The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Merit Medical Systems Inc. (NSDQ:MMSI) and American Regents Inc. both issued recalls.
Merit told its customers to immediately stop using one of the company’s vascular catheter sheaths.
The South Jordan, Utah-based company’s Prelude catheter introducer’s tip may detach during use, a failure that could allow the part to enter the bloodstream, according to the Food & Drug Administration.
Teleflex Medical Inc. (NYSE:TFX) subsidiary Arrow International issued a voluntary global recall of its 5800 Series intra-aortic balloon catheters with Super Arrow-Flex Sheath Introducer because of an increase of "stuck in sheath" reports.
The Food & Drug Administration classified the recall as Class I because there is a “reasonable probability” that the use of products could cause "serious adverse health consequences or death," according to the company.
TriReme Medical Inc. completed its $17 million Series D financing round.
Bio*One Capital PTE LTD led the financing; current investors Three Arch Partners and Adams Street Partners also contributed "strong support," according to Singapore-based Bio*One’s parent company EDB Investments PTE LTD.
Cleveland Clinic spinoff Clear Catheter Systems Inc. raised $1.2 million in equity to help support the launch of its lead product, PleuraFlow.
The Bend, Ore.-based company’s PleuraFlow active tube-clearance system uses magnets and a wire loop to keep catheters clear while draining blood and other fluids from the chest after heart or lung surgery. Passive tubes can clog, posing threats like infection and death.
VasoNova Inc. will begin selling its Vascular Positioning System central venous catheter navigation technology through Marlborough, Mass.-based Navilyst Medical Inc.
The Menlo Park,Calif.-based vascular products maker last week signed the distribution agreement with Navilyst.
A major battlefield in the stent wars opens again this week, as thousands of cardiologists and other healthcare providers flock to Washington, D.C., for the annual Transcatheter Cardiovascular Therapeutics conference.
Medical device industry players large and small are busy hawking the results of clinical trials and touting new products — or new versions of older products. TCT 2010, which kicked off yesterday, is slated to run through Sept. 25.
Corindus Vascular Robotics announced the results of the first clinical study of the CorPath 200 System and invites attendees of the Transcatheter Cardiovascular Therapeutics (TCT) 2010 conference (September 21-25 in Washington, DC) to experience firsthand the CorPath 200 System.
Nonprofit PediaWorks LLC has formed a for-profit venture with a Japanese company that will specialize in developing catheters for children.
The new company, PediaCath, will be thefirst and only company dedicated to catheters made exclusively for children, according to a statement from PediaWorks.
SonoSite Inc. (NSDQ:SONO) won 510(k) clearance from the Food & Drug Administration for its LumenVu catheter guidance system.
The Bothell, Wash.-based portable ultrasound maker said it designed the system to increase the accuracy of peripherally inserted central catheter placement. Physicians incorrectly place 30 percent of peripherally inserted central catheters, according to the company.
By Mary Vanac
Great Lakes Pharmaceuticals Inc. closed a $3.1 million Series B equity offering led by Charter Life Sciences, the Palo Alto, Calif.-based venture capital firm with an office in Cincinnati.
The company, formed by Case Western Reserve University, University Hospitals Case Medical Center and Ricerca Biosciences LLC in 2005, plans to use the investment to complete a pivotal clinical study of B-Lock, its anti-microbial catheter lock solution.
Boston Scientific Corp. (NYSE:BSX) garnered both a CE Mark and Food & Drug Administration pre-market approval for its NC Quantum Apex PTCA dilation balloon catheter.
The post-dilation device is designed to optimize coronary stent deployment; according to the company’s POSTIT study, the device improves the accuracy of stent deployment compared with a stent delivery balloon alone.
