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BioWorld - Tuesday, July 28, 2026
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Regulatory actions for April 16, 2025

April 16, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Augurex, Luma Vision, Nanospeed Diagnostics, Native Orthopaedic.
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Illustration of human brain and dna
Neurology/psychiatric

Commander proteins linked to lysosomal dysfunction in Parkinson’s

April 16, 2025
By Mar de Miguel
Genes associated with lysosomal dysfunction increase the risk of Parkinson’s disease (PD), according to a study led by scientists at Northwestern University. The discovery also explains why some people who carry a pathogenic variant of the GBA1 gene develop PD or dementia with Lewy bodies (DLB) and others do not. The key lies in the Commander complex, involved in the transport of proteins to this organelle. This discovery raises the need for combinatorial therapies that act on more than one pathway for this type of neurodegenerative disorder.
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Map of Europe, Medical Device Regulation (MDR) text

Elixir granted CE mark for Lithix IVL

April 15, 2025
By Annette Boyle
Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany.
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Microchip robotic manufacturing concept

Impact of tariffs on supplies of semiconductor tough to calculate

April 15, 2025
By Mark McCarty
The Trump administration sent several signals about the imposition of tariffs on semiconductors – a vital component for many devices. While imaging systems sell infrequently and may not suffer from a short-term crimp in supplies of semiconductors, items such as pacemakers sell by the hundreds of thousands each year in the U.S. a fact that makes semiconductor products a crucial component of the well-being of millions of Americans.
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Da Vinci Xi robot - Intuitive Surgical

J&J reports completion of first cases with Ottava robotic system

April 15, 2025
By Holland Johnson
Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic surgical system. The cases mark the first clinical experience with the Ottava system, which has been a long time in development.
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CMS logo and website

CMMI again under pressure as CMS closes several programs

April 15, 2025
By Mark McCarty
The Center for Medicare and Medicaid Innovation was founded with the objective of reducing Medicare spending, but many of the associated programs will be stood down by the end of this year thanks in part to a 2023 report detailing a significant increase, rather than a decrease, in spending associated with CMMI programs.
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Appointments and advancements for April 15, 2025

April 15, 2025
New hires and promotions in the med-tech industry, including: Instylla, Parexel, Turing Medical.
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Financings for April 15, 2025

April 15, 2025
Med-tech firms raising money in public or private financings, including: Bioporto, Conavi, Phantom Neuro.
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In the clinic for April 15, 2025

April 15, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ossdsign, Spinex.
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Other news to note for April 15, 2025

April 15, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bristol Myers Squibb, Illumina, Imperative, Optellum, Nanowear, Satio, Tempus.
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