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.
Catheters
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
BioProtect closes $25M Series D equity financing round
BioProtect this week announced it closed a $25 million Series D equity financing round. Peregrine Ventures and an unnamed strategic investor completed the financing round that was led by Almeida Ventures and Vincent Tchenguiz, chairperson of Consensus Business Group. KB Investments of South Korea and Triventures also participated in the … [Read more...] about BioProtect closes $25M Series D equity financing round
Acutus Medical 3D imaging and mapping catheter wins FDA clearance
Acutus medical recently won FDA 510(k) clearance of its AcQMap 3D imaging and mapping catheter. The mapping catheter builds on its predecessor and improves handling and deliverability. It combines 48 ultrasound transducers responsible for creating anatomical geometry and 48 engineered electrodes that enable electrical activation patterns to … [Read more...] about Acutus Medical 3D imaging and mapping catheter wins FDA clearance
Prytime Medical launches aortic occlusion catheter
Prytime Medical recently launched its aortic occlusion catheter ER-REBOA Plus Catheter. The resuscitative endovascular balloon occlusion of the aorta (REBOA) catheter is designed for controlling massive non-compressible hemorrhage. “ER-REBOA Plus represents the evolution of REBOA based on experience and input from civilian trauma surgeons,” … [Read more...] about Prytime Medical launches aortic occlusion catheter
FDA clears Avinger image-guided CTO crossing system
Avinger this week announced it received FDA 510(k) clearance for its Ocelaris image-guided chronic total occlusion crossing system. The device will be marketed under the brand name TigerEye and will provide real-time imaging from inside the vessel during CTO-crossing procedures. “We are excited to receive U.S. pre-marketing clearance for … [Read more...] about FDA clears Avinger image-guided CTO crossing system
Johnson & Johnson’s Cerenovus launches new clot removal devices to treat stroke
Johnson & Johnson's Cerenovus recently announced it has launched its new stroke solutions platform that includes three devices for clot removal procedures. The three devices are designed to aid physicians in performing mechanical thrombectomy procedures. The devices include the Cerebase DA Guide Sheath, Cerenovus Large Bore Catheter and … [Read more...] about Johnson & Johnson’s Cerenovus launches new clot removal devices to treat stroke
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
InspireMD wins FDA approval for carotid stent system study
InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System. The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S. “This is a key milestone in the history of our company as it helps pave the way for … [Read more...] about InspireMD wins FDA approval for carotid stent system study
How fish physiology is enabling Boston Scientific to help atrial fibrillation patients
Company researchers developed cardiac ablation technology that mimics the navigation system of electric fish. Scientists have studied electric fish for decades to determine how and why they discharge electricity. Recently, a couple of biomedical engineers at Boston Scientific realized that the way these fish use their electrical impulses … [Read more...] about How fish physiology is enabling Boston Scientific to help atrial fibrillation patients
