Cardio

Biosensors International Group, Ltd. has announced the Japanese PMDA Approval for BioFreedom™ Ultra and US FDA Approval for BioFreedom™. Background … continue reading “Japanese PMDA Approval for BioFreedom™ Ultra and US FDA Approval for BioFreedom™”

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”

Vektor Medical, Inc. has gained U.S. FDA 510(k) clearance for its novel computational ECG mapping system, vMap™. The non-invasive technology … continue reading “vMAP™ Arrhythmia Hot Spot Detection System FDA Cleared”

Success for Penumbra Inc.’s Indigo® System CATTM RX Catheter in a newly reported study. The device met the primary endpoint and demonstrated high rates of blood clot … continue reading “Continuous Aspiration Thrombectomy with Penumbra Indigo® System CAT™RX Safe and Effective Says New Study”

Treatment supported by evidence from multiple studies and Renal Denervation Position Paper from the European Society of Hypertension Background It’s … continue reading “Renal Denervation Back in Europe with ReCor Paradise™ Launch”

Imagine four-dimensional (4D) imagery of the beating heart, viewed live, in 360°. Now add real-time tissue analysis to the same … continue reading “$17m New Finance for 4D Cardiac Imaging Tech”

The novel TRIA™ surgical aortic heart valve from Foldax®, Inc. has completed enrollment in its U.S. early feasibility study. Background Foldax … continue reading “Enrollment Complete in Tria™ Biopolymer Valve Study”

Based in Eindhoven, Netherlands, Xeltis is a clinical-stage developer of advanced polymer-based restorative cardiovascular devices. The company has now announced … continue reading “First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve”

Medtronic plc has announced the U.S. commercial launch of the Carpediem™ Cardio-Renal Pediatric Dialysis Emergency Machine, the first and only … continue reading “Carpediem™ First Cardio-Renal Pediatric Dialysis Launch”

Penumbra, Inc. has announced U.S. FDA 510(k) clearance for expanded indication of the Indigo® Aspiration System, Lightning™ 12. Background Pulmonary embolism, … continue reading “Penumbra’s Indigo® Cleared for Pulmonary Embolism”

Johnson & Johnson Medical Devices Companies’ Biosense Webster, Inc., says the first patients have been enrolled and treated in its … continue reading “First Patients in Europe Treated with Biosense Webster VARIPULSE® AF Catheter”

Johnson & Johnson Medical Devices Companies have announced the U.S. FDA approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH® SF Ablation … continue reading “FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation”

Cardiovascular regenerative therapies company BioCardia®, Inc., tells us it has resumed cases in the CardiAMP Heart Failure Trial. The first … continue reading “Cases Resume in BioCardia CardiAMP Heart Trial”

Respiratory Sleep Disorder specialist, Itamar Medical Ltd. has announced publication of results of the COMPASS study. The upshot sees validated … continue reading “First Scoring Guidelines Validated for WatchPAT™ Sleep Apnea Diagnostic”

BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, has announced the extension … continue reading “Revivent TC Less Invasive Ventricular Enhancement Therapy CE Mark Extended to 2024”