Fujifilm recently announced it received FDA 510(k) clearance for its EG-740UT1 linear endoscopic ultrasound scope that is compatible with its Arietta 8502 ultrasound processor. The company designed EG-740UT for diagnostic and therapeutic endoscopic ultrasound procedures in the upper digestive tract, including the esophagus, stomach and duodenum. … [Read more...] about Fujifilm wins FDA clearance for endoscopic ultrasound scope with Arietta 850 processor
Acutus Medical submits AcQBlate force-sensing ablation catheter for FDA premarket approval
Acutus Medical today announced it submitted pivotal clinical data of its AcQBlate force-sensing ablation catheter to the FDA for premarket approval. The Carlsbad, California-based company submitted data from the AcQForce Flutter trial, a prospective, multicenter, non-randomized study approved under an FDA investigational device exemption … [Read more...] about Acutus Medical submits AcQBlate force-sensing ablation catheter for FDA premarket approval
Biosense Webster launches HelioStar in Europe
Biosense Webster today launched its HelioStar balloon ablation catheter in Europe. Johnson & Johnson's subsidiary Biosense Webster launched the radiofrequency balloon ablation catheter for catheter-based cardiac electrophysiological mapping of the atria when used with a multi-channel RF generator. According to the company, more than 11 … [Read more...] about Biosense Webster launches HelioStar in Europe
Ancora Heart appoints David Tucker as CFO
Ancora Heart today announced it appointed David Tucker as chief financial officer. Tucker will be responsible for the Santa Clara, California-based company's financial strategies and operations as it enrolls patients in the Corcinch-HF pivotal clinical trial of its AccuCinch ventricular restoration system. “David’s experience includes … [Read more...] about Ancora Heart appoints David Tucker as CFO
How this inside-out vascular access system simplifies catheter placement
Bluegrass Vascular Technologies is making catheter placement procedures for dialysis and chemotherapy easier and safer using inside-out technology, explains CEO and President Gabi Niederauer. Bluegrass Vascular Technologies has figured out a way to make a catheter sheath go inside the body and back out for easy catheter placement in standard … [Read more...] about How this inside-out vascular access system simplifies catheter placement
FDA labels Medtronic recall of some endotracheal tubes as Class I
The FDA this week said the Medtronic recall of some NIM Contact Reinforced EMG endotracheal tubes is Class I, the most serious kind. Medtronic is recalling its NIM Contact Reinforced EMG endotracheal tubes and NIM Standard Reinforced EMG endotracheal tubes due to reports of obstruction of the endotracheal tube while in use in patients. Tube … [Read more...] about FDA labels Medtronic recall of some endotracheal tubes as Class I
Ra Medical enters agreement to merge with Catheter Precision
Ra Medical Systems today announced it entered a merger agreement with Catheter Precision. Under terms of the agreement, Catheter Precision will become a wholly-owned subsidiary of Ra Medical in a stock-for-stock reverse merger transaction. Upon completion, the combined publicly traded company will focus on the cardiac electrophysiology … [Read more...] about Ra Medical enters agreement to merge with Catheter Precision
Haemonetics wins CE mark for Vascade vascular closure device
Haemonetics today announced it received CE mark approval for its Vascade vascular closure and Vascade MVP venous vascular closure systems. The CE mark approval will allow the Boston-based company to enter specific markets in the European Union, as well as other regions that recognize the regulatory marking. Haemonetics designed the Vascade … [Read more...] about Haemonetics wins CE mark for Vascade vascular closure device
LeMaitre Vascular warns on some Syntel Silicone over-the-wire embolectomy catheters
LeMaitre Vascular (NSDQ:LMAT) recently issued an urgent field safety notice for some of its Syntel Silicone over-the-wire embolectomy catheters. The Burlington, Massachusetts-based company issued the warning due to the French size next to the outside diameter symbol on the label not reflecting the 5 Fr catheter extrusion used on all models of … [Read more...] about LeMaitre Vascular warns on some Syntel Silicone over-the-wire embolectomy catheters
Gore voluntarily recalls some balloon catheters
W.L. Gore and Associates recently announced the voluntary product recall of its Molding and Occlusion Balloon (MOB) Catheters. The Newark, Delaware-based manufacturing company issued the warning due to complaints of leakage from the guidewire lumen and the y-hub during the preparation or use of the MOB catheters. The issue could result in … [Read more...] about Gore voluntarily recalls some balloon catheters