Regulatory Approvals

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),...

Paradromics received FDA investigational device exemption (IDE) to begin a study of its brain-computer interface (BCI). The FDA nod enables the company to start...