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”
Products
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
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
$23 Million for CSA Medical to Advance Cryospray™ Therapies for Esophageal Disease and COPD
Financing will support Expansion of truFreeze® Spray Cryotherapy business for Esophageal Disease and launch of the Reo Radial Catheter in 2019 for Barrett’s Esophagus
NASS Sees Medtronic Launch of Infinity™ OCT Spinal System
System fully integrated with Medtronic’s imaging and navigation technology
U.S. May Soon Have First Meniscus Implant
With trials now fully enrolled Active Implants hopes its NUsurface® device might soon be available for U.S. patients