Terumo Corp. (TYO:4543) said today it launched the Miplate clinical trial of its Mirasol pathogen reduction technology system and enrolled the 1st patient in the study. In the trial, Terumo will look to evaluate the effectiveness of Mirasol-treated apheresis platelets in plasma versus standard apheresis platelets in plasma, hoping that the data will support FDA premarket […]
Blood Management
Army backs feasibility study for Teleflex’s RePlas freeze-dried plasma
Teleflex (NYSE:TFX) said today that it launched the Phase I trial of its RePlas lyophilized fresh frozen plasma product being developed with the U.S. Army Medical Material Development Activity. The freeze-dried plasma technique was 1st developed by Vascular Solutions, which was acquired for $1 billion by Teleflex in February. The 24-patient study is designed to assess safety and […]
First patient transfused with Intercept red blood cells in Phase III trial
Cerus (NSDQ:CERS) said today that the 1st patient was transfused in Puerto Rico in a clinical trial comparing red blood cells processed with its Intercept blood system to conventional red blood cells. Concord, Calif.-based Cerus is developing the Intercept blood system, a pathogen reduction device designed to inactivate a broad range of viruses, bacteria, parasites […]
NxStage wins FDA nod for next-gen System One hemodialysis system
NxStage Medical (NSDQ:NXTM) said today it won FDA 510(k) clearance for its next generation System One hemodialysis system. The newly cleared system includes a new touchscreen user interface and integrated blood pressure monitor designed to enhance ease of use for home hemodialysis patients, the Lawrence, Mass.-based company said. “Early customer and patient feedback in the UK on our next […]
Cerus lands $47m for Intercept red blood cell system
Cerus (NSDQ:CERS) said today that it exercised $46.6 million in additional options from its contract with the Biomedical Advanced Research & Development Authority, a part of the U.S. Dept. of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. Concord, Calif.-based Cerus is developing the Intercept blood system, a pathogen reduction device designed […]
CytoSorbents touts Refresh trial study data
CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery. Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week. The Monmouth Junction, N.J.-based company’s CytoSorb […]
Cerus shares fall after Q1 miss
Shares in Cerus Corp. (NSDQ:CERS) fell -18% today after the company missed expectations on Wall Street with its 1st quarter results. The Concord, Calif.-based company posted a net loss of -$18.7 million, or -18¢ per share, on sales of $7 million for the 3 months ended March 31, for bottom-line loss of -10.7% on sales growth of […]
Baxter looks to combination device pathway for home peritoneal dialysis machine
Baxter (NYSE:BAX) said today that after communicating with the FDA, it will pursue a regulatory pathway as a combination product for its new home peritoneal dialysis solution system. The system is desigend to produce sterile PD solutions using a small water filtration device designed to be placed in a patient’s home and integrated into its AMIA […]
Outset Medical raises $76.5m Series C to support Tablo all-in-1 hemodialysis system
Outset Medical said today it raised $76.5 million in a Series C equity funding round to support its Tablo hemodialysis system. The Tablo system is an all-in-one dialysis machine which handles both water purification and dialysate production and is designed to be used in a variety of settings, CEO Leslie Trigg told MassDevice.com. The system is […]
Edwards wins FDA nod for HemoSphere monitoring platform
Edwards Lifesciences (NYSE:EW) shares rose this morning after the company said it won FDA clearance for its HemoSphere advanced monitoring platform. Hemodynamic monitoring, the measurement of a patient’s blood circulation and cardiac function, enables clinicians to evaluate whether a patient is receiving enough oxygen to their organs and tissues. The Irvine, Calif.-based company’s blood monitoring device is […]
BioDirection raises $2m for concussion device
BioDirection said today it raised $2 million in interim financing to support the clinical development of its Tbit point-of-care blood test for concussion diagnosis. The round was joined by Provident Healthcare Capital, MedScience Ventures and others, the Boston-based company said. The financing round brings the total raised for the company up to approximately $12 million. […]