US-based electrocardiogram (ECG) company AccurKardia has received breakthrough designation from the US Food and Drug Administration (FDA) for its Aortic Valve Stenosis (AVS) ECG-based...
Health technology company Happy Health has received approval from the US Food and Drug Administration (FDA) for its Happy Ring, a clinical-grade wearable smart...
Corin received FDA 510(k) clearance for its Unity Knee medial constrained (MC) tibial insert. Cirencester, UK-based Corin designed the Unity Knee MC tibial insert...
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...
