Products

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”

CVRx, Inc., developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its … continue reading “Neuromodulation specialist CVRx Launches new Barostim NEO2™ Implantable Pulse Generator”

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™”

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™”

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”

Miach Orthopaedics, Inc., tells us its the BEAR® Implant is now commercially available in select U.S. cities. BEAR is designed … continue reading “BEAR® ACL Implant Launches in U.S.”

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”

Advanced 3D technology will enable host institutions to enjoy the benefits of having an ‘in-house’ virtual and 3D printed facility. … continue reading “3D LifePrints Medical 3D Printing Service for USA”

PolyNovo UK Ltd officially launch its NovoSorb® BTM synthetic dermal scaffold at MEDICA 2021 in November. Background Surgical and traumatic … continue reading “NovoSorb® BTM Synthetic Wound Matrix Launches at MEDICA”

As the world battles a global respiratory disease, Armstrong Medical will be launching its new AquaVENT® VT heated ventilator breathing circuits … continue reading “Armstrong Medical to Launch AquaVENT® VT Heated Ventilator Circuits at MEDICA 2021”

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®”

Ear, nose and throat (ENT) specialist company Intersect ENT®, Inc., has announced the U.S. nationwide commercial availability of the VenSure™ … continue reading “Intersect ENT Launches VenSure Balloon Sinus Dilation and Cube Navigation System”