MassDevice

MassDevice
Share

MassDevice

 •  December 7

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

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

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

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

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

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...

MassDevice

 •  July 14, 2016

Pavmed (NSDQ:PAVMU) said today that it’s planning to submit an application for FDA clearance for its 1st product, the PortIO long-term implantable vascular access device, during the 4th quarter. New York City-based Pavmed said the PortIO device is in the verification and validation testing phase, the final stage of pre-submission testing. The...

MassDevice

 •  March 21, 2016

ICU Medical (NSDQ:ICUI) said today it inked a long-term distribution deal with B. Braun Medical for ICU’s SwabCap disinfecting cap for needlefree connectors for select countries outside the U.S. San Clemente, Calif.-based ICU Medical’s SwabCap is a disposable cap designed for disinfecting needlefree connectors with 70% isopropyl alcohol when...