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.
Approval/Clearance
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
Radar Breast Tumor Localization Gets FDA Clearance for Long Term Implant
Cianna Medical’s SCOUT system uses highly sophisticated radar technology for unprecedented precision
Abbott’s MitraClip First Transcatheter Mitral Valve Repair Device Approved in Japan
Japanese study data underpins approval
FDA Clears Stryker Cementless Mako Total Knee with Triathlon® Tritanium®
Stryker aims to strengthen its leadership position in robotic technology
FDA Clears K2M’s YUKON™ OCT Spinal System
Next-generation occipito-cervico-thoracic fusion system features an advanced polyaxial screw for degenerative & complex spinal pathologies
Pentax Medical Europe Unveils Unique Duodenoscope with Disposable Elevator Cap
CE mark for Pentax Medical’s DEC™ Duodenoscope delivers clinicians a unique solution for enhancing infection prevention and improving reprocessing efficiency, says company
FDA Approval and U.S. Launch of Medtronic’s New Chronic Intractable Pain Platform
Intellis includes the world’s smallest implantable spinal cord stimulator
U.S. 510(K) Clearance for Adherium’s Smartinhaler for AstraZeneca’s Symbicort Aerosol
Data show improved adherence by up to 59% in adults and 180% in children