BD today announced it started enrollment in the first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB). The Prevision trial is a prospective, multi-center, single-arm, non-randomized study that will evaluate the safety of BD's DCB in the treatment of peripheral arterial disease (PAD) in the femoropopliteal arteries. The company … [Read more...] about BD initiates first-in-human trial of sirolimus drug-coated balloon
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The 24 best medical device innovations of 2022
The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products … [Read more...] about The 24 best medical device innovations of 2022
BD issues Class I recall of some intraosseous needle set kits and drivers
BD (NYSE:BDX) has issued a class I recall of its intraosseous needle set kits for its intraosseous infusion system. BD issued the recall of its intraosseous needle set kits, manual driver kits and powered drivers due to three separate issues. The needle set kits stylets could be difficult to separate from the needle or not separate at all. The … [Read more...] about BD issues Class I recall of some intraosseous needle set kits and drivers
BD acquires Venclose and its RF ablation technology
BD (NYSE:BDX) announced today that it acquired Venclose and its solutions for treating chronic venous insufficiency (CVI). CVI occurs as the result of malfunctioning valves and can lead to varicose veins. Venclose’s CVI treatment uses radio frequency (RF) ablation technology, with its catheters potentially reducing post-operative pain and … [Read more...] about BD acquires Venclose and its RF ablation technology
FDA clears expanded indications for BD’s Rotarex atherectomy system
BD this week announced that it has received FDA 510(k) clearance for expanded indications for its Rotarex atherectomy system. Franklin Lakes, N.J.-based BD designed the Rotarex as a rotational excision device that removes and aspirates varying lesion morphologies in the peripheral arteries. "The Rotarex atherectomy system is quick and … [Read more...] about FDA clears expanded indications for BD’s Rotarex atherectomy system
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to … [Read more...] about The 18 most innovative medical devices of 2021
BD announces ‘One-Stick Hospital Stay’ blood collection initiative
BD (NYSE:BDX) announced today that it plans to transform the patient experience through a “One-Stick Hospital Stay” blood collection solution. Franklin Lakes, N.J.–based BD said in a news release that its recent acquisition of Velano Vascular and its needle-free technology for high-quality blood draws from existing peripheral intravenous … [Read more...] about BD announces ‘One-Stick Hospital Stay’ blood collection initiative
BD home peritoneal catheter system wins expanded FDA clearance
BD today said it has received FDA 510(k) clearance for its PeritX peritoneal catheter system. Franklin Lakes, N.J.-based BD designed the catheter system to drain symptomatic, recurrent non-malignant ascites, which causes a build-up of fluid in the abdomen. The company's PleurX peritoneal catheter system was first introduced in 2005 to drain … [Read more...] about BD home peritoneal catheter system wins expanded FDA clearance
BD recalls certain IV cannulae in Europe, Asia
BD (NYSE: BDX) has issued a recall for certain lots of its Venflon Pro IV cannula due to the potential for leakage from the injection port. The company declared the latest recall "out of an abundance of caution" following a different voluntary recall for specified lots of BD Venflon Pro Safety Needle Protected IV cannula that shares the same … [Read more...] about BD recalls certain IV cannulae in Europe, Asia
BD enrolls first patients in arteriovenous endovascular fistula post-market trial
BD (NYSE: BDX) recently announced that it has begun enrollment for its post-market surveillance study of its WavelinQ arteriovenous endovascular fistula device. The Connect-AV trial is a prospective, single-arm, open-label study that will follow WavelinQ EndoAVF system patients for 24 months. Its dual primary effectiveness endpoints are the … [Read more...] about BD enrolls first patients in arteriovenous endovascular fistula post-market trial
