Cook Medical today announced it signed a U.S. distribution agreement with Bentley for the BeBack catheter. Under the agreement, Cook Medical will assume commercial responsibilities for this Bentley product. “We are excited to welcome Bentley’s BeBack catheter to our peripheral intervention portfolio,” Alec Cerchiari, director of product … [Read more...] about Cook Medical signs distribution agreement with Bentley for BeBack catheter
ProVerum completes enrollment in ProVIDE clinical study for ProVee BPH treatment device
ProVerum this week announced it completed enrollment in its ProVIDE pivotal clinical trial to evaluate the safety and effectiveness of the ProVee system. The ProVIDE clinical trial is a prospective, multicenter, double-blind controlled study that evaluates the safety, performance, and effectiveness of the ProVee system in patients with lower … [Read more...] about ProVerum completes enrollment in ProVIDE clinical study for ProVee BPH treatment device
Cook Medical’s shorter Liver Access and Biopsy Set wins expanded indication
Cook Medical this week announced its shorter Liver Access and Biopsy Set (LABS) received pediatric indication. LABS was originally intended for use in adults, but was recently FDA cleared for use in adolescents, children and infants. The Bloomington, Indiana-based company designed the device for use in obtaining liver histology samples via … [Read more...] about Cook Medical’s shorter Liver Access and Biopsy Set wins expanded indication
PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device
PulseCath this week announced it received CE mark approval for its iVAC 2L percutaneous mechanical circulatory support device. The iVAC 2L device helps facilitate high-risk percutaneous coronary interventions. PulseCath designed it to pump blood from the left ventricle to the aorta in synchronization with the natural rhythm of the patient's … [Read more...] about PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device
Pentax Medical’s i20c video endoscopes wins CE mark
Pentax Medical this week announced it received CE mark approvals for new models of its i20c video endopscope series. The approval covers the Pentax Medical Video Colonoscope EC34-i20c, Pentax Medical Upper GI Scope EG27-i20c and the R/L Knob Adaptor OE-B17. Pentax Medical's i20c Video Endoscope Series, when used with the Inspira Video … [Read more...] about Pentax Medical’s i20c video endoscopes wins CE mark
FDA clears FujiFilm’s Scale Eye endoscopic imaging tech
FujiFilm today announced it received FDA 510(k) clearance for its Scale Eye endoscopic imaging technology. Scale Eye is part of the company's expanding Eluxeo endoscopic imaging system. It has a laser-equipped colonoscope and endoscopy support software that displays linear or circular vital measurements or scales on an endoscopy monitor. The … [Read more...] about FDA clears FujiFilm’s Scale Eye endoscopic imaging tech
Boston Scientific warns on fragment embolization in some PolarSheath devices
Boston Scientific has issued an urgent field safety notice for some of its PolarSheath steerable sheaths due to the risk of embolization. The company is removing specific batches of PolarSheath steerable sheaths due to a tooling error in manufacturing, which may have caused delimitation of the inner lumen of the sheath shaft in a subset of … [Read more...] about Boston Scientific warns on fragment embolization in some PolarSheath devices
Vena Medical achieves first-in-patient for its MicroAngioscope
Vena Medical this week announced that physicians at The Ottawa Hospital (TOH) were the first to use its stroke technology, the MicroAngioscope. Dr. Robert Fahed, an interventional neuroradiologist at TOH, used the MicroAngioscope to treat a patient who had repeated strokes. According to TOH, the device's advanced and high-resolution imaging … [Read more...] about Vena Medical achieves first-in-patient for its MicroAngioscope
FDA clears AngioDynamics’ Auryon XL catheter
AngioDynamics announced today that it received FDA 510(k) clearance for its Auryon XL catheter for use with the Auryon atherectomy system in treating peripheral arterial disease (PAD). The Auryon XP catheter is a 225 cm radial access catheter available in 0.9 mm and 1.5 mm diameters to expand treatment access points in atherectomy procedures in … [Read more...] about FDA clears AngioDynamics’ Auryon XL catheter
The worst catheter-based device recalls of 2023
The U.S. saw seven severe catheter-based device recalls in 2023, according to the FDA's medical device recall database. The agency in 2023 tagged 61 medical device recalls as Class I — the most serious level. For comparison, the FDA recalled 60 devices in 2022, of which four were related to catheter-based devices. Last year, the most serious … [Read more...] about The worst catheter-based device recalls of 2023
