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”
Products
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”
Limited Release of BioCardia AVANCE™ Steerable CV Catheter Introducer
Following its recent FDA clearance, BioCardia, Inc. has confirmed the U.S. commercial availability of the AVANCE™ Bi-Directional Steerable Introducer Sheath for introducing … continue reading “Limited Release of BioCardia AVANCE™ Steerable CV Catheter Introducer”
Medtronic Submits InterStim™ Micro Neurostimulator and SureScan™ MRI Leads to FDA
Medtronic plc tells us it has filed a pre-market approval (PMA) supplement with the U.S. FDA for approval of its … continue reading “Medtronic Submits InterStim™ Micro Neurostimulator and SureScan™ MRI Leads to FDA”
Ethicon’s New Stapler Targets Anastomotic Leak Reduction
J & J company, Ethicon has announced the launch of the ECHELON CIRCULAR™ Powered Stapler which preclinical studies say reduce … continue reading “Ethicon’s New Stapler Targets Anastomotic Leak Reduction”
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”
Boston Scientific’s New TACTRA™ Penile Prosthesis
This new implant provides patients with a durable, natural-feeling implant for the treatment of erectile dysfunction. Background Erectile dysfunction (ED) … continue reading “Boston Scientific’s New TACTRA™ Penile Prosthesis”
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
Non-Invasive Headache Therapy System Selected for NHS England Innovation and Technology Payment Program
electroCore’s gammaCore™ chosen by NHS England to be funded by the Innovation and Technology Payment Program to support adoption in the U.K.
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.
New WatchPAT Advances Home Sleep Apnea Testing
Latest WatchPAT innovation improves patient comfort and simplifies physician workflow
Single Use Surgical’s Extended Suction Range at Arab Health 2019
Single Use Surgical will be at Arab Health 2019 to source new distributor partners from the region
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