medical, Nanovibronix, Peerbridge Health.
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In the clinic for Sept. 17, 2025

Sep. 17, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Elutia, Materna, Immunexpress, Real Heart, Wat Medical.
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Regulatory actions for Sept. 17, 2025

Sep. 17, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amber Impants, Roche.
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