(Reuters) – Blood-testing company Theranos Inc was sued on Thursday, accused of endangering customer health through “massive failures” that misrepresented the accuracy and quality of its blood tests, according to court papers. The proposed class action was brought in the U.S. District Court for the Northern District of California by the law firm Hagens Berman […]
Blood Management
Cerus wins Health Canada approval for Intercept blood system
Cerus Corp. (NSDQ: CERS) said today it won Health Canada approval for its Intercept blood system designed to reduce the risk of transfusion-transmitted infections in blood plasma. The Concord, Calif.-based company said the system is now cleared in Canada to be used for the ex vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma to reduce the […]
Layoffs ahead as Haemonetics restructures, names new CEO
Haemonetics (NYSE:HAE) said yesterday that it plans to take a pre-tax charge of $26 million, including $17 million worth of “termination benefits,” as part of another round of layoffs aimed at boosting profitability and growth. The Braintree, Mass.-based blood management company also said it named Chris Simon to be its new CEO, replacing interim chief Ron […]
US regulators aim to ban founder of blood-testing firm Theranos
(Reuters) – U.S. federal health regulators have proposed banning Theranos Inc founder Elizabeth Holmes from the blood-testing business for at least 2 years after determining that the company failed to fix certain problems at its California laboratory, the Wall Street Journal reported. The Centers for Medicare and Medicaid (CMS), in its letter dated March 18, said […]
Seventh Sense launches pivotal trial for Tap100 blood draw device
Seventh Sense Biosystems said today it launched a pivotal trial for its Tap100 touch activated blood collection device. Medford, Mass.-based Seventh Sense said it expects to file for marketing authorization in the U.S. and European Union in the 2nd quarter of 2016, with a hopeful date for CE Mark approval in the European Union and […]
FDA clears Nephros after 2015 warning letter
Nephros (OTC:NEPH) said last week it received a notice from the FDA closing out a warning letter the company received last May concerning issues with the manufacturing of a variety of its filtration systems. The warning from the federal watchdog to River Edge, N.J.-based Nephros included warnings on a failure to document and evaluate potential suppliers and […]
Grifols puts up $100m for a 49% stake in Interstate Blood Bank
Grifols (NSDQ:GRFS) said today that it agreed to pay $100 million for a 49% stake in plasma collector Interstate Blood Bank. The deal includes an option to buy the remaining 51% for another $100 million and a $10 million call option, Barcelona-based Grifols said. IBB collects blood plasma so that is can be fractionated into blood […]
Gauss Surgical raises $13m in Series B for blood loss app
Gauss Surgical said today it closed a $12.6 million Series B financing round to support its real-time surgical blood loss monitoring platform. The company said the addition brings the total funds raised up to $24.6 million. The round was led by Providence Health & Services investment arm Providence Ventures, with participation from Chicago-based Jump Capital and existing […]
FDA weighs dangers of faulty readings from blood clot monitors
The FDA is considering possible dangers from medical devices that monitor blood clotting producing false readings, according to a report from The Wall Street Journal. The FDA has tracked thousands of cases of malfunctions from such devices over the years, the WSJ reports. Deaths and serious injuries have been linked with the erroneous readings, due […]
Next-gen blood collection device maker Magnolia Medical raises $1.4m
Seattle-based Magnolia Medical Technologies brought in $1.4 million in a new round of debt financing and looks to bring in another $1.6 million before closing the round, according to an SEC filing posted last week. Magnolia produces the SteriPath vacuum-assisted blood collection system designed to divert and sequester contaminants from the initial blood sample specimen, […]
Becton Dickinson wins CE Mark for blood separation tech
Becton Dickinson & Co. (NYSE:BDX) said today it won CE Mark approval in the European Union for its Vacutainer Barricor next-gen blood separation technology. The Vacutainer Barricor tubes from Franklin Lakes, N.J.-based Becton Dickinson are single-use, plastic evacuated tubes used to collect, separate, transport and process venous blood specimens for obtaining high-quality plasma for in vitro diagnostic use, […]