Regulatory Approvals

French MedTech Cardiawave has gained an EU CE mark for its non-invasive ultrasound therapy (NIUT) Valvosoft, marking the first device of its kind available...

Atraverse Medical announced that it received FDA clearance for its fully integrated Hotwire transseptal access system. Hotwire is a novel radiofrequency guidewire left-heart access device....

Francis Medical’s Vanquish device for treating intermediate-risk prostate cancer has been cleared by the US Food and Drug Administration (FDA). Vanquish is a transurethral, ultrasound...

Artiria Medical, a Swiss innovator in neurovascular technologies, proudly announces that its SmartGUIDE 014 deflectable guidewire, a next-generation guidewire specifically developed for neurovascular interventions,...

2z Radiology AI has secured approval from the US Food and Drug Administration (FDA) for its a2z-Unified-Triage, a multi-condition triage system for abdomen-pelvis CT...

Ligence announces that its AI-powered echocardiography software, Ligence Heart, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. Ligence Heart, is an AI-powered...

iCardio.ai announces FDA 510(k) Clearance for CardioVision. This is the company’s second FDA clearance. CardioVision can automatically detect aortic stenosis, a disease affecting 1.5M Americans...

CeriBell announced that it received FDA 510(k) clearance for its next-generation Clarity algorithm. The new algorithm detects electrographic seizures in newborns pre-term and older. Clearance...

QuantalX Neuroscience’s Delphi-MD, a device to monitor and evaluate brain health, has gained de novo classification from the US Food and Drug Administration (FDA),...