Johnson & Johnson launched its latest pulsed field ablation (PFA) catheter, Varipulse Pro, in Europe following CE mark approval, bringing another option to electrophysiologists looking to adopt PFA technology. The system features a new pulse sequence with a lower temperature profile and enables ablation that is five times faster than the previous sequence, while achieving equivalent lesions. It represents another significant development in the rapidly evolving PFA market that has transformed cardiac ablation treatment.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Allevion, Regeneron, Stereotaxis.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Bioinsights, Denali, Immunitybio, Inspira, Nano Dimension, NEC Bio, Profusa, Takeda, Transgene.
Biopharma and med-tech companies raising money in public or private financings, including: Acurion, Beacon, Innocan, Opus, OS Therapies, Sharp, Syneron.
Total med-tech financings reached $8.54 billion in the first quarter (Q1) of 2026, reflecting a modest pullback from $9.33 billion in the same period of 2025 but remaining well above previous years. The Q1 2026 total exceeds the $6.45 billion recorded in Q1 2024 and $4.69 billion in Q1 2023, signaling continued recovery from the post-2021 downturn.
South Korea is rolling out regulatory changes to speed biosimilar development, including reforms to shorten review timelines, ease phase III trial requirements and simplify oversight of manufacturing changes.
Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP).
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