Products

Imaging device Specialist NinePoint Medical, Inc., has completed a $34 million Series B financing which it says will support the ongoing commercial launch of the NvisionVLE Imaging System in the U.S., as well as development of the company’s expanded product offering.

Proton Beam Therapy specialist company ProTom International, Inc. has announced that it has received U.S. FDA 510(k) clearance for its Radiance 330 Proton Therapy System.

Medical robotics company (the clue’s in the name) Medrobotics Corp., has gained the CE mark for its Flex® System and will initiate a limited commercial launch of the product in select European markets.

Volcano Corporation a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced FDA clearance of its proprietary instant wave-Free Ratio™ or iFR® Modality.

The last time we covered NeuroMetrix, Inc., it was the news that its SENSUS Pain Management System had become the first … continue reading “Improved NeuroMetrix SENSUS Device Launched”

Implantable lens manufacturer STAAR Surgical Company tells us that its Visian Toric Implantable Lens or TICL received favorable votes to three questions presented to the U.S. FDA’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee.

German ultrasound expert, eZono AG has received FDA 510(k) clearance for its eZono 4000 dedicated procedural guidance system with eZGuide technology, providing “any plane” freehand navigation.

Newly FDA cleared Restated Indications for Use modify the weight range for Teleflex’s EZ-IO® 25 mm Needle Set for patients 3 kg or over.

Thoratec has issued updated information regarding the problems highlighted in its device correction letter of two weeks ago. It’s reinforcing the guidance that patients should visit their doctor for retraining on how to use the Heartmate II device in the light of new evidence that the process of changing from older controllers presents the highest risk of problems.

BioCardia®, Inc. has gained CE Mark approval for its Morph AccessPro™ Steerable Introducer, designed for easier navigation through the vasculature during delivery of biotherapeutics and medical devices.

Boston Scientific Corporation has announced CE Mark approval and European market launch of the INGEVITY™ family of magnetic resonance imaging (MRI) compatible pacing leads.

Boston Scientific Corporation has received CE Mark approval for the REBEL™ Platinum Chromium Coronary Stent System, the company’s latest generation … continue reading “CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent”

Scottish vascular graft company Vascutek has announced the return to market of its Anaconda™ Bifurcate Body Stent Graft System. The system has been out of circulation since October 2013.

Integra LifeSciences Holdings Corporation has announced the first implantation of its Integra® Laminoplasty System, in the United States, a product it hopes will help it garner a chunk of the rapidly growing laminoplasty market.

Smith & Nephew has used the AAOS annual meeting at which to announce the launch of the JOURNEY™ II Cruciate Retaining knee replacement which it says will address about half of all knee replacement cases.

Smith & Nephew says its newly launched DYONICS PLAN system allows surgeons to visualize, assess and generate a comprehensive surgical report for each patient’s unique Femoroacetabular impingement surgery before that patient ever enters the operating room.