XACT Robotics™ Ltd. tells us that its first robotic system has been cleared to market in the U.S. for use during … continue reading “XACT Robotic System Cleared by FDA for Percutaneous Interventional Procedures”
Approval/Clearance
CE Mark for Boston Scientific’s VERCISE™ Neural Navigator 3 Programming Software
Boston Scientific Corporation has announced the CE Mark approval of its Vercise™ Neural Navigator 3 directional Deep Brain Stimulation (DBS) programming … continue reading “CE Mark for Boston Scientific’s VERCISE™ Neural Navigator 3 Programming Software”
FDA Breakthrough Device Designation for SoniVie’s TIVUS Pulmonary Arterial Hypertension System
Pulmonary Arterial Hypertension (PAH) treatment specialist SoniVie, has been granted Breakthrough Device Designation from the U.S. FDA for the Therapeutic … continue reading “FDA Breakthrough Device Designation for SoniVie’s TIVUS Pulmonary Arterial Hypertension System”
CE Mark for Orchestra BioMed BackBeat Cardiac Neuromodulation Therapy™ for Hypertension
Orchestra BioMed™, Inc., tells us it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat … continue reading “CE Mark for Orchestra BioMed BackBeat Cardiac Neuromodulation Therapy™ for Hypertension”
U.S. Approval for Next-Generation MitraClip®
Abbott tells us it has received U.S. FDA approval for the fourth generation of of its MitraClip™ heart valve repair device to treat … continue reading “U.S. Approval for Next-Generation MitraClip®”
FDA Clearance for eon™ FR, Non-Contact Body Sculpting
Dominion Aesthetic Technologies, Inc. has received U.S FDA clearance for its body contouring product, eon™ FR, a non-contact medical device that that … continue reading “FDA Clearance for eon™ FR, Non-Contact Body Sculpting”
FDA Clearance of Steerable Introducer for Transseptal Access/Delivery
BioCardia shows its newly cleared transseptal access system at Heart Rhythm Society congress in San Francisco
COPD: FDA Breakthrough Device Designation for CSA Medical RejuvenAir® System
The RejuvenAir® System has been designated as a Breakthrough Device by the U.S. FDA. The company has also received unconditional IDE approval to initiate a pivotal clinical study.
U.S. FDA Clearance for Retia Medical’s Argos Cardiac Output Patient Monitor
The link between hemodynamic monitoring and improved clinical outcome is well established. Retia Medical says its newly cleared Argos cardiac output monitor brings with it a new level of accuracy
FDA Clears Vitamin E Highly Cross-Linked Polyethylene Hip Liner
E-XPE™ designed to provide wear resistance with reduced risk of oxidation: Now available in both knee inserts and hip liners
FDA Clears Eximo Medical B-Laser™ Atherectomy System for Peripheral Artery Disease
Eximo Medical Ltd. says it has received U.S. FDA 510(k) clearance for its B-Laser™ Atherectomy System for Peripheral Artery Disease (PAD)
Clearance and Launch for Mentor’s CPX4 Smooth Breast Tissue Expander
New tissue expander with smooth surface aids insertion and removal in breast reconstruction surgery
FDA Clearance Expands Scalp Cooler Indication
Experts welcome expansion of indication to include solid tumour patients
FDA Clears Expanded Indication of Acclarent AERA® Eustachian Tube Balloon Dilation System
Procedures may now be performed on patients as young as 18. New data on local anesthesia also recognized
Strong U.S. Sales Growth for joimax®: Now Company Launches MultiZYTE® Facet and SI Joint Treatment Set
joimax has also obtained full approval of its Endovapor® 2 system in China
FDA Clearance for MedShape DynaNail XL
New 260mm and 300mm offerings expand indications for NiTiNOL-based TTC Fusion device