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MassDevice

 •  January 18

Bluegrass Vascular Technologies said it enrolled the first patients in a pivotal trial of its Surfacer “inside-out” vascular access catheter. The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union in August...

MassDevice

 •  December 18, 2017

Clinical stage medical device company XableCath said today it won FDA clearance for its blunt tip support vascular catheter. The Salt Lake City, Utah-based company said the blunt tip catheter is designed to allow for the the true lumen passage of lesions both above and below the knee in the peripheral vasculature for treating peripheral arterial...

MassDevice

 •  December 7, 2017

A study of catheter-guided thrombolysis in patients with deep-vein thrombosis found no reduction in risk for post-thrombotic syndrome but a higher risk of major bleeding. The study, published in the New England Journal of Medicine, examined 692 patients with acute proximal deep-vein thrombosis, randomized to receive either anticoagulation drugs...

MassDevice

 •  October 4, 2017

Researchers at the University of California at Davis combined ultrasound with light into a catheter probe to view the tiny arteries of the heart. The device uses intravascular ultrasound and fluorescence lifetime imaging (FLIm) to retrieve structural and biochemical information about plaque in the arteries to help predict heart attacks more...

MassDevice

 •  August 30, 2017

Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation. The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding...

MassDevice

 •  August 28, 2017

Medical device developer Access Vascular said today it raised $3.7 million to support its HydroPICC catheter designed to reduce thrombotic risk. The HydroPICC is a peripherally inserted central catheter which the Bedford, Mass.-based company claims can significantly reduce the accumulation of platelets and the risk of thrombosis. Financing will...

MassDevice

 •  August 4, 2017

From MDCorp inking a European distribution deal to Align Technology’s North Carolina expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. MDCorp inks distribution deal with Smart Endoscope Systems MDCorp announced in a July 31 press release that it has signed a distribution agreement with Smart...

MassDevice

 •  March 7, 2017

Bluegrass Vascular Technologies said today that it entered a “strategic relationship” with Merit Medical (NSDQ:MMSI) for its Surfacer “inside-out” catheter that includes an equity stake and a distribution agreement. The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with...

MassDevice

 •  December 15, 2016

ClearLine MD said today that it won CE Mark approval for its ClearLine IV product line that prevents air from being introduced into intravenous lines. During IV infusion, ClearLine’s device detects air in the IV line using ultrasound and then removes the air to allow the fluid to flow continuously. Air embolisms can cause long-term clinical...

MassDevice

 •  October 6, 2016

Baxter (NYSE:BAX) is recalling its 50mm 0.2 micron filter used to filter water-based intravenous solutions due to the presence of particulate mater and the potential absence of filter layers. The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or...