Innovative Cardiovascular Solutions said today it raised $5 million in an oversubscribed Series B round of financing to support its Emblok embolic protection system. The Emblok system is an embolic protection device designed for full circumferential aortic collection while protecting the cerebral, abdominal and peripheral vasculature from embolic debris. The system is designed for use […]
Blood Management
GE Healthcare inks deal to integrate HeartFlow FFRct into CT scanners
GE Healthcare (NYSE:GE) said today it inked a collaborative deal with HeartFlow to integrate its FFRct fractional flow technology into GE’s computed tomography scanners. HeartFlow’s FFRct software is designed to aid in the diagnosis and treatment of patients with suspected coronary artery disease, providing insight into the extent of the CAD and the impact it is […]
Outset Medical raises $4m
Outset Medical has raised $4.3 million in a new round of mixed financing, according to an SEC filing posted this week. The San Jose, Calif.-based company develops and produces the Tablo hemodialysis system, an all-in-1 dialysis machine designed to handle water purification and dialysate production and be used in a variety of different settings. Money […]
ClearFlow wins FDA 510(k) for FlowGlide
ClearFlow said today it won FDA 510(k) clearance for its FlowGlide active clearance technology system designed to prevent or reduce clot occlusions during chest drains. The Anaheim, Calif.-based company said that the device is designed to prevent retained blood syndrome, which can be detrimental to outcomes after cardiothoracic surgery and may require late interventions. “ClearFlow is […]
Aethlon looks fast-track FDA nod for Hemopurifier blood filter through EAP
Aethlon Medical (NSDQ:AEMD) said today it is submitting an expedited access pathway application to the FDA seeking a breakthrough technology designation for its hemopurifier. Aethlon’s Hemopurifier device is a single-use, disposable cartridge designed to target and filter out viruses or tumor-secreted exosomes. Blood flows through the cartridge into nearly 3,000 hollow fibers with pores 250 nanometers in diameter. […]
Internal bleeding detection device dev Saranas raises $4m in Series B
Internal bleeding detection device developer Saranas said today it has raised $4 million in a Series B round of financing to support its Early Bird bleed detection device. The Early bird device is designed as a standard vascular access sheath which is embedded with sensors which detect bleeding from accidentally ruptured blood vessels during cardiac […]
Baxter touts Sharesource in-home peritoneal dialysis patient monitoring study data
Baxter (NYSE:BAX) today released data from multiple studies of its Sharesource remote patient monitoring technology used for peritoneal dialysis patient care. Data from the study was presented at the 54th Congress of the European Renal Association and European Dialysis and Transplant Association meeting this week. Sharesource is a 2-way cloud-based technology offered with the company’s Homechoice […]
FDA clears Ethicon’s Surgicel powdered hemostat
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won FDA approval for its Surgicel powder absorbable hemostat designed as an adjunctive hemostatic solution to control continuous oozing on broad or raw surfaces. The Surgicel powdered hemostat is comprised of oxidized regenerated cellulose, the base component in all of its Surgicel products. The powdered solution comes […]
Baxter touts HDx Theranova data for ‘extended’ hemodialysis
Baxter (NYSE:BAX) today released data from 2 independent studies of its novel HDx therapy using the Theranova dialyzer, touting the effective removal of small and mid-sized toxins at similar rates compared to hemodiafiltration. Results from the trial were presented at the 54th Congress of the European Renal Association and European Dialysis and Transplant Association this week, […]
Stago closes HemoSonics buy
Stago Group said today that it completed its acquisition of point-of-care blood diagnostics platform developer HemoSonics. Charlottesville, Va.-based HemoSonics developed the Quanta Hemostasis Analyzer, which is designed to measure treatable aspects of hemostasis in approximately 15 minutes using its sonic estimation of elasticity via resonance (SEER) technology. Financial details of the acquisition were not disclosed. […]
Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu
Cerus (NSDQ:CERS) said today that it expects a U.S. supply shortage of Fresenius Kabi’s (NYSE:FMS) platelet additive solution will impact blood centers that use PAS to produce Intercept platelets. The pending shortage is due to “an unanticipated delay” in FDA approval of a plastic component used to manufacture the PAS container. The original component was discontinued […]