An Abbott (NYSE:ABT) recall of certain coronary dilation catheters is Class I — the most serious type of recall, FDA said today. The recall, which Abbott originally announced Jan. 29, involves nearly 14,000 NC Trek RX coronary dilatation catheters and NC Traveler RX coronary dilatation catheters with 4.0 mm, 4.5 mm and 5.0 mm balloon diameters. […]
Catheters
JenaValve raises $50m for TAVR tech
JenaValve Technology announced that it raised $50 million in equity financing as it develops and manufactures the JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for treating aortic valve disease. Bain Capital Life Sciences led the funding round, while Andera Partners, Gimv, Legend Capital, NoMed Management, RMM, Valiance Life Sciences and VI Partners all participated, […]
CloudCath raises $12m for at-home dialysis monitoring software
CloudCath announced today that it completed a $12 million Series A financing round for its at-home dialysis monitoring treatment platform. San Francisco–based CloudCath’s system, which is its first product, is designed to enable remote, real-time monitoring for people undergoing at-home peritoneal dialysis to allow for earlier complication intervention. Proceeds from the funding round are also […]
Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter
Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system. The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that limit central venous access through […]
FDA clears Rist Neurovascular radial artery catheter
Rist Neurovascular announced today that it won FDA 510(k) clearance for its Rist Cath radial access long sheath for accessing the neurovasculature through the radial artery in the wrist. The Miami Beach, Fla.–based company touts the Rist Cath as the first device specifically designed to access the neurovasculature through the radial artery, which could open […]
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 […]
Teleflex recalls certain Arrow epidural catheterization kits in Europe
Teleflex (NYSE:TFX) subsidiary Arrow issued an urgent field safety notice in Europe to warn of failures with the loss of resistance (LOR) syringes including in epidural catheterization kits. The company received complaints regarding the syringes in the kits that revealed dural puncture with some also requiring a blood patch. An inadvertent dural puncture may lead […]
Thrombolex raises $9.8m for its endovascular catheters
Thrombolex filed an amendment to its SEC Form D to reveal that the company sold nearly $10 million in a debt offering. The New Britain, Pa.-based company made the first sale in the offering of debt and convertible promissory notes on April 6, 2017. No issuer size was disclosed for the offering, which included contributions […]
These medical device companies provide the most research payments
The worlds largest medical device companies are spending tens of millions of dollars a year on research payments to doctors and teaching hospitals — but the payments only make up a tiny fraction of their budgets. That was a big takeaway from an analysis of Medical Design & Outsourcing‘s annual Big 100 and the most […]
Edwards Lifescience boosts 2020 guidance amid strong TAVR sales
Edwards Lifesciences (NYSE:EW) saw its stock jump in after-hours trading today after the company boosted its 2020 guidance amid positive fourth-quarter TAVR sales. The Irvine, Calif.–based cardio device and critical care monitoring company’s Q4 results were mixed. But there was also the news that worldwide TAVR sales were up 30% year-over-year in Q4, to $763 million, […]
Imricor Medical Systems ablation catheter wins CE mark
Imricor Medical Systems today said it won CE mark approval for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode. “We are absolutely thrilled to bring to market our products for performing cardiac catheter ablations guided by real-time MRI,” chairman and CEO Steve Wedan said in a news release. “Receipt of CE mark approval marks a […]