FDA expands BiVACOR artificial heart study after successful first implants
The US Food and Drug Administration (FDA) has approved the expansion of BiVACOR’s early feasibility study evaluating its titanium total…
Cardiovascular
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Abbott completes first-in-human leadless procedures with AVEIR system
Abbott has completed the first-in-human procedures for leadless left bundle branch area pacing (LBBAP) using its AVEIR conduction system pacing…
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HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance
HeartBeam has gained the US Food and Drug Administration's 510(k) clearance for its comprehensive arrhythmia assessment system. The patented high-fidelity…
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Sensome’s fresh clot detection system shows promise in PAD treatment studies
Sensome’s Clotild Smart Guidewire System has shown promise in identifying ‘fresh’ clots in individuals with peripheral artery disease (PAD) according…
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FDA grants PMA approval to J&J MedTech’s heart pumps for paediatric use
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Johnson & Johnson (J&J) MedTech’s Impella 5.5…
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Microbot Medical seeks FDA clearance for endovascular robotic system
Microbot Medical has submitted a 510(k) premarket notification for its disposable endovascular robotic system, LIBERTY, to the US Food and…
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NMPA approves Stereotaxis and MicroPort’s ablation catheter
China's National Medical Products Administration (NMPA) has granted regulatory approval to the ‘Magbot Magnetic Navigation Ablation Catheter’, a collaborative innovation…
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RenovoRx begins commercialisation of RenovoCath device
RenovoRx has begun commercialising its RenovoCath device after receiving the first purchase orders for the delivery platform, which was cleared…
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Inspira and Westchester Medical Center partner to assess ART100 systems
Inspira Technologies has announced a strategic partnership with Westchester Medical Center to assess the effectiveness and performance of its INSPIRA…
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Medtronic reports outcomes from aortic stenosis treatment study of TAVR system
Medtronic has reported new clinical data from the study of its Evolut transcatheter aortic valve replacement (TAVR) system, which is…
