Category: Clearances

Clearances

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.

Clearances

FDA OKs Sibel Health ANNE One Wearable for Adolescent Use

Sibel Health’s continuous wearable monitoring solution, ANNE One, received FDA clearance for use with adolescents 12 and older.

Clearances

STeP Program Accepts EndoQuest Flexible Robotic System

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.

Clearances

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.

Telesair Bonhawa High Flow Oxygen Therapy System Nabs FDA Clearance

Oct 18, 2023

The FDA has cleared Telesair’s Bonhawa High Flow Oxygen Therapy system, which is designed to enhance treatment of patients with respiratory insufficiency.

FDA Creates UV Microbial Reduction Device Category

Oct 11, 2023

The FDA created a new medical device category covering UV devices to microbial reduction, requiring authorization before coming to market.

HistoSonics Histotripsy Therapy Platform Hits FDA Milestone

Oct 9, 2023

The FDA granted clearance to HistoSonics Histotripsy therapy platform for non-invasive destruction of liver tumors using focused ultrasound.

Quanta Dialysis System Submitted to FDA for Clearance

Sep 28, 2023

Quanta Dialysis Technologies has submitted a 510(k) premarket notification to the FDA for indication expansion of the Quanta Dialysis System.

FDA Clears CorVista System With CAD Add-On

Sep 18, 2023

The FDA cleared the CorVista System with CAD Add-On to evaluate the presence of significant coronary artery disease as an aid in diagnosis.

FDA Clears Insight Medbotics MRI-Compatible Surgical Robot

Sep 13, 2023

Insight Medbotics has received U.S. FDA 510(k) clearance for its MRI-compatible IGAR robot for breast biopsy indications.

Clearances

Limaca Medical Precision GI Makes Second FDA Milestone

Limaca Medical's Precision GI Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the FDA.