Scientists have developed a wearable ‘sticker’ that can accurately monitor and detect changes in breathing. They believe the ‘groundbreaking’ device … continue reading “First-of-its-kind ‘Sticker’ Monitors Breathing”
Clinical Studies/Trials
Boston Scientific to Acquire Atrial Fibrillation Tech Company Cortex, Inc.
Boston Scientific says its acquisition of Cortex, Inc., will complement electrophysiology portfolio with solution to advance the treatment of complex … continue reading “Boston Scientific to Acquire Atrial Fibrillation Tech Company Cortex, Inc.”
Valvosoft Non-Invasive Aortic Stenosis Therapy: Pivotal Study Results Promising
Cardiawave SA is the developer of the Valvosoft Non-Invasive Ultrasound Therapy (NIUT) device for the treatment of severe symptomatic calcific … continue reading “Valvosoft Non-Invasive Aortic Stenosis Therapy: Pivotal Study Results Promising”
Sensome Real-time, in situ Lung Tumor Confirmation System Study Enrols First Patients
French microsensing technology pioneer, Sensome has announced that the first eight patients have been enrolled in the first-in-human INSPECT study … continue reading “Sensome Real-time, in situ Lung Tumor Confirmation System Study Enrols First Patients”
Jupiter Endovascular Funding Means Green Light for Pulmonary Embolism Pivotal Trial
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”
Emboliner ® IDE Study 100 Patient Milestone
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”
VARIPULSE™ Pulse Field Ablation (PFA) Platform Gains CE Mark
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”
Alzheimer’s Cognito Sensory Stimulation Study Promise
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”
Hemodialysis Access Promise from Polymer Implant
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”
Severe Sleep Apnea “Game-Changing” FDA Clearance
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”
Spyral ™ Gains FDA Approval
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”
SELUTION SLR Coronary Sirolimus DEB Study: First US Patient Enrolled
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”
Breast Cancer EU Study Patients for CairnSurgical BCLTM System
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”
First Patient Receives Fully Implanted Acclaim® Cochlear Implant in Envoy Medical Early Feasibility Study
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”
First-in-Human Trial will Assess the Safety and Effectiveness of Coherent Sine Wave Electroporation in Patients with Atrial Fibrillation
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”
First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval
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”