MIVI Neuroscience won FDA approval to start a human clinical study of its MIVI Q aspiration catheter in the U.S. The EVaQ Study V catheter's ability to remove thrombus and blockages that can cause large vessel occlusions in arteries of the brain. This study is a single-arm study with planned patient enrollment in up to 12 clinical centers in … [Read more...] about MIVI Neurosciences wins FDA approval for aspiration catheter clinical study
Technologies & Devices
BD launches Halo One thin-walled guiding sheath
Becton Dickinson (NYSE:BDX) has launched its Halo One Thin-Walled Guiding Sheath for peripheral arterial and venous procedures. The device features a 1 Fr wall thickness sheath made from braided single-lumen tubing that is fitted with a female lure hub at the proximal end and a formed atraumatic distal tip. The thin wall reduces the size of the … [Read more...] about BD launches Halo One thin-walled guiding sheath
Boston Scientific launches DirectSense technology
Boston Scientific (NYSE:BSX) announced today that it launched its DirectSense for monitoring the effect of radiofrequency (RF) energy during cardiac ablation procedures. Marlborough, Mass.-based Boston Scientific’s DirectSense is available on the Rhythmia HDx mapping system that won FDA approval in April. Rhythmia HDx monitors changes in local … [Read more...] about Boston Scientific launches DirectSense technology
What is an echogenic catheter?
Health providers use echogenic catheters to improve visibility in a number of ultrasound-guided catheterizations. The catheters have been used in many applications. For example, echogenic catheter-over-needle systems can be used for continuous nerve block. Echogenic catheters have also been used for ultrasound-guided embryo transfer in in vitro … [Read more...] about What is an echogenic catheter?
Acutus Medical, Biotronik ink deal
Acutus Medical and Biotronik have announced that they will collaborate on electrophysiology, mapping, ablation and accessory products across certain markets. Under the agreement, Acutus expects to market a range of Biotronik EP ablation catheters and diagnostic/accessory products under a private label to most international markets. The companies … [Read more...] about Acutus Medical, Biotronik ink deal
How silicone tubing is used in designing medical devices
When it comes to silicone tubing, medical device designer need to consider a wide variety of mechanical properties. Dan Sanchez, Product Manager, Trelleborg Healthcare & Medical The global medical tubing segment continues to rise at a significant rate and is expected to reach $9.4 billion by 2022, according to MarketsandMarkets Research. … [Read more...] about How silicone tubing is used in designing medical devices
Ra Medical threatened with stock exchange delisting
Ra Medical Systems (NYSE:RMED) announced today that it received notice that is is no longer in compliance with the New York Stock Exchange’s listing standards. The Carlsbad, Calif.-based company learned that it is not complying with the NYSE continued listing standard that requires companies to maintain an average closing share price of at least … [Read more...] about Ra Medical threatened with stock exchange delisting
What is a microcatheter?
A microcatheter is a small diameter catheter that is used in minimally invasive procedures for delivering devices. Its small build makes it ideal for navigating complex vasculature within the human body. Microcatheters are small 0.70-1.30mm diameter catheters that are used for guidewire support, exchanges, to access distal anatomy, cross … [Read more...] about What is a microcatheter?
GI Supply launches device to reduce necrotic tissue, pancreatic blood fluids
GI Supply recently launched its Piranha Aspiration Catheter for necrotic tissue suction. The device is designed for better management of necrotizing pancreatitis for endoscopic transmural necrosectomy by improving the suction of necrotic tissue and pancreatic blood fluids. Piranha LC suctions necrotic tissue and pancreatic blood fluids in the … [Read more...] about GI Supply launches device to reduce necrotic tissue, pancreatic blood fluids
FDA labels Applied Medical catheter recall as Class I
The FDA announced yesterday that the Applied Medical recall of multiple kinds of its catheters is designated as Class I, the most serious type of recall. The Python embolectomy catheters, Bard embolectomy catheters and the OTW Latis cleaning catheters were the types recalled by Applied Medical. A total of 19,400 devices were recalled in the … [Read more...] about FDA labels Applied Medical catheter recall as Class I
