Velano Vascular said today it won FDA 510(k) clearance for its Pivo needle-free vascular access device designed for drawing blood. The San Francisco, Calif.-based company said its Pivo is a single-use disposable device designed to take blood samples from indwelling peripheral IV lines to reduce the amount of needle sticks and central line acces for blood […]
Blood Management
Seventh Sense Biosystems wins FDA nod for blood collection device
Seventh Sense Biosystems said today its Tap blood collection device won FDA 510(k) clearance. The company’s push-botton device collects capillary blood for hemoglobin A1C testing without the use of large needles. The Tap device is designed to be placed on the upper arm and blood collection, which takes 2 to 3 minutes, begins with a […]
Arch Therapeutics bumps up dates for FDA submission on AC5 hemostasis device
Arch Therapeutics (OTC:ARTH) today announced it accelerated the timeframe for FDA 510(k) clearance submission for its AC5 hemostasis device, moving from late 2017 to mid-2017. The Framingham, Mass.-based company’s AC5 surgical and topical hemostatic devices are being designed using a self-assembling materials technology platform, seeking to improve hemostasis during surgical, wound and interventional care. “Our anticipated […]
Blood diagnostic dev HemoSonics raises $15m
Point-of-care blood diagnostics platform developer HemoSonics raised $15 million in a new round of equity financing, according to an SEC filing posted this week. The Charlottesville, Va.-based company produces the Quanta rapid diagnostic designed to measure treatable aspects of hemostasis in approximately 15 minutes, according to the company’s website. The device measures treatable aspects of […]
Flow Forward adds $1m to Series A, touts study results
Early stage vascular device developer Flow Forward said today it closed an additional $1 million in Series A funding and touted the completion of a preclinical study and computational fluid dynamics study of its Arteriovenous Fistula Eligibility system. The Olathe, Kan.-based company’s AFE system is a small external blood bump designed to temporarily stimulate […]
Hologic, Grifols close $2B Procleix blood-screening biz sale
Hologic (NSDQ:HOLX) said today that it closed the sale of its stake in the Procleix blood-screening business it runs with Grifols (NSDQ:GRFS) for nearly $1.9 billion. Hologic, which makes the Procleix line, said it dealt its stake for $1.85 billion to Barcelona-based Grifols, which sells the molecular assays and instruments. Blood banks use the products to screen donated blood […]
Edwards Lifesciences wins CE Mark for HemoSphere blood flow monitor
Edwards Lifesciences (NYSE:EW) said yesterday that it won CE Mark approval in the European Union for its HemoSphere blood flow monitor. 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 device includes visual clinical support screens […]
Flashback Technologies wins de novo FDA nod for blood loss algorithm
Predictive data analytics company Flashback Technologies said today it won FDA de novo clearance for devices using its Compensatory Reserve Index algorithm, now cleared as an adjunctive cardiovascular status indicator. The Boulder, Colo.-based company’s CRI product is designed to provide noninvasive, real-time measurement of a patient’s ability to tolerate changes in intravascular volume, such as […]
Z-Medica inks 3-year, $3m QuikClot supply deal with NYPD
Hemostatic device developer Z-Medica said today it inked a 3 year, $2.7 million deal to supply the New York City police department with QuikClot belt trauma kits. The QuikClot belt trauma kit contains the company’s QuikClot combat gauze, a tourniquet, compression bandage and gloves for controlling bleeding in emergency situations, the Wallingford, Conn.-based company said. “Our […]
Cerus raises funds for phase III trial of Intercept red blood cell system
Cerus Corporation (NSDQ:CERS) said today that it exercised $10.8 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. The funds will go towards in vitro pathogen inactivation and red blood cell […]
Hologic deals stake in Procleix blood-screening biz to Grifols for $1.9B
Hologic (NSDQ:HOLX) said yesterday that it agreed to deal its stake in the Procleix blood-screening business it runs with Grifols (NSDQ:GRFS) for nearly $1.9 billion. Hologic, which makes the Procleix line, said it’s selling its stake for $1.85 billion to Barcelona-based Grifols, which sells the molecular assays and instruments. Blood banks use the products to screen donated blood for […]