Medical Device Network

Edwards receives FDA approval for mitral valve replacement system

Edwards Lifesciences has received the US Food and Drug Administration (FDA) approval for its SAPIEN M3 mitral valve ...
Medical Device Network

Shape Memory Medical’s embolisation plugs gain CE mark under EU MDR

Shape Memory Medical’s IMPEDE embolisation plug range has received CE mark as a Class III device under the European Union’s ...
Medical Device Network

Fulgent Genetics to buy Bako Diagnostics assets and StrataDx

Fulgent Genetics has signed a definitive agreement to buy specific assets of Bako Diagnostics and to acquire StrataDx, two US ...
Medical Device Network

ZOLL introduces next-gen wearable cardioverter defibrillator in US

Medical devices and related software solutions maker ZOLL has introduced its next-generation LifeVest wearable cardioverter ...
Medical Device Network

Neurable secures $35m to expedite BCI technology commercialisation

Neurable has completed a $35m Series A funding round to expedite the commercialisation of its patented compact brain-signal ...
Medical Device Network

FDA approves Abbott’s Volt PFA system for atrial fibrillation

Abbott’s VOLT-AF IDE trial enrolled 392 patients and was conducted across 40 centres in Australia, Canada, Europe, and the US. Credit: JarTee/Shutterstock.com. The US Food and Drug Administration (FDA ...