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Phagenesis gets FDA breakthrough device status for neurostimulation device

Phagenesis has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Phagenyx system. Phagenyx is…

Medtronic gets CE mark for InterStim Micro and SureScan MRI leads

Irish medical technology firm Medtronic has secured CE mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.…

TriSalus Life Sciences introduces new TriNav infusion system

TriSalus Life Sciences has introduced a new TriNav infusion system, which has been developed to overcome infusion barriers within solid…

Guardant Health, NRG Oncology to validate use of MRD assay in colon cancer trial

Guardant Health and NRG Oncology have commenced a randomised trial to validate the clinical use of Guardant Health’s molecular residual…

Teladoc Health to buy telehealth services firm InTouch Health for $600m

Teladoc Health has agreed to acquire enterprise telehealth solutions provider InTouch Health in a deal valued at around $600m. The…

Todos Medical to buy in vitro diagnostics company Provista Diagnostics

Todos Medical has agreed to acquire in vitro diagnostics company Provista Diagnostics for an undisclosed sum. Provista is involved in…

Reflow Medical gets FDA breakthrough device status for Temporary Spur Stent System

Reflow Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Temporary Spur Stent…

JenaValve TAVR system designated by FDA as breakthrough device

JenaValve Technology, developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic…

Alucent Biomedical announces FDA approval to proceed with Natural Vascular Scaffolding clinical trial

Alucent Biomedical has received U.S. Food and Drug Administration approval to proceed with a Phase 1 clinical trial to evaluate…

Abionic integrates first patients in US clinical trial for sepsis diagnosis method

Abionic SA, Swiss Medtech firm based in Lausanne, is initiating a pivotal clinical trial in the US for an innovative…