FDA Clears Epitel’s REMI Technologies for EEG Monitoring
Epitel announced FDA clearance for two technologies: REMI Remote EEG Monitoring System for home use and REMI Vigilenz AI for Event Detection.
Epitel announced FDA clearance for two technologies: REMI Remote EEG Monitoring System for home use and REMI Vigilenz AI for Event Detection.
Sibel Health’s continuous wearable monitoring solution, ANNE One, received FDA clearance for use with adolescents 12 and older.
EndoQuest Robotics' Flexible Robotic System has been accepted into the U.S. FDA's Safer Technologies Program (STeP), allowing for a streamlined development process aimed at enhancing medical treatment safety. The company plans to collaborate further to advance its endoluminal robotic system for minimally invasive surgery.
Epitel announced FDA clearance for two technologies: REMI Remote EEG Monitoring System for home use and REMI Vigilenz AI for Event Detection.
The FDA has cleared Telesair’s Bonhawa High Flow Oxygen Therapy system, which is designed to enhance treatment of patients with respiratory insufficiency.
Read MoreThe FDA created a new medical device category covering UV devices to microbial reduction, requiring authorization before coming to market.
Read MoreThe FDA granted clearance to HistoSonics Histotripsy therapy platform for non-invasive destruction of liver tumors using focused ultrasound.
Read MoreQuanta Dialysis Technologies has submitted a 510(k) premarket notification to the FDA for indication expansion of the Quanta Dialysis System.
Read MoreThe FDA cleared the CorVista System with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis.
Read MoreInsight Medbotics has received U.S. FDA 510(k) clearance for its MRI-compatible IGAR robot for breast biopsy indications.
Read MoreLimaca Medical's Precision GI Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the FDA.