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
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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
4 catheter-based devices to watch for in 2021
Medical device companies are working to gain regulatory approvals and launch new catheter-based devices as the world slowly returns to normal after reeling from the COVID-19 pandemic. As of April 19, the FDA had approved 11 medical devices this year — two of them catheter-based. In comparison, the regulatory agency approved 19 devices by April … [Read more...] about 4 catheter-based devices to watch for in 2021
BD lands FDA clearance for hemodialysis catheter
BD (NYSE:BDX) this week said it has received FDA 510(k) clearance for its Pristine long-term hemodialysis catheter. The catheter has a side-hole free symmetric Y-tip distal lumen design that is designed to minimize thrombus adhesion and help facilitate blood clot aspiration prior to hemodialysis treatment. Its symmetric tip is designed to help … [Read more...] about BD lands FDA clearance for hemodialysis catheter
FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
An FDA advisory panel voted against a favorable recommendation for BD's Lutonix catheter-based, drug-coated balloon for use below the knee. The FDA's Circulatory System Devices Advisory Panel yesterday voted 15-to-2 in favor of the issue of safety when Lutonix is used as intended and voted 15-to-2 against the issue of a reasonable assurance of … [Read more...] about FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
BD launches Halo One thin-walled guiding sheath
Becton Dickinson (NYSE:BDX) has launched its Halo One Thin-Walled Guiding Sheath for peripheral arterial and venous procedures. The device features a 1 Fr wall thickness sheath made from braided single-lumen tubing that is fitted with a female lure hub at the proximal end and a formed atraumatic distal tip. The thin wall reduces the size of the … [Read more...] about BD launches Halo One thin-walled guiding sheath
