SyntheticMR announced today that its next-generation 3D imaging solution with isotropic resolution received FDA 510(k) clearance.Linköping, Sweden-based SyntheticMR said in a news release that...
Italian medical device company Endostart has secured US Food and Drug Administration (FDA) 510(k) clearance for its colonoscopy device, which is designed to optimise...
Calyxo announced today that it received FDA clearance for its new, redesigned CVAC system for minimally invasive kidney stone treatment.Pleasanton, California–based Calyxo’s CVAC system...
Neuronetics announced that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as...
Health Canada has granted approval of the Eye-Tracking Neurological Assessment for Multiple Sclerosis (ETNA™-MS). Developed by Innodem Neurosciences (Innodem), ETNA™-MS is a software as...
US-based medical equipment manufacturer RedDrop Dx has received the US Food and Drug Administration (FDA) 510(k) approval for its advanced blood collection device, RedDrop...
Elixir Medical today announced it received FDA breakthrough device designation for its DynamX BTK system for treating chronic limb-threatening ischemia. The Milpitas, California-based company...
Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system.The company obtained European Union Medical Device Regulation...
