Contact-force sensing cardiac ablation for arrhythmia treatment has taken a step forward with the announcement by Endosense that its newest iteration device has been used in a US patient for the first time. The device has been on general release in Europe since last June.
Regulatory
FDA Nod For Ethicon Endo’s ENSEAL® G2 Articulating Tissue Sealer
Ethicon Endo-Surgery says its ENSEAL® advanced bipolar devices are strong on sealing, yet gentle on tissue. And now with a new Articulating iteration these benefits can be exploited in the most difficult-to-access anatomies.
Medtronic’s Newly CE Marked Evera® ICD Claims Enhanced Longevity, Shock Reduction And Patient Comfort
We’re always on the look-out for technologies that nudge the state of play forward. Medtronic’s next-generation Evera® ICDs offer patients proven treatment performance, increased longevity, improved comfort and are now CE marked.
Digirad’s Ergo™ Imaging System Sees Indications Extended
Digirad’s highly ergonomic ergo Imaging System has seen its utility extended to more applications with a new FDA 510(k) clearance. ergo can now be used in nuclear medicine, surgery and women’s health.
Eucomed’s Considered Response Says MDD Proposals Fall Short On Notified Body Control
Eu medtech Industry body Eucomed believes improvements to the European Commission’s proposal are necessary to guarantee patient safety, ensure patient access and keep innovation in Europe.
Worldwide Recall For T-piece Circuit used on GE Healthcare’s Giraffe and Panda
The FDA has seen fit to publicise GE Healthcare’s Class I recall of its T-piece circuit used with its Giraffe and Panda resuscitation units. Customers have been advised not to use the identified parts, although no patient has yet suffered injury as a consequence of device performance.
CE Mark For Direct Flow’s Novel Polymer-Ring-Design Transcatheter Aortic Heart Valve System
California’s Direct Flow Medical®, Inc., has gained CE Mark approval for its distinctive transcatheter aortic heart valve with a metal-free frame and low-profile transfemoral delivery system. The system uses a twin-donut effect fillable ring to optimise positioning.
CE Mark For Next Generation Ultrasound Renal Denervation System
VHS/Betamax/Bluetooth/DVD/Ultrasound/RF? It seems like we’re approaching a technology stand-off in the growing world of renal denervation. Ultrasound advocates claim advantages in reaching the nerves RF can only reach by heating things up a bit too much.
FDA Clears Novel Minimal Access Distal Radius Fracture System
We’re loving the number of really clever devices coming before us at the moment. This really smart device for performing distal radius fracture fixation in a minimally invasive manner is a case in point.
FDA Clears TraceIT Hydrogel Tissue Marker, Visible On CT, MR and Ultrasound.
Augmenix, Inc. has received FDA 510(k) clearance to market its TraceIT Tissue Marker, an absorbable tissue marker visible under CT, MR, cone beam and ultrasound imaging modalities.
CE Mark For Biosensors BioFreedom™ Stent
So, a drug eluting stent which doesn’t rely on a polymer coating to carry the drug. Clever. And now CE marked in the form of BioFreedom from Biosensors International.
GORE® DrySeal Sheath Aids Endovascular Device Insertion And Minimises Blood Loss
Gore launches a new sheath design in Europe, which it says delivers easier insertion and removal of endovascular devices for AAA and TAA.
FDA Clears Varian’s Edge™ Radiosurgery Suite For Non-Invasive Surgical Procedures
Varian Medical Systems has received FDA 510(k) clearance for the company’s Edge™ radiosurgery suite, a new dedicated system for performing advanced radiosurgery using innovative real-time tumor tracking and motion management technologies.
Medtronic’s Complete ‘SE’ Vascular Stent Sees CE Indication Expanded To Lower-Extremity
Medtronic, Inc. has announced the CE mark and international launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities, specifically the superficial femoral arteries and proximal popliteal arteries.
FDA 510(k) Clearance for Varian’s Vitesse™ Brachytherapy Treatment Planning Software
Varian Medical Systems has gained FDA 510(k) clearance for the latest version of its Vitesse™ real time planning for high dose rate (HDR) brachytherapy which is used to plan and perform HDR, ultrasound-guided brachytherapy treatments for prostate cancer.
SPR™ Therapeutics Receives CE Mark For Smartpatch® PNS System
Neurodevice firm SPR Therapeutics has received the CE mark for its Smartpatch system, a peripheral nerve stimulation (PNS) therapy for the minimally-invasive treatment of pain. The first indication to receive CE certification is chronic shoulder pain.