FDA has designated Cook Medical's recall of its Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers as Class I, its most serious level. Cook Medical initiated the recall on Nov. 24. It involves 37,326 of the devices, which are used to deliver medical devices to blood vessels (though not vessels of the heart and brain). The … [Read more...] about Cook Medical has a serious catheter recall
Medtronic has a Class I recall involving balloon catheters to treat heart defects
FDA today designated a Medtronic recall of Rashkind balloon septostomy catheters as Class I, its most serious level. The balloon catheters create an atrial septal defect or to enlarge an existing atrial septal defect in order to treat congenital heart defects. Medtronic (NYSE:MDT) initiated a recall of the Rashkind balloon septostomy … [Read more...] about Medtronic has a Class I recall involving balloon catheters to treat heart defects
J&J wins FDA approval for ablation catheter
Johnson & Johnson (NYSE:JNJ) recently announced that its Biosense Webster business has secured FDA approval for its Thermocool SmartTouch SF ablation catheter. The Thermocool SmartTouch received approval for the treatment of persistent atrial fibrillation, J&J announced yesterday. The approval came after results from the 381-patient, … [Read more...] about J&J wins FDA approval for ablation catheter
These startups are advancing catheter-related medtech
Catheter-related medtech remains an exciting and innovative field — if our sister site Medical Design & Outsourcing's latest list of startups to know is any indication. For example, Neurescue (Copenhagen) touts its aortic occlusion catheter as the first of its type with computer-aided, intelligent safety feedback — and pressure-limited … [Read more...] about These startups are advancing catheter-related medtech
Okami Medical raises $7.2m to support vascular occlusion system
Months after the first use of its LOBO vascular occlusion system on patients, Okami Medical has raised more than $7.2 million. The company's low-profile embolic device features a microcatheter to provide smooth peripheral vasculature navigation. When deployed, the occluder self-expands, conforming to a range of targets such as curved … [Read more...] about Okami Medical raises $7.2m to support vascular occlusion system
Freudenberg Medical completes extractables testing for its PharmaFocus Premium tubing
Freudenberg Medical (Carpinteria, Calif.) today touted extractables testing performed on its PharmaFocus Premium silicone tubing used in biopharma fluid processing and single-use applications. Eurofins Lancaster Laboratories conducted the independent extractables testing for Freudenberg Medical, drawing on BPOG and USP 665 protocols. “We … [Read more...] about Freudenberg Medical completes extractables testing for its PharmaFocus Premium tubing
Applied Plastics has a new website, online store
Applied Plastics (Norwood, Mass.) — maker of PTFE-coated products for advanced catheter systems — announced today that it is rebranding to improve its customer interface and support continued growth. The rebranding includes a new website, online store and refreshed brand identity. The company this week is showing off the new look and its online … [Read more...] about Applied Plastics has a new website, online store
Accu-Tube acquires Mercury Tube
Stainless steel tubing outfit Accu-Tube announced today that it has acquired Mercury Tube, another metal tube manufacturer in its home base of Englewood, Colo. Mercury Tube, which makes high-precision stainless steel and high nickel alloy tubing, will operate as a wholly-owned subsidiary of Accu-Tube. Financial terms of the deal were not … [Read more...] about Accu-Tube acquires Mercury Tube
CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system
CardioFocus is seeking a PMA supplement with FDA so that it can launch its next-gen HeartLight X3 endoscopic ablation system in the U.S. The move comes more than 10 months after Marlborough, Mass.–based won a CE Mark in Europe for the device, which is used to treat AFib. CardioFocus plans to launch HeartLight X3 in the U.S. immediately after … [Read more...] about CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system
W.L. Gore officials think they can spur insulin delivery system innovation
W.L. Gore announced this week that it is investing in PhysioLogic Devices, a startup developing an implantable intraperitoneal insulin delivery system. The size of the investment was not disclosed. But it was part of Gore's Micro-Equity Investment (MEI) program, which provides investments of up to $500,000. W.L. Gore officials think the … [Read more...] about W.L. Gore officials think they can spur insulin delivery system innovation
