Intact Vascular tells us a bit about its newly CE marked product and even refers us to its website for more information. Of which there is very little at this stage. How does it work, and what’s the plan for commercialisation? We’re looking forward to hearing because it sounds promising.
Approval/Clearance
CE Mark For Boston Scientific’s New Pacemakers
Boston Scientific has trumpeted the CE mark approval of its INGENIO™ and ADVANTIO™ pacemakers and INVIVE™ cardiac resynchronization therapy pacemakers.
Japanese Approval For Abbott’s XIENCE PRIME™ Drug Eluting Stent
Achieving device approval in Japan is a major undertaking, so Abbott must be delighted that its Xience Prime everolimus eluting stent has got the nod based on a robust body of clinical evidence.
Now FDA Expands Indication For Medtronic’s CRT-D Devices To Treat Mildly Symptomatic Heart Failure Patients
Medtronic declares itself pleased, but in reality must be absolutely delighted by the news that FDA has allowed it to expand the indications for its CRT-D resynchronisation/defibrillator devices to now include patients with mildly symptomatic heart failure.
CE Mark for Arrow® VPS® Catheter Tip Location And Guidance System
Teleflex has announced that following earlier US approval for its Arrow® VPS® (vascular positioning system), it has now gained CE mark approval and will be made immediately available in Europe.
Chronic Wound Spray CE Marked
If you’re going to the trouble to issue a press release, it really out to be a little more reader-friendly and maybe even contain some useful information. A wound spray to help chronic wounds heal sounds great, but most medical professionals might ask how (and how well) it works before they get too excited that it’s gained CE mark approval.
FDA Clears Expanded Indications For Anulex’s fiXate™ Tissue Band
Useful little device, fiXate™ from Anulex Technologies Inc., has now had its indications extended by FDA, allowing for its use in securing intrathecal pain pump catheters.
FDA Clears MATRx™ Device, Which Helps Predict Success For Oral Appliance Therapy In Sleep Apnea
Treatment decisions or sleep apnea sufferers need no longer be quite so hit and miss as FDA clears Somnomed’s MATRx device for predicting outcome of Oral Appliance Therapy
FDA Clears Soma’s AxoTrack™ Needle Visualisation System
Soma’s Axotrack looks like a compelling, ultrasound-guided solution to the challenge of accurate needle placement. The company’s two newly FDA cleared applications suggest the agency agrees.
Capsule Endoscopy Device Cleared For Crohn’s Diagnosis In Japan
Capsule Endoscopy marches forward with Given Imaging announcing the expansion of its indications in Japan to cover visualisation and diagnosis of Crohn’s disease.
Now LINX Reflux Management System Gains FDA Clearance
Torax’s LINX system of magnets acting to support the oesophageal sphincter gains FDA clearance.
Pretzelflex™ Laparoscopic Retractor Gains FDA Clearance
UK medical device company Surgical Innovations has gained FDA clearance for its Pretzelflex™ laparoscopic retractor.
CE Mark For Medtronic’s CD Horizon BalanC™Spinal System
Medtronic gains CE Mark approval for its CD HORIZON BalanC™ Spinal Fusion System, promising a new level of adaptablity to patient anatomy.
CE Mark for Spinal Motion’s Sub-5mm Kineflex®|C Cervical Total Disc Replacements
Cervical Disc Replacement specialist Spinal Motion has announced the CE marking of its sub 5mm Kineflex|C iterations.
Post-Operative Antiemetic Device Wins FDA 510(k) Clearance
FDA approval for non-invasive pressure device prevents Post-op nausea. Acupuncture without needles.
Cook’s Zilver® PTX™Peripheral Stent Gains Australian Approval
Vascular Surgeons in Australia now have access to a new technology, with the approval of Cook Medical’s Zilver PTX drug-eluting stent for treatment of peripheral artery disease.