Royal Philips (NYSE:PHG) announced today that one-year results of its Define PCI study that reported improved outcomes and less recurrent angina. The Define PCI study assessed the level of residual ischemia found in patients following a percutaneous coronary intervention (PCI) using a blinded instant wave-free ratio (iFR) pullback measurement, … [Read more...] about Philips touts post-stent imaging study results
NanoVibronix device gains FDA nod for import to U.S.
NanoVibronix (NSDQ:NAOV) announced that it received FDA enforcement discretion for the U.S. distribution of the UroShield device. According to a news release, the FDA exercised its enforcement discretion, giving Elmsford, N.Y.-based NanoVibronix’s UroShield an intended use code (IUC), clearing the way for the import of the system to the U.S. … [Read more...] about NanoVibronix device gains FDA nod for import to U.S.
Boston Scientific warns on Hurricane RX biliary balloon dilatation catheter
Boston Scientific (NYSE:BSX) said it is recalling specific lots/batches of its Hurricane RX biliary balloon dilation catheters. Marlborough, Mass.-based Boston Scientific, which issued a warning letter from its international location in France, said the removal comes in response to an increase in complaints of the RX tunnel component (black … [Read more...] about Boston Scientific warns on Hurricane RX biliary balloon dilatation catheter
Saint-Gobain Life Sciences buys MS Techniques and Transluminal
Saint-Gobain Life Sciences announced today that it is acquiring MS Techniques and Transluminal to expand its medical components capabilities. Pompey, France-based MS Techniques, a 137-person company, offers experience in high-precision thermoplastic extrusion and design expertise for minimally invasive catheter solutions centered around the … [Read more...] about Saint-Gobain Life Sciences buys MS Techniques and Transluminal
Medtronic touts cryoablation therapy study results
Medtronic (NYSE:MDT) touted results demonstrating the superiority of two of its cryoablation therapy technologies. Fridley, Minn.-based Medtronic said in a news release that trials showed the superiority of the Arctic Front advance cardiac cryoballoon and the Freezor max cardiac cryoablation catheter for the first-line treatment (before drug … [Read more...] about Medtronic touts cryoablation therapy study results
AngioDynamics lands 510(k) for ‘smart’ implantable port
AngioDynamics (NSDQ:ANGO) announced that it received FDA 510(k) clearance and CE Mark approval for its SmartPort+ implantable port product. SmartPort+ is an implantable, subcutaneous port for those who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids, according to a news … [Read more...] about AngioDynamics lands 510(k) for ‘smart’ implantable port
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
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
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
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
