Clinical Studies/Trials

New funding will be used to support Jupiter Endovascular in its upcoming pivotal trial for Pulmonary Embolism. It will also … continue reading “Jupiter Endovascular Funding Means Green Light for Pulmonary Embolism Pivotal Trial”

The Emboliner “Protect the Head to Head” investigational device exemption (IDE) clinical trial has seen its one hundredth patient enrolled. … continue reading “Emboliner ® IDE Study 100 Patient Milestone”

Biosense Webster, Inc., has announced European CE mark approval of the VARIPULSE™ Platform. The approval covers the treatment of symptomatic drug refractory … continue reading “VARIPULSE™ Pulse Field Ablation (PFA) Platform Gains CE Mark”

Cognito Therapeutics has announced publication of MRI imaging data from its Phase 2 OVERTURE study in the Journal of Alzheimer’s Disease … continue reading “Alzheimer’s Cognito Sensory Stimulation Study Promise”

Netherlands and US-based medtech company Xeltis tells us about its first-in-human (FIH) vascular conduit trial for hemodialysis access. Vascular surgeon … continue reading “Hemodialysis Access Promise from Polymer Implant”

Vivos Therapeutics, Inc. says its removable CARE (Complete Airway Repositioning and/or Expansion) oral appliance has been granted U. S. FDA … continue reading “Severe Sleep Apnea “Game-Changing” FDA Clearance”

Medtronic plc says the US FDA has approved the Symplicity Spyral ™ renal denervation (RDN) system as an adjunct to … continue reading “Spyral ™ Gains FDA Approval”

The first US patient has been enrolled at Medstar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to … continue reading “SELUTION SLR Coronary Sirolimus DEB Study: First US Patient Enrolled”

CairnSurgical, Inc., an innovator striving to make breast cancer surgery more precise, has announced that the first patients have been … continue reading “Breast Cancer EU Study Patients for CairnSurgical BCLTM System”

Envoy Medical® Corporation tells us the first patient has been enrolled and implanted in the Acclaim® Cochlear Implant early feasibility … continue reading “First Patient Receives Fully Implanted Acclaim® Cochlear Implant in Envoy Medical Early Feasibility Study”

Swiss company Argá Medtech has begun enrollment in a First-in-Human Clinical Trial of its CSE Ablation System in the treatment … continue reading “First-in-Human Trial will Assess the Safety and Effectiveness of Coherent Sine Wave Electroporation in Patients with Atrial Fibrillation”

MedAlliance’s SELUTION SLR™ drug-eluting balloon (DEB) has received FDA Investigational Device Exemption (IDE) approval, making it the first limus DEB … continue reading “First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval”

Foldax®, Inc. says the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of … continue reading “First O.U.S. Patients Get TRIA Biopolymer Surgical Aortic Valve™”

Argá Medtech’s next-generation non-thermal cardiac ablation system shows promise in improving precision, speed and flexibility in treating atrial fibrillation, says … continue reading “Study Shows Promise for Next-Generation Cardiac Ablation Tech”

A newly published global multicenter study demonstrates the effectiveness of the Broncus Medical, Inc. Archimedes Virtual Bronchoscopic Navigation (VBN) System … continue reading “Archimedes Effective in Guiding Sampling of Cancerous Peripheral Lung Lesions”

Medtronic plc says the first patient implants in the TITAN 2 pivotal study will evaluate the safety and efficacy of … continue reading “Tibial Neuromodulation for OAB: First Patient Implants”