Baxter (NYSE:BAX) said today it launched 2 new clinical trials exploring expanded HDx hemodialysis therapy using its Theranova dialyzer. The Deerfield, Ill.-based company’s HDx therapy uses a Theranova dialyzer designed to extend the range of molecules that it filters from the blood, claiming it “more closely mimics the natural kidney.” The therapy works on standard equipment […]
Blood Management
Velico Medical raises another $19m for Frontline ODP spray-dried plasma
Velico Medical said today that it raised another $19 million for the Frontline ODP spray-dried plasma product it’s developing. Beverly, Mass.-base Velico said the $18.9 million contribution comes from the U.S. Health & Human Services Dept.’s Biomedical Advanced Research & Development Authority. It’s the third option under a contract with Velico that runs through November 2019, […]
Aethlon Medical wins FDA EAP designation for Hemopurifier
Aethlon Medical (NSDQ:AEMD) said today it received an Expedited Access Pathway designation for its Aethlon Hemopurifier designed for treating life-threatening viruses. The San Diego-based company said its Hemopurifier has been validated to capture a “broad spectrum of viruses that are highly glycosylated”, which includes lethal strains of pandemic influenza, mosquito-borne viruses and hemorrhagic viruses with no currently […]
Vascular access device maker Stent Tek closes Series A
Medical device firm Stent Tek said today it closed an undisclosed Series A financing round to support the development of its ePath AVF minimally invasive catheter technology. The ePath AVF device is designed for vascular access as an alternative to surgical fistulas for hemodialysis patients. Money in the round came from institutional investors Julz and […]
Exthera Medical wins FDA EAP designation for Seraph 100 blood filter
Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation. The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding bacteria, including antibiotic […]
Vascular Dynamics touts significant BP reductions in interim MobiusHD trial results
Vascular Dynamics yesterday released interim results from the 1st-in-human trial of its MobiusHD implant designed for treating resistant hypertension, touting significant reductions in ambulatory systolic blood pressure. Results were released at the European Society of Cardiology’s annual meeting in Barcelona. The MobiusHD device is designed to help regulate blood pressure using electrodes implanted in the carotid […]
NxStage Medical wins expanded FDA nod for System One home hemodialysis system
NxStage Medical (NSDQ:NXTM) said today it won expanded FDA clearance for its System One home hemodialysis system, clearing it for use without a care partner during waking hours. The system won initial clearance in 2005 and added clearance for home nocturnal hemodialysis in 2014, the Lawrence, Mass.-based company said, but has always required a care […]
Fast BioMedical raises $8m to support blood volume, kidney function dx tech
Clinical-stage medtech firm Fast BioMedical said it has raised $8 million in mixed funding, with proceeds slated to support its blood volume and kidney function diagnostic technologies, as well as internal growth. The Carmel, Ind.-based company is developing a technology platform to measure blood volume and kidney function in timely, precise and convenient manner, according […]
Becton Dickinson blood tubes under investigation in FDA probe of faulty lead tests
(Reuters) – Blood collection tubes made by Becton Dickinson & Co. (NYSE:BDX) that were used in conjunction with Magellan Diagnostics‘ lead-testing devices are still being investigated as a potential cause of inaccurate lead test results. The FDA in May had warned that Magellan’s LeadCare test systems performed on blood samples might provide inaccurate results. Prior to that, […]
HeartFlow touts 4 positive BCBS policy decisions for its FFRct tech
HeartFlow said today it won positive medical policy decisions from 4 different Blue Cross Blue Shield groups across the US for its HeartFlow FFRct fractional flow reserve technology. The Redwood City, Calif.-based company said that Horizon BCBS of New Jersey, BCBS of Arizona, BCBS of Idaho and BCBS of Kansas City issued determinations supporting the use […]
Cerus posts Street-beating Q2 results
Shares in Cerus (NSDQ:CERS) fell today despite the company beating expectations on Wall Street with its second quarter results. The Concord, Calif.-based company posted a net loss of -$17.1, or -16¢ per share, on sales of $9.5 million for the 3 months ended June 30, for bottom-line growth of 6% on sales growth of 3% compared with […]