Access Vascular raised more than $3 million from a consortium of new and existing investors that CEO Jim Biggins said should be sufficient to carry the company through a post-market clinical evaluation of its HydroPICC catheter and into the regulatory process for its next iteration. Biggins told MassDevice.com yesterday that the $3.4 million round was led by […]
Catheters
Avinger posts loss on disappointing sales
Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses. The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with […]
NuCryo Vascular inks PolarCath distro deal with Lokai Medical
Privately held cryoplasty developer NuCryo Vascular said today it inked a deal with Lokai Medical to distribute its PolarCath balloon dilation system in the US. San Jose, Calif.-based NuCryo Vascular’s PolarCath system is designed to be used in Balloon Cryoplasty procedures to treat peripheral artery disease. The system has FDA approval and is cleared to […]
AngioDynamics nets a win in antitrust case against BD’s Bard
A federal judge in New York this week denied a motion from Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard to dismiss an antitrust lawsuit filed by AngioDynamics (NSDQ:ANGO) alleging unfair competition, according to an Albany Business Review report. AngioDynamics filed the suit against Bard last May, claiming that the larger company illegally ties the sales of its […]
7 medtech stories we missed this week: August 3, 2018
From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound […]
Thermedical wins FDA nod for Durablate catheter trial
Thermedical said today that it won an investigational device exemption from the FDA for a clinical trial of its Durablate catheter for treating ventricular tachycardia. The Durablate catheter is designed to simultaneously inject hot saline and use radiofrequency energy to effect the ablation; the Thermedical claims that the method is 20 times more effective than conventional RF […]
RenovoRx sets its sights on localized treatment of pancreatic cancer
People living with pancreatic cancer find themselves facing devastating odds – the five-year survival rate is in the single digits, according to the American Cancer Rate. Pursuing treatment often means dealing with the side effects of systemic chemotherapy, including hair loss, fatigue and neuropathy. Shaun Bagai and his team at RenovoRx think that their catheter could help […]
Embolx wins FDA nod for next-gen Sniper balloon occlusion microcath
Embolx said today that it won FDA 510(k) clearance for its next-gen Sniper balloon occlusion microcatheters designed for pressure-directed arterial embolization therapy. The Sunnyvale, Calif.-based company said that improvements to its next-gen Sniper microcath are intended to enhance access and navigation through small complex vascular structures. The catheter is available in 110 cm, 130 cm […]
Avinger launches next-gen Pantheris in US
Avinger (NSDQ:AVGR) said today it launched its next-generation Pantheris in the US, touting that the first procedures with the device have already been performed. Redwood City, Calif.-based Avinger said the newly launched Pantheris device features a single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The system is designed […]
Stereotaxis, J&J’s BioSense Webster extend deal for magnetic ablation catheters
Stereotaxis (NSDQ:STXS) said today it extended a long-term deal with Johnson & Johnson’s (NYSE:JNJ) Biosense Webster to supply it with magnetic ablation catheters. With the extended deal, St. Louis-based Stereotaxis said it will continue to supply Biosense Webster’s catheters, and will continue to receive a royalty for the sale of those catheters. The deal includes Biosense Webster’s Navistar […]
FDA grants de novo clearance to hemodialysis catheters from Avenu Medical, TVA Medical
The FDA today granted de novo clearance to a pair of companies that make catheters designed for hemodialysis, Avenu Medical and TVA Medical. The federal safety watchdog said the catheters are designed to create an arteriovenous fistula connecting veins and arteries for a less-invasive way to access the vascular system. Avenu’s device is called Ellipsys; […]