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BioWorld - Sunday, February 8, 2026
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Regulatory actions for Dec. 16, 2025

Dec. 16, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Bluewind Medical, May Health, Medivis, MPM Medical, Roche, Zephyrus.
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Med-tech gainers and losers for Dec. 8-12, 2025

Dec. 15, 2025
The top 10 med-tech stock gainers and losers for the week.
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Lock on digital globe illustration

US Biosecure Act a vote away from law

Dec. 15, 2025
By Mari Serebrov
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“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
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Nephrodite Holly

Nephrodite's Holly renal replacement named breakthrough device

Dec. 15, 2025
By Annette Boyle
Nephrodite Inc.'s Holly, an implantable, continuous renal replacement system, received U.S. FDA breakthrough device designation as a novel and potentially life-changing treatment for end-stage kidney disease. The system is designed to enable continuous blood filtration and allow patients freedom to go about their days without frequent, hours-long visits to a dialysis clinic or being hooked up to a filtration system at home.
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Illustration of human anatomy, enlarged prostate

Proverum, Zenflow secure FDA nod for systems to treat BPH

Dec. 15, 2025
By Shani Alexander
The U.S. FDA recently cleared two new medical devices to treat benign prostatic hyperplasia, offering men with enlarged prostates additional treatment options which are minimally invasive. The approvals include Proverum Medical Ltd.’s Provee System and Zenflow Inc.’s Zenflow Spring Implant and Delivery System, both are first-line interventional therapeutic options which offer relief to the millions of men living with the condition.
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Appointments and advancements for Dec. 15, 2025

Dec. 15, 2025
New hires and promotions in the med-tech industry, including: Envue Medical.
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Financings for Dec. 15, 2025

Dec. 15, 2025
Med-tech firms raising money in public or private financings, including: Inspira Technologies, Impulse Dynamics.
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In the clinic for Dec. 15, 2025

Dec. 15, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Radiopharm Theranostics.
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Other news to note for Dec. 15, 2025

Dec. 15, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioretec, Heartsciences, Helio Genomics, Lunit, Natera, Neogenomics, Neurosigma, Philips, Spectrawave.
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Regulatory actions for Dec. 15, 2025

Dec. 15, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Companion Spine, Hyperfine.
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