Is your quality system built for 2026’s new regulatory reality?
The life sciences industry has always operated under pressure to stay ahead of regulatory change. But 2026 has raised the …
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HistoSonics’ Edison histotripsy system obtains CE mark
HistoSonics has secured a European CE mark for its histotripsy system Edison, setting the stage for the device’s commercialisation across …
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FDA clears Zeta Surgical’s robotic TMS navigation system
Zeta Surgical’s transcranial magnetic stimulation (TMS) robotic navigation system, designed to make delivering the treatment modality in treatment-resistant depression (TRD) …
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En Carta secures $6.18m to expand molecular testing solutions
French deep-tech company En Carta Diagnostics has announced the first closing of €5m ($6.18m) in financing to scale its at-home …
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Virax Biolabs enters immune profiling product supply deal with Fosun
Virax Biolabs Group subsidiary Virax Biolabs (UK) has signed an exclusive commercial supply agreement with Fosun Diagnostics for its research-use-only …
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Otsuka ICU Medical outlays $500m to expand US manufacturing footprint
Otsuka ICU Medical is investing $500m into expanding its US-based IV manufacturing provision to improve long-term supply resiliency. The company, established …
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FDA clears iHealthScreen’s AI diabetic retinopathy screening software
Software as a Medical Device (SaMD) developer iHealthScreen has obtained US Food and Drug Administration (FDA) clearance for iPredict-DR, an artificial …
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Roche secures CE Mark for Elecsys test to detect tuberculosis
Roche has secured the CE Mark for its Elecsys Interferon Gamma Release Assay (IGRA) TB blood-based test designed to detect …
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TRiCares begins US IDE pivotal trial of TTVR system
TRiCares SAS has enrolled and treated the first patient in its TRICURE US IDE pivotal study of the Topaz transcatheter …
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GE HealthCare and Mayo Clinic partner for new theranostics research study
GE HealthCare and Mayo Clinic are establishing a new research collaboration to advance personalised approaches to radioligand therapy (RLT) for …
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Leo Cancer Care raises $65m for upright radiotherapy platform
Leo Cancer Care has raised $65m to advance manufacturing and commercial deployment activities surrounding its upright radiotherapy platform. The company’s oversubscribed …
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Johnson & Johnson’s DE STSF platform secures FDA approval
Johnson & Johnson (J&J) has secured approval from the US Food and Drug Administration (FDA) for its Dual Energy Thermocool …
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Philips expands ultrasound portfolio with AI-driven Alturion
Philips has expanded its ultrasound portfolio with the launch of the Alturion system, which features AI-powered workflows and is intended …
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Resmed sharpens sleep care focus with $490m software business sale
Resmed has agreed to sell its MatrixCare business in a $490m cash deal to PE firm Frazier Healthcare Partners, allowing …
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Ottobock expands neuro-orthotics portfolio with Fesia Technology acquisition
Ottobock has agreed to acquire Spanish medical device company Fesia Technology in a strategic move to expand its neuro-orthotics portfolio …
