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 replacement system.…
23 Dec 2025
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 Regulation (EU MDR). The US company’s embolisation plugs…
23 Dec 2025
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-based laboratories, for a combined purchase price of around $55.5m. Closure of…
23 Dec 2025
FDA approves Abbott’s Volt PFA system for atrial fibrillation
The US Food and Drug Administration (FDA) has granted approval for Abbott’s Volt PFA System, expanding treatment options for patients with atrial fibrillation (AFib). The approval follows earlier CE Mark…
22 Dec 2025
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 processing technology, Neurable AI, which integrates brain-computer interface (BCI) offerings into commonly…
22 Dec 2025
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 defibrillator (WCD) in the US. The latest device is the fifth LifeVest WCD, which secured…
19 Dec 2025
CellBxHealth’s new CEO pivots strategy amid financial turnaround efforts
CellBxHealth’s CEO Peter Collins has explained plans to restructure the company following its rebrand from ANGLE in October. The company had struggled with sinking profits and evaporating investor confidence, causing…