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”
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”
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”
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®”
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”
BioCardia shows its newly cleared transseptal access system at Heart Rhythm Society congress in San Francisco
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.
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
E-XPE™ designed to provide wear resistance with reduced risk of oxidation: Now available in both knee inserts and hip liners
Eximo Medical Ltd. says it has received U.S. FDA 510(k) clearance for its B-Laser™ Atherectomy System for Peripheral Artery Disease (PAD)
New tissue expander with smooth surface aids insertion and removal in breast reconstruction surgery
With trials now fully enrolled Active Implants hopes its NUsurface® device might soon be available for U.S. patients
Experts welcome expansion of indication to include solid tumour patients
Persistent Paroxysmal Atrial Fibrillation in focus for heart rhythm specialist
A first patient has been treated in the EVAS2 IDE Confirmatory Clinical Study of the Nellix® EndoVascular Aneurysm Sealing system.
Procedures may now be performed on patients as young as 18. New data on local anesthesia also recognized