Cardiovascular

Simpson secures FDA breakthrough device designation for Acolyte system

The US Food and Drug and Administration (FDA) has granted breakthrough device designation to Simpson Intervention’s Acolyte Image Guided Crossing…

ACC24: V-Wave interatrial shunt misses primary endpoint

US-based medical device company V-Wave released primary data from the RELIEVE-HF pivotal trial of its Ventura interatrial shunt. The randomised…

J&J seeks cardiovascular market growth with $13.1bn Shockwave deal

Johnson & Johnson (J&J) has agreed to acquire US-based cardiovascular device developer Shockwave Medical in one of the biggest medtech…

GE HealthCare adds Caption AI to Vscan Air SL for cardiac imaging

GE HealthCare has announced the integration of Caption AI technology with Vscan Air SL wireless handheld ultrasound system, aimed at…

Kardium’s pulsed field ablation clinical trial enters final stages

Kardium has completed enrolment in a study evaluating its pulsed-field ablation (PFA) device for the treatment of atrial fibrillation. According…

FDA approves Abbott’s TriClip system for tricuspid valve repair

The US Food and Drug Administration (FDA) has granted approval for Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system for leaky…

Protembis enrols first patient for ProtEmbo System trial

German cardiovascular medical device company Protembis has enrolled the first patient in its PROTEMBO investigational device exemption (IDE) pivotal trial…

Concept wins another IDE from FDA for MagicTouch range

The US Food and Drug Administration (FDA) has granted Concept Medical an investigational device exemption (IDE) for its MagicTouch arteriovenous…

Sequana’s DSR therapy shows promise in heart failure patients

Belgium-based Sequana Medical has released data from the Phase I/II MOJAVE study in the US, which is evaluating its direct…

PulseCath lands CE mark for mechanical circulatory support device

Netherlands-based PulseCath has received a CE mark under the EU Medical Device Regulation (MDR) for its mechanical circulatory support device,…

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