Getinge subsidiary Maquet Cardiovascular is recalling its Quart arterial filter, used during coronary bypass surgery, because transportation may compromise its sterile packaging. A transportation simulation test revealed the problem, according to an August 27, 2019, letter to customers. Patients who are exposed to non-sterile medical devices while undergoing extracorporeal circulation may develop an infection and […]
Access Vascular logs GPO win with Premier contract
Access Vascular said today that it won a group purchasing agreement for a breakthrough technology with Premier for the HydroPICC peripherally inserted central catheter. Bedford, Mass.-based Access Vascular’s HydroPICC is indicated for reduced thrombus accumulation. The catheter body is composed of biocompatible biomaterial, instead of the standard polyurethane as the material for the body. The […]
T2 Biosystems jumps on $69m BARDA deal
T2 Biosystems (NSDQ:TTOO) this week said that it inked an up to $69 million diagnostics deal with a U.S. Defense Dept. research program. Lexington, Mass.-based T2 Biosystems signed a maximum $69 million funding deal with the Health and Human Services Office of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research & Development Authority for […]
Fresenius recalls dialysis tubes due to dangerous, undetectable leaks
Fresenius Medical Care (NYSE:FMS; ETR:FRE) last week recalled two sets of its bloodlines due to potentially deadly leaks in the tubes. Germany-based Fresenius said that two sets of its 4008 bloodlines (AV-Set B-R F00001124 and AV-Set SRB-R F00000257) containing a total of 25 batches experienced tube rupture that led to blood leakage. A dialysis machine cannot […]
LabCorp gets in on $17.5m round for Boston Microfluidics
Boston Microfluidics said today that it raised $17.5 million in Series A funding for its R&D efforts, as first reported by MassDevice.com. Cambridge, Mass.-based Boston Microfluidics produces blood collection devices designed to simplify the blood testing process. Proceeds from the round are slated for continued improvement of its existing product line and the development of […]
Avinger closes $5m offering
Avinger (NSDQ:AVGR) said yesterday that it closed a stock offering worth nearly $4.5 million for its line of devices designed to treat peripheral artery disease. The commercial-stage medical device company designs image-guided, catheter-based systems to diagnose and treat PAD. The closing of the equity offering came five days after the company priced the offering, as […]
Vyaire recall hits Medline’s Centurion Medical
Medline Industries recalled Centurion Medical’s primary warmer pack because it contains Vyaire Medical‘s recalled enFlow disposable cartridge that potentially exposes patients to unsafe aluminum levels. Nearly three million enFlow disposable cartridges were recalled in March. The product is designed to warm blood, blood products and intravenous solutions before IV administration, but the potential for aluminum […]
Perfuze lands breakthrough designation for Millipede clot ingestion system
Perfuze yesterday announced that the FDA granted its Millipede CIS technology Breakthrough Device Designation. Millipede CIS is a catheter technology that removes clots from the brain after an acute ischemic stroke. The Breakthrough Device Designation was granted based on its potential to offer advantages over other alternative treatment of acute ischemic stroke, according to the […]
ExThera Medical wins CE Mark approval for blood filter
ExThera Medical yesterday said it received CE Mark approval for is Seraph 100 Microbind Affinity Blood Filter. The Seraph 100 is designed to reduce pathogens during bloodstream infections and the CE Mark allows the filter to be used as an adjunct to anti-infective therapy. ExThera’s filter quickly lowers the concentration of bacteria, viruses and fungi […]
Haemonetics wins expanded FDA nod for TEG 6s hemostasis analyzer
Haemonetics (NYSE:HAE) said on Monday that it won expanded FDA 510(k) clearance for its TEG 6s hemostasis analyzer system, now indicated for use in adult trauma settings. The TEG 6s system is comprised of an analyzer, disposable cartridges and software and is intended to provide a rapid and accurate identification of a patient’s hemostasis condition, the […]
Haemonetics deals S.C. plant to CSL Plasma for $10m
Haemonetics (NYSE:HAE) said today that it agreed to sell a plant in South Carolina to CSL Plasma for $10 million. The Union, S.C., facility makes the liquid saline and sodium citrate solutions used in plasma collection. CSL Plasma, the supplier for CSL Behring, will own and operate the plant, taking on “substantially all” of the roughly […]
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