410 Medical Innovations said in a regulatory filing today that it raised a funding round worth $2.2 million. Durham, N.C.-based 410 Medical developed the LifeFlow rapid infuser for critically ill patients needing urgent fluid delivery. The device is designed to allow front-line healthcare providers to deliver 1 liter of crystalloid fluid through a 20-gauge IV catheter in 5 minutes. Some […]
Blood Management
Neuravi wins CE Mark for EmboTrap II stent retriever
Neuravi said today it won CE Mark approval in the European Union for its EmboTrap II stent retriever and revascularization device. The device is a next-gen version of the company’s EmboTrap, and is designed to treat a broader range of clots with sizes that are deliverable through a 0.021″ microcatheter. “The EmboTrap platform has been a […]
FDA approves Concentric Medical’s Trevo clot retrievers
UPDATED Sept. 7, 2016, with comment from Stryker The FDA said today that it granted expanded approval to 2 of Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities. The indications expand previous clearances for the devices, […]
Braun lands FDA nod for Xevonta dialyzer
B. Braun Medical said today it won FDA 510(k) clearance for its xevonta dialyzer and that it is launching the next-generation filter in the U.S. Get the full story at our sister site, Medical Design & Outsourcing.
Bio2 Medical wins FDA clearance for embolism-snaring Angel catheter
BiO2 Medical said today it won FDA 510(k) clearance for its Angel Catheter designed for pulmonary embolism protection by trapping clinically significant pulmonary emboli. The Golden, Colo.-based company said the clearance includes a 1st ever prophylactic indication to protect critically ill patients at high risk for pulmonary embolism and are contraindicated for anticoagulation. “We are excited […]
Arch Therapeutics touts 1st-in-human for novel blood control device
Arch Therapeutics (OTC:ARTH) yesterday announced the completion of the 1st-in-human study of its novel AC5 topical hemostatic device, touting that study primary objectives were met with no serious adverse events and safety outcomes similar between the AC5 and control groups. The study aimed to evaluate the safety and performance of the AC5 in patients undergoing excision of […]
TAVR: Study shows benefit of Claret Medical’s Sentinel cerebral protection device
A study released this week reported that the use of Claret Medical’s cerebral protection device during transcatheter aortic valve implantation procedures in patients with severe aortic stenosis can reduce the number and volume of brain lesions. The study, which received funding from Claret and Medtronic (NYSE:MDT), was published in the August 9 issue of the The […]
Pursuit Vascular raises $2.1m
Pursuit Vascular has raised $2.1 million in a new round of debt financing, according to an SEC filing posted today. Maple Grove, Minn.-based Pursuit Vascular produces the ClearGueard HD end caps for hemodialysis catheters, designed to kill bacteria inside long-term hemodialysis catheters. The caps are designed with a chlorhexidine-coated rod that extends into the catheter […]
Aethlon claims 50% blood serum clearance of Zika virus in 5 hours
Aethlon Medical (OTC:AEMD) said today that data from in vitro Zika virus studies of its Hemopurifier blood filter indicated a 50% clearance of the virus from human blood serum in 5 hours. The San Diego, Calif.-based company said the Zika studies, which were conducted with small-scale versions of the Hemopurifier, also reported a 95% clearance rate of […]
Haemonetics sees shares rise on Q1 release
Haemonetics (NYSE:HAE) has seen shares rise despite releasing 1st quarter earnings that saw losses grow and earnings per share shrink compared to last year. The Braintree, Mass.-based company reported losses of $10.3 million, or 20¢ per share, on sales of $210 million for the 3 months ended July 2. The company saw bottom-line losses grow from […]
Baxter touts study indicating cost savings with Revaclear dialyzer
Baxter (NYSE:BAX) today released results from a study of its Revaclear high-flux dialyzer, touting lower use of erythropoiesis-stimulating agent with the filter. Use of the Revaclear dialyzer was associated with 100 to 600 fewer units of ESA used per hemodialysis session when compared against Optiflux 160 or Optiflux 180 dialyzers, Deerfield, Ill.-based Baxter said. ”Maintaining hemoglobin […]