Toku bags breakthrough designation for kidney disease eye scan device
California-based Toku has seen its artificial intelligence (AI) system for identifying kidney disease awarded the US Food and Drug Administration …
Veris teams up with Ohio University for cancer digital health pilot
PAVmed’s digital health subsidiary Veris Health and the Ohio State University Comprehensive Cancer Center – Arthur G James Cancer Hospital …
South Korea’s Medit launches i900 intraoral scanner worldwide
South Korean dental 3D scanners and digital dentistry solutions provider Medit has globally launched the Medit i900 intraoral scanner, designed …
Soterix Medical introduces electrical stimulation and EEG system
Soterix Medical has announced the launch of the MxN-GO EEG system that integrates high-definition transcranial electrical stimulation (HD-tES) with EEG …
Senseonics’ Eversense system earns iCGM designation from FDA
Senseonics, in collaboration with Ascensia Diabetes Care, has announced that its Eversense product received an integrated continuous glucose monitoring (iCGM) …
Magnus Medical rolls out neuromodulation system in US
Magnus Medical has announced the commercial launch of its SAINT neuromodulation system in the US, a new therapy designed to …
Explainer: UK election 2024 – healthcare outlook
The United Kingdom is staring down the prospect of a general election, set to take place at some stage in …
Neuromodulation to see market growth, pioneering technology for epilepsy
Epilepsy is a neurological disorder that is characterised by recurrent seizures and affects about 50 million people worldwide. While pharmaceuticals …
Sight Sciences awarded $34m in Alcon patent infringement case
Sight Sciences has announced a positive trial verdict in a $34m patent infringement case against Alcon and its minimally invasive …
FDA approves Labcorp companion diagnostic for Pfizer gene therapy
The US Food and Drug Administration (FDA) has approved Labcorp’s nAbCyte Anti-AAVRh74var HB-FE assay as a companion diagnostic to Pfizer’s …
Artivion presents double win at AATS for aortic devices
Artivion has presented new clinical data from two trials, one demonstrating better patient outcomes when using its On-X aortic valve, …
GE HealthCare’s new vital signs monitor receives FDA 510(k) clearance
GE HealthCare has announced that its Portrait vital signs monitor (VSM) received 510(k) clearance from the US Food and Drug …
Neurosoft’s Dr Nicolas Vachicouras on the evolution of neurological rehabilitation
Traditional methods of neurological rehabilitation for those who have suffered a stroke or spinal cord injury and lost movement in …
Smart Blood Analytics gains EU certification for clinical software
Smart Blood Analytics Swiss has secured the European Medical Device Regulation (EU-MDR) certification for its VIRUS versus BACTERIA Clinical Decision …
FDA issues final rule regulating LDTs as medical devices
The US Food and Drug Administration (FDA) has issued its Final Rule in officially making explicit that In Vitro diagnostic …