Regulatory Approvals

OrthAlign has expanded its portfolio of Lantern handheld navigation systems by securing a 510(k) clearance from the US Food and Drug Administration (FDA) for...

Zurich-based nuclear medical imaging device firm Positrigo’s positron emission tomography (PET) system, NeuroLF, has acquired market authorisation from the European Union (EU). The ultra-compact diagnostic...

BioIntelliSense has received approval from the US Food and Drug Administration (FDA) for its BioButton Multi-Patient wearable and BioDashboard system for continuous patient monitoring. The...

PlaqueIQ is a non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, and is designed to give physicians new,...

Surmodics received FDA 510(k) clearance for its Pounce XL thrombectomy system. The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli...

Pi-Cardia announced the FDA granted clearance for its ShortCut leaflet modification device for TAVR procedures. Rehovot, Israel-based Pi-Cardia designed ShortCut to split the leaflets...

Robotic mobility and humanoid technology company Human in Motion Robotics has received regulatory approval to market and sell the XoMotion exoskeleton in Canada. It is...

Nevro received FDA approval for an AI-powered, personalised pain management platform for spinal cord stimulation. HFX AdaptivAI, a responsive, personalised pain management platform, powers...

The US Food and Drug Administration (FDA) has granted approval for Alpha Tau Medical’s investigational device exemption (IDE) application to initiate a study of...