A string of positive news continues for Boston Scientific , which today announced FDA approval for its next-generation Watchman FLX. Last week, the company reported positive data for its Farapulse system, which led to a favorable reaction from analysts and the market. Just the week before, Boston Scientific received expanded FDA 510(k) clearance for its […]
Vascular
FDA clears VVT Medical varicose veins treatment device
VVT Medical announced in recent months that FDA has cleared its ScleroSafe platform, which delivers endovenous chemical ablation to treat superficial varicose veins. Kfar Saba, Israel–based VVT Medical says it specifically created ScleroSafe to provide efficient, non-thermal, non-tumescent treatment and management of varicosities in superficial veins. Its inverse-action dual syringe injects the ECA substance into […]
Rapid Medical wins Chinese approval for adjustable thrombectomy device
Rapid Medical announced today that it received Chinese approval for its Tigertriever revascularization device for blood clot removal. Yokneam, Israel-based Rapid Medical designed Tigertriever to remove thrombus from delicate brain blood vessels during an ischemic stroke. With National Medical Product Administration (NMPA) approval, it becomes the first device to offer patient-specific solutions for this treatment. […]
LivaNova wins FDA clearance, CE mark for Essenz in-line blood monitor
LivaNova announced today that it received FDA 510(k) clearance and CE mark for its Essenz in-line blood monitor. Essenz ILBM provides accurate and continuous measurement of essential blood parameters throughout cardiopulmonary bypass (CPB) procedures, according to LivaNova. It integrates into the next-generation Essenz perfusion system. Essenz enables perfusionists to access and manage reliable blood parameters […]
Haemonetics brings vascular closure device to Europe
Haemonetics (NYSE:HAE) today announced the first patients treated with its Vascade MVP venous vascular closure system in Germany. Boston-based Haemonetics said this marks the first use of the Vascade portfolio — widely used in the U.S. — in a European country. The company designed Vascade for small-bore femoral arterial and venous closure. Its general uses […]
GE HealthCare unveils wireless, handheld ultrasound device
GE HealthCare announced today that it launched its Vscan Air SL handheld ultrasound imaging system. The company debuted the first Vscan color pocket-sized ultrasound in 2010. Today, more than 50,000 Vscan platform devices are out in the field. The FDA cleared the initial GE HealthCare Vscan Air CL system in late 2020. The company then […]
FDA fast-tracks aneurysm stabilization system from Nectero Medical
Nectero Medical announced today that the FDA granted fast track designation to its endovascular aneurysm stabilization treatment (EAST) system. Tempe, Arizona–based Nectero designed its EAST system to treat patients with abdominal aortic aneurysm (AAA). These AAAs have a maximum diameter of 3.5 cm to 5 cm. The company plans to initiate a randomized, controlled Phase […]
MagAssist wins FDA breakthrough nod for ventricular assist device
MagAssist announced today that it received breakthrough device designation from the FDA for its NyokAssist ventricular assist device. The interventional VAD provides mechanical circulatory support for high-risk percutaneous interventions. It features a 9 Fr insertion size with a foldable catheter pump to facilitate insertion and removal. This reduces the vascular access and closure processes. Its […]
Teleflex extends Arrow ErgoPack system with hemodialysis, large bore catheters
Teleflex announced today that it released its Arrow ErgoPack complete kits with hemodialysis and larbe bore catheters in the U.S. Wayne, Pennsylvania-based Teleflex launched this update to streamline insertion workflow for clinicians. The company also says it provides more options to suit their particular needs. Get the full story at our sister site, Medical Tubing […]
Getinge subsidiary Datascope has another serious intra-aortic balloon pump recall
The FDA issued a notice labeling another recall of Getinge subsidiary Datascope’s Cardiosave pump as Class I, the most serious kind. This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs). Both devices were subject to two separate Class I recalls in March. The company also initiated a Class I […]
Shockwave Medical increases offering price to $650M
One day after proposing a private offering worth proceeds of $500 million, Shockwave Medical announced a price increase for that offering. The Santa Clara, California-based calcified cardiovascular disease treatment developer announced its private offering yesterday, Aug. 10. That announcement covered convertible senior notes due in 2028. It featured an additional option to purchase, within 13 […]