Vascular Graft Solutions has reported the first clinical use of its Frame external support technology in high-flow arteriovenous (AV) fistulas. The first five cases were performed by Dr. Vladimir Matoussevitch from Cologne University Hospital in Germany. The braided cobalt chrome, kink-resistant external support was designed for autologous vein grafts in bypass or reconstruction of peripheral arterial
Vascular Graft Solutions’ aneurysm graft used in hemodialysis patients
August 20, 2018 By Leave a Comment
ValenTx raises $10.3 million for implantable gastric bypass device
August 17, 2018 By Leave a Comment
Startup ValenTx has attracted nearly $10.3 million from 32 investors, according to a filing with the Securities & Exchange Commission. The Maple Grove, Minn. company is developing a removable gastric bypass device as an alternative to Roux-en-Y gastric bypass surgery. It raised $10,271,050 in the round begun July 18, 2018. The ValenTx endoluminal bypass therapy
Lessons learned: How Jeff Karp stays at the forefront of innovation
August 16, 2018 By Leave a Comment
Serial entrepreneur Jeff Karp has a philosophy for his laboratory: find important problems and get solutions to people quickly. To learn about the exciting technologies emerging from Karp’s lab, join us at DeviceTalks Boston on Oct. 8-10. After Jeff finished his PhD in chemical and biomedical engineering at the University of Toronto, he knew he wanted
SPR Therapeutics’ new PNS system wins FDA nod
August 16, 2018 By Leave a Comment
The FDA has approved SPR Therapeutics’ (Cleveland) Sprint endura (single lead) and extensa (dual lead) peripheral nerve stimulation (PNS) systems. The minimally invasive Sprint system is the only FDA-approved percutaneous PNS system that is indicated for up to 60 days in the back and/or extremities for both chronic and acute pain and is the industry’s only
SpaceLabs’ Arkon anesthesia system recalled again
August 13, 2018 By Leave a Comment
The FDA has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use
ElectroCore launches gammaCore Sapphire migraine treatment device
August 10, 2018 By Leave a Comment
ElectroCore announced that it has launched its gammaCore Sapphire non-invasive vagus nerve stimulator in the U.S. The device is the first non-invasive vagus nerve stimulator device to be cleared by the FDA for acute treatment of pain from migraines and episodic cluster headaches. The gammaCore Sapphire device is portable and easy-to-use and can be self-administered
How Insulet’s CEO plans to create a billion-dollar business
August 10, 2018 By Leave a Comment
When Pat Sullivan joined Insulet (NSDQ:PODD) in 2014, the Billerica, Mass.-based company was reeling in roughly $300 million in revenue selling its Omnipod tubless insulin delivery system. Sullivan, a veteran of the medtech industry, saw a path to creating a billion-dollar company and it centered around the concept of making life easier for people with diabetes. “I
Northwell’s prosthetic leg could get amputees back in the swim
August 7, 2018 By Leave a Comment
A New York State heathcare provider has developed a 3D-printed artificial leg to help combat veterans and other amputees to swim again. Northwell Health’s prosthetic, “The Fin,” is the first such prosthetic leg attachment to give amputee swimmers the ability to navigate from land to the water and back without having to switch prosthetics. Northwell has begun
Surmodics’ acquisition hits earnings bottom line
August 7, 2018 By Leave a Comment
Surmodics (NSDQ:SRDX) today posted earnings that beat expectations on Wall Street and adjusted its guidance for the remaining year. The Eden Prairie, Minn. company took an expected hit to earnings due to its $5 million-plus acquisition of Embolitech’s thrombectomy platform. Surmodics posted a net loss of -$2.68 million compared with a profit of $720 million
NextGen Medical targets clots in large vessels
August 6, 2018 By Leave a Comment
NexGen Medical Systems announced the successful completion of the first human use of its XCOIL large vessel (18mm) thrombectomy system for the treatment of deep vein thrombosis (DVT). The new device represents an expansion of the company’s 12mm XCOIL system and is designed to rapidly remove blood clots in large vessels, such as the
The 10 most innovative medical devices of 2018
August 6, 2018 By Leave a Comment
The nominees for the best medical technology of 2018 were recently announced for the 12th Annual Prix Galien USA Awards. The host of the awards, The Galien Foundation, awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Before the candidates can qualify
Medtech stories we missed this week: August 3, 2018
August 3, 2018 By Leave a Comment
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 systems.
Integer misses Wall Street mark in Q2
August 2, 2018 By Leave a Comment
Integer Holdings (NYSE:ITGR) earnings for the second quarter fell below Wall Street estimates. The Frisco, Texas-based medical device contract manufacturer posted profits of $23 million or 70¢ per share, on sales of $314 million for the three months ended June 29. Earnings per share were 18¢ behind the average estimate on Wall Street, where analysts were looking
This medical air mist could eliminate hospital-acquired infections
August 2, 2018 By Leave a Comment
Researchers at the University of California in San Diego have developed a medical misting device that can diffuse potent disinfectants into the air. The device has worked with a number of disinfectants that have not been atomized before, like Triethylene glycol. The researchers used the device to atomize disinfectants onto environmental surfaces that were contaminated
VisCardia heart failure implant study underway in Ukraine
August 2, 2018 By Leave a Comment
Novel heart failure device developer VisCardia, Inc. (Portland, Ore.) announced the first implant of the VisONE system for heart failure and the launch of the system’s heart failure pilot study in Ukraine. The VisONE implantable system delivers asymptomatic diaphragmatic stimulation (ADS) therapy to improve cardiac function. A surgeon laparoscopically implants a medical device equipped with electrodes to deliver
