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
joimax has also obtained full approval of its Endovapor® 2 system in China
Endovascular stent graft study promises clinical results later this year
“It is a step towards developing a new treatment strategy that could have tremendous benefit for patients with refractory angina”
FDA allows study expansion and grants system “Breakthrough Device” status
Already available around the world, Pulmonx hopes to get FDA nod for U.S. patients
Biosense Webster, Inc. launches U.S. study to evaluate the safety and efficacy of the WaveCrest® Left Atrial Appendage Occlusion System