BD announced today that it launched new, FDA-cleared needle-free blood draw technology. The launch of the technology helps to further enable the company’s “One-Stick Hospital Stay” initiative. BD announced this initiative more than two years ago in an effort to transform the patient experience. With FDA 510(k) clearance, BD can now offer its new PIVO […]
Blood Management
Shifamed’s Akura Medical raises $35M for thrombectomy system
Akura Medical, a Shifamed portfolio company, today announced the closing of a $35 million Series B financing round. Los Gatos, California-based Akura develops a differentiated approach to address the challenges of venous thromboembolism (VTE). The company earmarked the funds for supporting its FDA 510(k) clearance submission for the Akura mechanical thrombectomy platform. Other uses include […]
SeaStar wins FDA breakthrough nod for selective cytopheretic device
SeaStar Medical (Nasdaq:ICU) announced today that the FDA granted breakthrough device designation for its selective cytopheretic device (SCD). Denver-based SeaStar designed the SCD for use in patients in the intensive care unit (ICU) with acute or chronic systolic heart failure. These patients have worsening renal function due to cardiorenal syndrome or right ventricular dysfunction. They’re awaiting […]
PercAssist treats first patient in heart failure support trial
PercAssist announced today that it successfully completed the first patient treatment in its EUREKA first-in-human clinical study. The study evaluates PercAssist’s minimally invasive extravascular platform that provides hemodynamic support for chronic heart failure patients. Principal investigator Dr. Petr Neuzil completed the first case at the Na Homolce Hospital in Prague, Czech Republic. Also involved were […]
FDA approves LimFlow chronic limb-threatening ischemia treatment
LimFlow announced today that the FDA approved its LimFlow System for treating chronic limb-threatening ischemia (CLTI). Approval enables the treatment to help those with CLTI with no other suitable endovascular or surgical treatment options available. These patients can face major amputation as a result of their condition. France-based LimFlow designed its TADV (transcatheter arterialization of […]
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 […]
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 […]
FDA clears Abbott Alinity h-series hematology system
Abbott announced today that the FDA cleared its advanced Alinity h-series hematology system. FDA clearance enables laboratories to run complete blood counts (CBCs) as part of Abbott’s Alinity family of diagnostic products. CBCs, among the most ordered tests in healthcare, help to screen for a variety of disorders. That includes infections, anemia, diseases of the […]
Teleflex wins expanded FDA indication for QuikClot Control+ hemostatic device
Teleflex announced today that the FDA expanded the indication for its QuikClot Control+ device. The expanded indication for the hemostatic device includes mild and moderate bleeding in cardiac surgical procedures. It also includes bone surface bleeding following a sternotomy. Indication expansion allows clinicians to use QuikClot Control+ to control all bleeding in cardiac surgical procedures. […]