CytoSorbents (OTC:CTSO) said today it’s dropping its pursuit of the FDA’s fast-track Expedited Access Pathway for its CytoSorb for treating sepsis. The decision came after meeting with the FDA’sCenter for Devices and Radiological Health and Center for Drug Evaluation and Research in which the company came to the conclusion that “there would be no significant time […]
Blood Management
LabStyle’s Dario glucose monitor wins FDA 510(k)
Diabetes focused mobile-health developer LabStyle Innovations said today it won FDA 510(k) clearance for its Dario blood glucose monitoring system, including its blood test strips and the Dario app for Apple (NSDQ:AAPL) iOS devices. The system is designed to operate around a smartphone and a small glucose meter that communicates with the phone through the audio jack, the […]
Med society sponsored IVC study gets underway
A multi-center, 2,100 patient, 5-year study of inferior vena cava filters has begun enrollment, bringing in its 1st 9 patients at 10 initial medical sites. The study aims to examine the safety and effectiveness of the small, cage-like devices that are implanted to prevent life-threatening blood clots from reaching the heart or lungs. “The treatment […]
Australian AtCor jumps on Japanese A&D distro deal
AtCor Medical Holdings said today it inked an exclusive, multi-year distribution deal with A&D Company to distribute the AtCor SphygmoCor Xcel device in Japan, sending stocks up as much as 10%. The SphygmoCor Xcel provides both central blood pressure and pulse wave velocity, which the Japanese Society of Hypertension have set as a marker of […]
Avenu Medical pulls in $6m for Ellipsys AV fistula device
Vascular access system maker Avenu Medical raised $6 million in a new round of debt financing, according to an SEC filing. Avenu Medical, founded in 2010, is developing and producing the Ellipsys vascular access image-guided catheter system, designed to percutaneously create arteriovenous fistulas for hemodialysis access. Funds came from 46 anonymous investors, according to an SEC […]
ExThera wins nod for CE Mark trial for Seraph blood filter
ExThera Medical said it won approval for a CE Mark trial for its Seraph blood filter, which is designed to remove pathogens from the bloodstream. Berkeley, Calif.-based ExThera said Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte approved the protocol for a trial of the Seraph device in treating dialysis patients with Staphylococcus aureus and MRSA bloodstream infections. “Certain bloodstream […]
IMBiotechnologies treats 1st patient in OCL 500 study
IMBiotechnologies said last week it treated the 1st patient in a clinical trial of its biodegradable OCL500 embolization microspheres to treat uterine fibroids. The OCL500 microspheres are designed to rapidly form site-specific, platelet-rich clots that cut off the blood supply to target tissues and completely biodegrade over time, Canada-based IMBiotechnologies said. “We are pleased to announce […]
Cheetah Medical joins CMS in setting sights on sepsis care
Cheetah Medical is joining the Centers for Medicare and Medicaid Services in focusing on improving the treatment of sepsis in hospitals across the U.S. The Centers for Medicare and Medicaid Services released new federal reporting requirements for treating hospitalized sepsis patients on October 1. The new rules aim to monitor how sepsis is managed within […]
FDA grants expedited access for UW’s wearable artificial kidney
The FDA granted expedited access pathway status for a Wearable Artificial Kidney being developed at the University of Washington’s Medical Center in Seattle, the school reported earlier this month. The Wearable Artificial Kidney is a battery-powered hemodialysis machine composed of miniaturized components worn as a tool belt and connected to the patient via catheter, UW Medical said. The […]
Spectral Medical inks distribution deal with Fresenius
Septic shock treatment developer Spectral Medical said today it inked a deal with Fresenius Medical Care to distribute its Endotoxin activity assay devices. Fresenius will be the non-exclusive distributor of the device in Germany, Denmark, Sweden, Finland, Norway, Poland, Hungary and the Czech Republic, the company said. “We are very pleased to have entered into […]
iHealth Lab launches iHealth Ease blood pressure monitor
California mobile devices maker iHealth Lab said Tuesday it commercially launched its iHealth Ease app-based blood pressure monitor. The iHealth Ease is a blood pressure monitor and cuff that is controlled through an app available through either Apple‘s (NSDQ:AAPL) iTunes or Google‘s (NSDQ:GOOG) Android app store. “Priced under $40 and loaded with advanced features, the app-based iHealth […]