Approval/Clearance

Thrombectomy technology leader, Penumbra Inc. has secured CE Mark in Europe for the latest computer assisted vacuum thrombectomy (CAVT) devices.   Background … continue reading “Thrombectomy Specialist Penumbra’s Lightning Products CE Mark Makes Them Europe’s Only CAVT Systems “

Boston Scientific Corporation tells us it has obtained CE mark for the ACURATE Prime™ Aortic Valve System. Indeed it is … continue reading “ACURATE Prime™, Boston Scientific’s New Aortic Valve System 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”

Heart Valve Pioneer Foldax® Inc., will see its innovative TRIA™ polymer mitral surgical heart valves being manufactured in India. A newly … continue reading “Foldax Signs Indian Manufacturer to Help Expedite Mitral Valve Commercialization in the Country”

Scoliosis management has gained a new string to its bow in the United States. The FDA has cleared NSite Medical’s … continue reading “Scoliosis Management Boost as FDA Clears AI-Solution”

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”

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) have announced the U.S. … continue reading “FDA approves Recor Medical’s Paradise™ Ultrasound Renal Denervation for Hypertension”

Medtronic plc, has received U.S. FDA 510(k) clearance and Breakthrough Device designation for its novel LigaPASS™ 2.0 Ligament Augmentation System. … continue reading “FDA Clears First Spine Device for Ligament Augmentation”

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”

CVRx, Inc., developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure, has received U.S. … continue reading “CVRx®Barostim™ Heart Failure System Gains MR-Conditional Labeling Approval”

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™”

Wision A.I. Ltd. has announced the expansion of its product portfolio with recent U.S. FDA 510(k) Clearance for EndoScreener, its … continue reading “Wision A.I. Expands U.S. Offerings to Combat Colorectal Cancer With Multiple Screening Tools”

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”

ENT Endoscope specialist, 3NT Medical has gained FDA clearance for its Peregrine™ Drivable ENT Scope. Peregrine is designed to provide … continue reading “FDA Clearance for 3NT Peregrine™ Sinus Endoscope”

Cardiac and Vascular device developer Hancock Jaffe Laboratories, Inc., tells us that the U.S. FDA has granted Breakthrough Device Designation status to … continue reading “FDA Breakthrough Device Status for Hancock Jaffe VenoValve®”

Pain relief using implantable neurostimulation has come on a lot in recent times. For evidence, try searching our pages. Now … continue reading “Pain Relief Boost with Spinal Cord Stimulator Approval”